Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).
This page lists clinical trials related to Parasitic Diseases from the ClinicalTrials.gov database.
Trial Summary
- Total studies: 50
- Recruiting: 23
- Active, not recruiting: 2
- Completed: 14
- Other: 11
Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.
Recruiting Trials
NCT00001205 — Natural History of Treated Neurocysticercosis and Long-Term Outcomes
| Status | Recruiting |
| Phase | N/A |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 500 |
| Study Type | OBSERVATIONAL |
| Conditions | Cysticercosis; Neurocysticercosis |
Neurocysticercosis is a brain disease due to the larval stage of the pork tapeworm (Taenia solium). The most common symptoms patient experience from infection inside the substance of the brain (parenchymal disease) are seizures and headaches. When the infection is either inside the fluid pockets inside the brain (ventricular disease) or in the space around the brain (subarachnoid disease) patie…
NCT00001230 — Host Response to Infection and Treatment in Filarial Diseases
| Status | Recruiting |
| Phase | N/A |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 500 |
| Study Type | OBSERVATIONAL |
| Conditions | Filariasis; Helminthiasis; Parasitic Infection; Mansonelliasis; Onchocerciasis |
| Interventions |
This study will evaluate and treat patients with filarial infections to explore in depth the immunology of the disease, including susceptibility to infection, disease development, and response to treatment. Filarial infections are caused by parasitic worms. The immature worm (larva) is transmitted to a person through a mosquito bite and grows in the human body to 2 to 4 inches in length. Althou…
NCT00001406 — Activation and Function of Eosinophils in Conditions With Blood or Tissue Eosinophilia
| Status | Recruiting |
| Phase | N/A |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 800 |
| Study Type | OBSERVATIONAL |
| Conditions | Immune System Diseases; Eosinophilia; Helminthiasis; Hypersensitivity; Parasitic Disease |
This study will investigate how, why and under what conditions eosinophils (a type of white blood cell) become activated and will examine their function in immune reactions. Eosinophil counts often rise in response to allergies, asthma, and parasitic worm infections. They can also go up in uncommon autoimmune conditions and, rarely, in association with tumors. Elevated levels of these cells is …
NCT00344188 — Diagnosis and Treatment of Leishmania Infections
| Status | Recruiting |
| Phase | N/A |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 289 |
| Study Type | OBSERVATIONAL |
| Conditions | Leishmaniasis; Skin Diseases, Parasitic; Euglenozoa Infections; Parasitic Diseases |
This study will examine the natural history of Leishmanial infections and their treatments. It will provide an opportunity for NIAID staff to learn more about leishmaniasis and perhaps to improve diagnostic tests for these infections. Patients between 2 and 80 years of age with known or suspected leishmaniasis are eligible for this study.
Participants will have routine blood tests and a biopsy…
NCT01168271 — Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
| Status | Recruiting |
| Phase | N/A |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 15000 |
| Study Type | OBSERVATIONAL |
| Conditions | Malaria |
Malaria caused by Plasmodium falciparum continues to be a global problem with devastating consequences. A greater understanding of the immunologic and parasitologic factors associated with infection and disease is badly needed; and will accelerate the development of highly protective vaccines for both mothers and children. Pregnancy malaria is associated with low birth weight, maternal anemia, …
NCT01940757 — Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Baylor College of Medicine |
| Enrollment | 35 |
| Study Type | INTERVENTIONAL |
| Conditions | Hookworm Infection |
| Interventions |
An experimental hookworm infection model is being developed to provide early proof-of-concept that a hookworm vaccine targeting the blood-feeding pathway of adult hookworms is feasible and efficacious. The proposed model consists of vaccinating healthy, hookworm-naïve adults with a candidate hookworm vaccine, followed by challenging them with the investigational product, Necator americanus Larv…
NCT02471378 — Laboratory Evaluation of Pregnancy Malaria Vaccine Candidates/In-vitro Testing of Pregnancy Malaria Vaccine Candidates
| Status | Recruiting |
| Phase | N/A |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 7476 |
| Study Type | OBSERVATIONAL |
| Conditions | Malaria |
Background:
- Malaria is a disease that affects many people in African countries. It is caused by germs that are spread by mosquito bites. It can be fatal if not diagnosed and treated right away. Children younger than 5 and pregnant women are most at risk to get malaria. Researchers want to create a vaccine that will prevent malaria infection during pregnancy.
Objectives:
- To create a vac…
NCT02639299 — Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge
| Status | Recruiting |
| Phase | N/A |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 1500 |
| Study Type | OBSERVATIONAL |
| Conditions | Malaria |
Background:
Malaria is a serious infection caused by a parasite. People get malaria when an infected mosquito bites them. Malaria can cause major health and social problems in places were malaria is common, such as Africa but can also affect travelers who have never been exposed to malaria. Researchers at the NIH want to find a safe and effective malaria vaccine, antimalarial drugs, or prevent…
NCT03937817 — Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
| Status | Recruiting |
| Phase | N/A |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 300 |
| Study Type | OBSERVATIONAL |
| Conditions | Alpha and Beta Thalassemia; Sickle Cell Disease; Malaria; Human Physiology |
Background:
Blood disorders like sickle cell disease and malaria affect many people around the world. Researchers want to learn more about blood disorders. To do this, they need to collect biological samples from people with blood disorders. They also need to collect samples from healthy people.
Objective:
To collect samples to use for research on blood disorders.
Eligibility:
People ages …
NCT05519046 — Cardiac Contractility Modulation in Chagas Heart Disease
| Status | Recruiting |
| Phase | N/A |
| Sponsor | InCor Heart Institute |
| Enrollment | 60 |
| Study Type | INTERVENTIONAL |
| Conditions | Chagas Cardiomyopathy; Heart Failure; Systolic Dysfunction; Right Bundle Branch Block and Left Anterior Fascicular Block; Right Bundle Branch Block and Left Posterior Fascicular Block |
| Interventions | ; |
Chagas disease is an endemic problem in Latin America, where millions of people are chronically infected with T. cruzi. Recently, it was assumed to have clinical and epidemiological relevance in several other countries due to migratory and globalizing social factors. CCC occurs in 30-50% of infected individuals, causing considerable morbidity/mortality rates. Heart failure is the most prevalent…
NCT05478720 — DON in Pediatric Cerebral Malaria
| Status | Recruiting |
| Phase | Phase 1 / Phase 2 |
| Sponsor | Douglas Postels, MD, MS |
| Enrollment | 152 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria, Cerebral |
| Interventions | ; ; |
The goal of this clinical trial is to evaluate the safety of a single intravenous dose of DON in healthy adults, adults with uncomplicated malaria, and children 12 months-14 years old with clinically defined Cerebral Malaria. The main objectives are:
- Evaluate the safety of a single intravenous dose of DON in healthy adults and adults with uncomplicated malaria ( Part 1)
- Determine the safet…
NCT05690841 — FocaL Mass Drug Administration for Vivax Malaria Elimination
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of California, San Francisco |
| Enrollment | 7530 |
| Study Type | INTERVENTIONAL |
| Conditions | Plasmodium Vivax Malaria; Malaria |
| Interventions |
FLAME is an open-label cluster-randomized controlled trial that aims to determine the effectiveness of focal mass drug administration (fMDA) to reduce the incidence of Plasmodium vivax malaria in the Loreto Department in Peru. Standard interventions, including symptomatic and asymptomatic screening for malaria infections, provision of insecticide-treated bednets, and environmental transmission …
NCT06607003 — Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 300 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria |
| Interventions |
Background:
Malaria is a disease caused by parasites transmitted to people by mosquitoes. Around the world, there were 241 million cases and 627,000 deaths from malaria in 2020. Researchers are working to develop vaccines and treatments for this disease.
Objective:
To learn how malaria develops in people; how the body’s immune system reacts to malaria; and how malaria spreads from people to …
NCT06746350 — Feasibility of Integrating Thermotherapy for Treatment of Cutaneous Leishmaniasis in Primary Health Care Setup
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Armauer Hansen Research Institute, Ethiopia |
| Enrollment | 103 |
| Study Type | INTERVENTIONAL |
| Conditions | Cutaneous Leishmaniasis |
| Interventions |
This study will look at how feasible it is to use thermotherapy (TT) as a treatment for skin(cutaneous) leishmaniasis (CL) in health centers in the Sodo and South Sodo districts, Ethiopia. The main questions the investigators want to answer are:
- Is it practical, acceptable, and suitable to use thermotherapy for treating skin leishmaniasis in these health centers?
- How effective is thermothe…
NCT06632600 — A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 130 |
| Study Type | INTERVENTIONAL |
| Conditions | Chagas Disease |
| Interventions | ; ; |
This study is to investigate the ability of LXE408 to clear or reduce the level of parasites in the blood of people with chronic Chagas disease. Participants must have chronic Chagas disease without severe organ dysfunction.
NCT06919614 — STI Testing to Enhance PrEP Use in Pregnancy
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Botswana Harvard AIDS Institute Partnership |
| Enrollment | 600 |
| Study Type | INTERVENTIONAL |
| Conditions | PrEP Adherence; Sexually Transmitted Infections (STIs); Pregnancy |
| Interventions |
The investigators are conducting a study in Botswana to see if offering STI testing along with expanded HIV prevention options (PrEP) helps more pregnant women start and continue using PrEP during and after pregnancy. Pregnant women (n=600) seeking antenatal care in Botswana will be enrolled and randomly assigned to receive the standard of care (standard STI assessment with no STI testing) vers…
NCT07011511 — Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of LAI MMV055 Alone and in Combination With MMV371 in Healthy Participants
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Medicines for Malaria Venture |
| Enrollment | 72 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria, Falciparum |
| Interventions | ; ; |
This is a single-centre, participant- and investigator-blind, randomised, placebo controlled, single ascending dose study to assess the safety, tolerability and PK of a single dose of IM depot injection(s) of LAI formulations of MMV055 administered alone (Part A) and in combination with MMV371 (Part B) in healthy participants.
It is planned to enroll up to 6 sequential cohorts of 8 healthy mal…
NCT05706116 — Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | George Washington University |
| Enrollment | 18 |
| Study Type | INTERVENTIONAL |
| Conditions | Whipworm; Trichuriasis; Controlled Human Infection |
| Interventions |
A Controlled Human Infection Model (CHIM) is being developed to provide early proof-of-concept that experimental infection with the intestinal nematode, Trichuris trichiura, is feasible and safe. The proposed model consists of enrolling consenting, healthy, trichuriasis-naïve adults and challenging them with the investigational product, Trichuris trichiura Egg Inoculum, to assess their ability …
NCT07249463 — Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 96 |
| Study Type | INTERVENTIONAL |
| Conditions | Cryptosporidiosis |
| Interventions | ; ; |
This study has the purpose to demonstrate prospect of benefit of EDI048 on clinical signs and symptoms of cryptosporidiosis to facilitate trial in target population, pediatric patients.
This study aims to investigate the efficacy of a new chemical entity, EDI048, in a controlled human infection model of cryptosporidiosis induced by administration of ABO809 in healthy adults, who become symptom…
NCT07559370 — Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Victoria Biomedical Research Institute |
| Enrollment | 1116 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria (Plasmodium Falciparum) |
| Interventions | ; |
This study is investigating an innovative approach to treating uncomplicated malaria by adding a drug called Imatinib to the current standard of care, Artemether + Lumefantrine (AL). The researchers hope this combination, known as ALIM, will clear infections faster and stop the spread of drug-resistant parasites that are becoming a major threat in Africa
NCT06862453 — Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sanaria Inc. |
| Enrollment | 58 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria Falciparum |
| Interventions | ; ; |
This is a randomized, double-blind, placebo-controlled Phase 1 trial of Plasmodium falciparum (Pf) sporozoite (SPZ) late-arresting replication-competent (LARC) malaria vaccine (PfSPZ-LARC2 Vaccine) administered to healthy, malaria-naive study participants in Germany by direct venous inoculation (DVI) to determine safety, tolerability, and vaccine efficacy (VE) against controlled human malaria i…
NCT07660354 — Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Oystershell NV |
| Enrollment | 98 |
| Study Type | INTERVENTIONAL |
| Conditions | Lice; Head Lice |
| Interventions |
To compare the safety, effectiveness, and preventive benefits of a medical device (X92001483) against Nix Cream Rinse (1% Permethrin) in people with head lice
NCT07385287 — Field Trial of PfSPZ-LARC2 Vaccine in Burkinabe Adults
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sanaria Inc. |
| Enrollment | 180 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria (Plasmodium Falciparum) |
| Interventions | ; |
This is a phase 2 clinical trial of a Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) vaccine (Sanaria® PfSPZ-LARC2 Vaccine) that will assess field efficacy in Africa.
The PfSPZ comprising PfSPZ-LARC2 Vaccine contain a double deletion of the genes encoding the Mei2 and LINUP proteins, both of which are required for transition from liver to bl…
Active, Not Recruiting
NCT04978272 — Modifying Immunity in Children With DihydROartemisinin-Piperaquine (MIC-DroP)
| Status | Active, not recruiting |
| Phase | Phase 3 |
| Sponsor | Grant Dorsey, M.D, Ph.D. |
| Enrollment | 924 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria |
| Interventions | ; |
The MIC-DroP trial will test the hypothesis that preventing early life blood-stage malaria antigenic exposure with intermittent preventive therapy (IPT) enhances protective immunity to malaria. This study will take advantage of a unique opportunity to study infants born to mothers followed in a NIH-funded randomized controlled trial of novel intermittent preventive therapy in pregnancy (IPTp) r…
NCT06735209 — First-in-Human PfSPZ-LARC2 Vaccination/CHMI
| Status | Active, not recruiting |
| Phase | Phase 1 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 22 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria |
| Interventions | ; ; |
This randomized, double-blind, placebo-controlled, Phase 1 trial will enroll up to 22 malaria-naïve, adult participants to test safety, tolerability, immunogenicity, and efficacy of the genetically attenuated Plasmodium falciparum sporozoite vaccine (PfSPZ-LARC2) Vaccine. PfSPZ-LARC2 Vaccine is a late-arresting, replication-competent whole Plasmodium falciparum sporozoite product. We hypothesiz…
Not Yet Recruiting
NCT07646353 — First-in-Human Dose-escalation of GSK4425689A: Safety, Tolerability, and PK in Healthy Adults
| Status | Not yet recruiting |
| Phase | Phase 1 |
| Sponsor | GlaxoSmithKline |
| Enrollment | 40 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria, Falciparum |
| Interventions | ; ; |
This study will assess the safety, tolerability, and pharmacokinetic properties of GSK4425689A monoclonal antibody (mAb) in healthy adults, when administered by either intravenous (IV) or subcutaneous (SC) routes.
NCT07670377 — Drug-Interaction Assessment of GSK3772701 in Healthy Male and Female Participants Aged 18 to 55 Years
| Status | Not yet recruiting |
| Phase | Phase 1 |
| Sponsor | GlaxoSmithKline |
| Enrollment | 20 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria, Falciparum |
| Interventions | ; |
This study aims to evaluate whether GSK3772701 alters the pharmacokinetics (PK) of midazolam (MDZ), a standard probe substrate for the CYP3A4 enzyme. The findings are planned to be used to determine whether GSK3772701 acts as an inducer and/or inhibitor of CYP3A4 and will help guide recommendations for safe co-administration with CYP3A4 substrates.
NCT07430592 — This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax Malaria
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Sponsor | R. Kiplin Guy |
| Enrollment | 104 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria; Malaria Vivax; Radical Cure |
| Interventions | ; ; |
The goal of this Phase 2b study is to examine the safety and efficacy of the combination of SJ733, an investigational agent, and tafenoquine for the radical cure of uncomplicated P. vivax malaria monoinfection in adult participants and determine the contributions of SJ733 to the effect. SJ733 will be administered in a 1-, 2-, or 3-day treatment schedule in combination with a single dose of tafe…
NCT07675785 — PfSPZ-LARC2 Vaccine in Women of Child-bearing Potential (WOCBP) in Mali
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Sponsor | Sanaria Inc. |
| Enrollment | 300 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria (Plasmodium Falciparum) |
| Interventions | ; |
A randomized double blind, placebo-controlled study to assess the safety, tolerability, immunogenicity, and protective efficacy of 1, 6, 29-day PfSPZ-LARC2 Vaccine regimen given at a dose of 2 x10^5 PfSPZ or placebo in healthy WOCBP, who are on pregnancy prevention during vaccination, but report plans to become pregnant in the near future.
Participants will be randomized into two arms. Arm 1:…
NCT07545681 — A Phase 2A Study of a Novel Antimalarial Pyrrolidinamide in Adult Patients With Uncomplicated P. Falciparum Malaria
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Sponsor | GlaxoSmithKline |
| Enrollment | 70 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria, Falciparum |
| Interventions | ; ; |
The study will evaluate the safety and efficacy of a new antimalarial drug GSK3772701 (a pyrrolidinamide), using different doses and treatment durations, in adult participants with uncomplicated Plasmodium (P.) falciparum malaria.
NCT06367361 — One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Sponsor | Universidad Peruana Cayetano Heredia |
| Enrollment | 336 |
| Study Type | INTERVENTIONAL |
| Conditions | Fascioliasis |
| Interventions | ; |
Randomized clinical trial comparing the efficacy and safety of oxfendazole at 20 mg/kg per dose in one and two dose regimens with a two-dose regimen of triclabendazole at 10 mg/kg in an endemic region of the highlands of Peru. Adults with fascioliasis in rural communities will be screened for inclusion and exclusion criteria and a total of 336 subjects (112 per study arm) with chronic Fasciola …
NCT06800248 — Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections
| Status | Not yet recruiting |
| Phase | Phase 3 |
| Sponsor | Swiss Tropical & Public Health Institute |
| Enrollment | 315 |
| Study Type | INTERVENTIONAL |
| Conditions | Trichuris Trichiura; Infection; Hookworm Infection; Ascaris Lumbricoides Infection |
| Interventions | ; ; |
This study aims to assess the efficacy and safety of emodepside compared to mebendazole in adults and adolescents infected with T. trichiura, either as single infection or co-infections with hookworm and/or A. lumbricoides.
NCT06600711 — Nitazoxanide for Treatment of Cryptosporidium in Children
| Status | Not yet recruiting |
| Phase | Phase 3 |
| Sponsor | Johns Hopkins Bloomberg School of Public Health |
| Enrollment | 480 |
| Study Type | INTERVENTIONAL |
| Conditions | Cryptosporidiosis |
| Interventions | ; |
The goal of this clinical trial is to learn if nitazoxanide (NTZ) can treat Cryptosporidium infection in children age 6-12 months. The main questions it aims to answer are:
- Does NTZ treatment of diarrheal Cryptosporidium infection lower the number of days of diarrhea?
- Does NTZ treatment of diarrheal and non-diarrheal Cryptosporidium infection lower the number of days that parasites can be …
NCT07661316 — Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras
| Status | Not yet recruiting |
| Phase | Phase 3 |
| Sponsor | Mundo Sano Foundation |
| Enrollment | 368 |
| Study Type | INTERVENTIONAL |
| Conditions | Trichuriasis; Strongyloidiasis; Ascariasis; Hookworm Infection; Soil-Transmitted Helminthiasis |
| Interventions | ; ; |
The goal of this Phase III clinical trial is to evaluate the efficacy, safety, and acceptability of different treatment regimens for Trichuris trichiura infection in schoolchildren aged 6 to 15 years living in La Moskitia, Honduras, an area with a high burden of soil-transmitted helminth infections.
The main questions it aims to answer are:
- Are combination treatments of albendazole and iver…
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother’s and Baby’s Health
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Bayer |
| Enrollment | 50 |
| Study Type | OBSERVATIONAL |
| Conditions | Chagas Disease |
| Interventions |
This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied.
Chagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later c…
Completed Trials
NCT04706130 — Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | University of Maryland, Baltimore |
| Enrollment | 160 |
| Study Type | INTERVENTIONAL |
| Conditions | Vivax Malaria |
| Interventions | ; |
The study will be an open-labelled randomized clinical trial to determine therapeutic efficacy. Note that this will not be an Investigational New Drug application, as only World Health Organization (WHO)-approved drugs will be used at dosage and for conditions approved.
NCT04230148 — Study of Safety, Tolerability and Clinical Outcomes of Egaten in Fascioliasis Patients (6 Years of Age or Older).
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 301 |
| Study Type | INTERVENTIONAL |
| Conditions | Fascioliasis |
| Interventions |
This is a multicenter, open label, non-comparative, single arm multi-country study in approximately 300 adult and pediatric subjects (≥ 6 years of age) with fascioliasis. The study population consists of male and female adult and pediatric patients (≥ 6 years of age). The study will enroll approximately 300 subjects with acute (minimum 15% of overall study population) or chronic fascioliasis. E…
NCT05874271 — Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea
| Status | Completed |
| Phase | N/A |
| Sponsor | Macfarlane Burnet Institute for Medical Research and Public Health Ltd |
| Enrollment | 794 |
| Study Type | INTERVENTIONAL |
| Conditions | Vivax Malaria; G6PD Deficiency |
| Interventions |
Significant gains have been made in reducing the overall burden of malaria worldwide, however these have been far greater for Plasmodium falciparum than P. vivax.
P. vivax remains a major obstacle to malaria control and elimination efforts, largely due to its ability to form dormant liver stages (hypnozoites) that allows it to escape detection and treatment. Importantly, they are susceptible o…
NCT05891236 — Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults
| Status | Completed |
| Phase | Phase 1 |
| Sponsor | Gates Medical Research Institute |
| Enrollment | 63 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria |
| Interventions | ; ; |
This is a First-in-Human (FiH), randomized, two-part, dose-escalation trial of MAM01 monoclonal antibody (mAb) targeting the Plasmodium falciparum (Pf) Circumsporozoite Protein (CSP). This study will evaluate the safety, tolerability, pharmacokinetics (PK), and protective efficacy of MAM01, as well as safety and PK of repeat subcutaneous (SC) dosing. Part A will have a double-blind, placebo-con…
NCT05875441 — Efficacy and Safety Study of Moxidectin in Adults With Scabies
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | Medicines Development for Global Health |
| Enrollment | 200 |
| Study Type | INTERVENTIONAL |
| Conditions | Scabies |
| Interventions | ; ; |
Moxidectin is not approved to treat scabies in humans. The effective dose of moxidectin to treat scabies is not known. This study aims to assess the efficacy of a single administration of 8 mg, 16 mg, or 32 mg moxidectin per oral in achieving Scabies Complete Cure at Day 28. This study also aims to assess the safety of three strengths of single moxidectin doses in adults with scabies.
NCT05750459 — Pharmacokinetic Study of IV Artesunate to Treat Children With Severe Malaria
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 90 |
| Study Type | INTERVENTIONAL |
| Conditions | Plasmodium Falciparum Infection |
| Interventions |
This clinical study is a phase 4, single-site, open-label pharmacokinetic (PK) study of IV artesunate in up to 100 Ugandan children 6 months-14 years of age who are diagnosed with severe malaria according to standardized World Health Organization (WHO) criteria (any P. falciparum parasitemia and the presence of danger signs). Participants will receive the standard of care IV artesunate for init…
NCT06171113 — A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants
| Status | Completed |
| Phase | Phase 1 |
| Sponsor | GlaxoSmithKline |
| Enrollment | 123 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria, Falciparum |
| Interventions | ; |
The primary purpose of the study is to characterise the safety of GSK4024484 in healthy participants within a controlled pharmacokinetic (PK) range, and the effect of food on the study intervention.
NCT06347471 — The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | Infectious Diseases Research Collaboration, Uganda |
| Enrollment | 160 |
| Study Type | INTERVENTIONAL |
| Conditions | Falciparum; Malaria |
| Interventions | ; |
A prospective study will be carried out in an area where parasites with reduced sensitivity to malaria drugs (artemisinins) have recently emerged. The study will recruit participants from patients who attend the clinic with uncomplicated malaria and asymptomatically infected individuals. Participants are treated with conventional artemisinin-combination therapies (ACT) as part of standard clini…
NCT07033325 — University-Based Chagas Testing in Salta Province, Argentina
| Status | Completed |
| Phase | N/A |
| Sponsor | Mundo Sano Foundation |
| Enrollment | 2568 |
| Study Type | OBSERVATIONAL |
| Conditions | Chagas Disease; Trypanosoma Cruzi Infection; Chronic Chagas Disease |
| Interventions |
The goal of this observational study is to improve access to diagnosis and treatment for chronic Trypanosoma cruzi infection among university students of all ages and genders at the National University of Salta (UNSa), Argentina. The main questions it aims to answer are:
- What is the seroprevalence and geographic distribution of T. cruzi infection in UNSa students?
- Can voluntary point-of-ca…
NCT06408857 — Study To Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in African Population
| Status | Completed |
| Phase | Phase 1 |
| Sponsor | Gates Medical Research Institute |
| Enrollment | 125 |
| Study Type | INTERVENTIONAL |
| Conditions | Healthy Volunteers |
| Interventions | ; ; |
This study will test a new drug (MAM01) to find which doses are safe and could help prevent people from getting malaria for at least 4 months. The study will take place in parts of Africa where malaria is common. Part A is an open-label study conducted in healthy adults whereas Part B is double-blind study conducted in young children and infants. Both the parts will evaluate the safety, tolerab…
NCT06977490 — Human Bioequivalence Study of Amphotericin B Liposome for Injection
| Status | Completed |
| Phase | N/A |
| Sponsor | Sichuan Huiyu Pharmaceutical Co., Ltd |
| Enrollment | 42 |
| Study Type | INTERVENTIONAL |
| Conditions | Invasive Fungal Infections; Neutropenic Fever; Visceral Leishmaniasis |
| Interventions | ; |
Single-center, randomized, open-label, single-dose, two-treatment, two-period, two-sequence crossover design to evaluate the human bioequivalence of two Amphotericin B Liposome for Injection formulations
NCT06983665 — Human Bioequivalence Study of Liposomal Amphotericin B for Injection
| Status | Completed |
| Phase | N/A |
| Sponsor | Sichuan Huiyu Pharmaceutical Co., Ltd |
| Enrollment | 58 |
| Study Type | INTERVENTIONAL |
| Conditions | Invasive Fungal Infections; Neutropenic Fever; Visceral Leishmaniasis |
| Interventions | ; |
A single-center, randomized, open-label, single-dose, two-period, double-crossover study to evaluate the bioequivalence of liposomal amphotericin B for injection (test product) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. compared to the reference product (AmBisome®) in healthy Chinese subjects. Secondary objectives include safety evaluation.
NCT07060508 — L9LS in Women of Childbearing Potential in Mali
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 279 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria |
| Interventions | ; |
Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential (WOCBP) in Mali
NCT07195864 — Retrospective Chart Review of Patients With Acanthamoeba Keratitis Who Have Received 0.8 mg/mL Polihexanide as Part of the “Medicines in Special Situations” (Medicamentos en Situaciones Especiales) Program in Spain.
| Status | Completed |
| Phase | N/A |
| Sponsor | SIFI SpA |
| Enrollment | 23 |
| Study Type | OBSERVATIONAL |
| Conditions | Acanthamoeba Keratitis |
| Interventions |
The study will be a multicentric, retrospective, non-interventional medical chart review of patients with AK who initiated a treatment with 0.8 mg/ml polihexanide as part of the Spanish Medicines in Special Situations program, whether they fully completed the treatment or not.
Baseline date is defined as the date of 0.8 mg/ml polihexanide initiation. The Study Period for each patient will be c…
Other (Suspended)
NCT05652504 — Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1)
| Status | Suspended |
| Phase | Phase 1 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 400 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria |
| Interventions | ; ; |
Background:
Malaria is a disease that affects many people in Africa. It is caused by germs carried by some mosquitoes. A person bitten by an infected mosquito will get malaria. Most malaria infections cause only mild symptoms or none at all, but sometimes the disease can be deadly. Malaria can also harm pregnant women. They may lose their pregnancies or deliver too early, and the mother and ne…