Clinical Trials for Salmonella Infections

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 Salmonella Infections from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 6
• Active, not recruiting: 5
• Completed: 31
• Other: 8

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT03971669 — Blood Donor CVD 5000

This is an open-label, non-randomized study. Volunteers will be vaccinated with the typhoid oral vaccine, Vivotif. Vivotif has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood, saliva, and stool specimens over a follow-up time period of up to eight years. The specimens obtained in this clinical research…

NCT04878549 — Transcriptomic Responses for the Identification of Pathogens

Acute undifferentiated febrile infection (AUFI) is a common presenting syndrome in low-resource settings and better diagnostics are urgently needed to improve patient management and guide disease prevention interventions. Assessment of the host gene expression response to infection in endemic populations has demonstrated significant promise as a new approach to identifying patients with enteric…

NCT07314281 — Meropenem vs Azithromycin Efficacy in Case XDR Enteric Fever

1. Primary Objective:

   o To evaluate the efficacy of intravenous azithromycin compared with meropenem in the treatment of extensively drug-resistant (XDR) enteric fever.

2. Secondary Objectives:

   • To evaluate the fever defervescence and Salmonella Typhi eradication
   • To evaluate the cost-effectiveness of intravenous azithromycin versus meropenem in treating XDR enteric fever.

3. Explo…

NCT07416461 — Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-typhoidal Salmonella Disease

The goal of this observational study is to learn about the impact of malaria vaccination on the risk of invasive non-typhoidal Salmonella disease in children below the age of 5. Eligible participants residing in the Kisantu Health Zone (DRC) and presenting fever are enrolled in healthcare facilities and tested for malaria and iNTS. Using a case-control (test-negative) design, the researchers wi…

NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective

RACSMEI addresses the high burden of infectious diseases in low- and middle-income countries, including Cambodia, where limited surveillance and laboratory capacity often obscure etiologies and transmission dynamics. This knowledge gap hinders the design of effective prevention and control strategies.

RACSMEI will improve understanding across multiple pathogens using a multidisciplinary One He…

NCT07286370 — A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants

The purpose of this study is to evaluate the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate (iNTS-TCV) vaccine in infants with the first dose administered at 6 months of age (MOA) or 6 weeks of age (WOA).

Active, Not Recruiting

NCT03299426 — Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi

This study will evaluate the efficacy of a Typhoid conjugate vaccine (Vi-TCV) in Malawi, Africa among children age 9 months through 12 years. Participants will be randomized in a 1:1 ration to receive the study vaccine or the control vaccine (meningococcal group A conjugate vaccine - MCV-A).

NCT04083950 — Induction of Gut Permeability by an Oral Vaccine

This study evaluates the effect of an oral typhoid vaccine on disruption of the intestinal barrier and response of the immune system. Intestinal and whole-body responses will be measured in all participants before and after the vaccine.

NCT04694235 — Egg Intervention During Pregnancy in Indonesia

The study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers. it aims to assess the effectiveness of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes (growth and development) in infants, who will be followed up until 24 months old

NCT05870150 — Challenge Non-Typhoidal Salmonella (CHANTS) Study

This protocol describes the challenge non-typhoidal Salmonella (CHANTS) study. This is a first-in-human phase 1, double-blinded, randomised, dose-escalation human infection study, conducted in healthy volunteers aged 18 to 50 years. The primary objective of the study is to perform a dose escalation with two strains (ST19 or ST313) to determine the infectious dose required for 60-75% of voluntee…

NCT06213506 — A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants

The purpose of this study is to evaluate the safety, reactogenicity, and immune response of the GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-generalized modules for membrane antigens (iNTS-GMMA) candidate vaccine against S. Typhimurium and S. Enteritidis with an age de-escalation and dose escalation approach in African population, starting w…

Not Yet Recruiting

NCT06757283 — ZyVac-TCV Bangladesh Study

This is a prospective closed cohort, open-label, phase III effectiveness study using a test-negative design of a typhoid conjugate vaccine, ZyVac® TCV (purified Vi capsular polysaccharide of Salmonella Typhi conjugated to tetanus toxoid as carrier protein), manufactured by Zydus Lifesciences Limited. The study will be conducted in a closed cohort population among children aged 6 months to 15 ye…

NCT07663032 — A Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GSK Vaccines Institute for Global Health (GVGH) Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Young Adults

The current clinical study will evaluate the GVGH Quadrivalent Pan-Salmonella vaccine for the first time in healthy adults in Africa. The purpose of the current Phase 1 study is to evaluate the safety, reactogenicity, and the immune response induced by the Pan-Salmonella vaccine.

NCT07641348 — COMPARISON OF SINGLE VERSUS COMBINATION DRUG THERAPY IN EXTENSIVELY DRUG RESISTANT SALMONELLA TYPHI IN TERMS OF TIME TO DEFERVESCENCE

This randomized controlled trial will compare the effectiveness of single-drug therapy (meropenem) versus combination therapy (meropenem plus azithromycin) in children aged 2-16 years diagnosed with extensively drug-resistant (XDR) typhoid fever at the Children’s Hospital, Lahore. A total of 94 patients will be enrolled and randomly assigned to either treatment group. The primary outcome is tim…

Completed Trials

NCT00000868 — A Study to Evaluate the Safety and Effectiveness of HIV-1 LAI gp120 (an HIV Vaccine) Given With or Without HIV-1 MN rgp120 (Another HIV Vaccine) to HIV-Negative Volunteers

The purpose of this study is to evaluate the safety and effectiveness of giving healthy volunteers a new oral HIV vaccine which has been incorporated into a bacterial cell. This oral vaccine (HIV-1 LAI gp120) will be given with or without a different injected HIV vaccine (HIV-1 MN rgp120).

Vaccines are preparations that are introduced into the body to try to prevent infection or create resista…

NCT00679172 — Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults

This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility. The vaccine will be delivered as a single oral dose to healthy, typhoid vaccine-naïve adults.

NCT01405521 — Understanding Typhoid Disease After Vaccination

Using an established model of human typhoid infection, whereby healthy adults are deliberately infected with typhoid-causing bacteria, the investigators will determine how effective a new oral typhoid vaccine (M01ZH09) is in preventing infection. A previously licensed oral typhoid vaccine (Ty21a) will be used to make sure the challenge model used works properly.

NCT02947295 — Global Genomic and Proteomic Profiling of African Children With Typhoid Fever

To develop a rapid, sensitive, and inexpensive diagnostic method, as well as more efficacious vaccine, for countries where typhoid fever remains a major public health burden.

NCT02100397 — Understanding Paratyphoid Infection

Enteric fever is responsible for over 20 million illnesses and 200,000 deaths each year. S. Paratyphi A accounts for a substantial and increasing proportion of these cases, as high as 90% in some regions of Asia. There are currently no vaccines directed against S. Paratyphi A, although there some candidates in preclinical and phase 1 trials. This study is funded by the European Vaccine Initiati…

NCT02192008 — Investigating Enteric Fever - Salmonella Typhi and Paratyphi Challenge Study

Enteric fever, an infection characterised by diarrhoea and rash, is most often caused by a bacteria called Salmonella enterica. After ingesting contaminated food or drink, the Salmonellae travel first to the gut, then the bloodstream, from where they can infect other parts of the body. Antibiotics are used to kill the bacteria, but with increasing rates of antibiotic resistance, this treatment …

NCT02391909 — Phase 4 Study To Assess The Safety Of Vivotif At Different Release Titers Among Travelers

This is a multicenter (at travel clinics), phase 4 observational prospective cohort study in healthy adult male and female travelers for whom typhoid vaccination with Vivotif is recommended, as per standard practice.

NCT02324751 — Vaccines Against Salmonella Typhi

Using an established model of human typhoid infection, whereby healthy adults are deliberately exposed to typhoid-causing bacteria, the investigators will determine how effective a new typhoid conjugate vaccine (Vi-TCV) is in preventing infection. The new typhoid vaccine will be compared with a control vaccine (meningococcal ACWY). The protective effect of a currently used typhoid polysaccharid…

NCT02773407 — Nepal Undifferentiated Febrile Illness Trial

The purpose of the study is to determine whether azithromycin or cotrimoxazole is the best empirical treatment for undifferentiated febrile illness in Nepal

NCT03312699 — Effects of Aging on Primary and Secondary Vaccine Responses

The purpose of this study is to use an existing, unique clinical cohort: the longitudinal cohort of younger (21-40 years) and elderly (>65 years) subjects whose yearly influenza vaccine responses have been studied extensively since 2007, to gain molecular and cellular mechanistic insights into the impaired vaccine responses in the elderly.

NCT03554213 — Typhoid Conjugate Vaccine Introduction in Navi Mumbai, India

The purpose of this study is to evaluate the impact of a government-led typhoid conjugate vaccine introduction program on typhoid disease burden in Navi Mumbai, India.

NCT03614533 — Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso

Typhoid fever is an illness that may cause mild effects in children, such as fever and feeling tired, or it may cause serious effects– even death. A new typhoid vaccine has recently been recommended by the World Health Organization (WHO) to prevent typhoid in children. But this new typhoid vaccine has not been tested with all of the vaccines given to children in Burkina Faso. The investigators…

NCT03889067 — Understanding How Salmonella Typhi Infects Humans (Bottlenecks)

Typhoid fever is an infection caused by the bacteria Salmonella Typhi (S. Typhi). S. Typhi causes disease principally in developing countries where communities do not have access to safe water or adequate sanitation. It is thought to cause illness in approximately 22 million people every year and up to 200,000 deaths, mostly in children. The bacteria are spread when faeces from infected individ…

NCT04349553 — Study to Evaluate the Safety, Tolerability and Immunogenicity of a Potential Enteric Fever Vaccine

A Phase 1, randomised, double-blind, placebo-controlled, parallel group study in 45 healthy participants aged 18 to 45 years inclusive.

NCT04830371 — Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants

This is an observer-blinded, comparative, single dose, clinical phase II/III study to assess the immunogenicity and safety of EuTCV compared to Typhoid conjugate vaccine in healthy Filipino participants aged 6 months to 45 years.

NCT04801602 — Commercial Typhoid Tests Validation Trial

Typhoid fever (typhoid) is an enteric bacterial infection caused by Salmonella enterica serovar Typhi (Salmonella Typhi; S. Typhi). It is one of the most common bacterial causes of acute febrile illness in the developing world, with an estimated 10.9 million new cases worldwide and 116.8 thousand deaths in 2017. Like many febrile illnesses, typhoid presents with non-specific symptoms and signs,…

NCT04289688 — Health Itinerary of Young Children With Suspected Bloodstream Infection in Kisantu General Referral Hospital, DR Congo

Bloodstream infections are frequent in children admitted to the hospital for severe febrile illness in sub-Saharan Africa.Ongoing blood culture surveillance at Kisantu Hospital showed non-typhoidal Salmonella (NTS) as the first cause of bloodstream infections in children. Bloodstream infections have a high case fatality (15 - 20%). Outcome of bloodstream infections is dependent on timely diagno…

NCT04473768 — Clinical Decision Support in Non-typhoidal Salmonella Bloodstream Infections in Children

In sub-Saharan Africa, non-typhoidal Salmonella (NTS) are a frequent cause of bloodstream infection, display high levels of antibiotic resistance and have a high case fatality rate (15%). In Kisantu hospital in the Democratic Republic of Congo (DR Congo), NTS account for 75% of bloodstream infection in children and many children are co-infected with Plasmodium falciparum (Pf) malaria. NTS blood…

NCT04349826 — The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial)

Typhoid and paratyphoid (enteric) fever affects more than 11 million children and adults globally each year including 7 million in South Asia. Up to 1% of patients who get typhoid may die of the disease and, in those that survive, a prolonged period of ill health and catastrophic financial cost to the family may follow. In the last 20 years, treatment of typhoid fever with a 7-day course of a s…

NCT04850677 — Treating Non-typhoidal Salmonella Bloodstream Infections in Children Under Five in DR Congo: a Cohort Study

With this study the researchers aim to provide observational data on the treatment efficacy of currently used antibiotic treatment regimens for NTS BSI in hospital-admitted children. The study is an observational cohort study where the antibiotic treatments used and treatment outcomes in the St. Luc general referral hospital in Kisantu health zone (Province Kongo Central, DR Congo) will be desc…

NCT05475379 — Non-inferiority Trial of Locally Manufactured Typhoid Conjugate Vaccine ‘Typhocon’ in Bangladesh

This is a double blinded, randomized-controlled, non-inferiority trial of a typhoid conjugate vaccine, Typhocon (Vi- polysaccharide conjugated to diphtheria toxoid, Vi-DT), manufactured by a local company, Incepta Vaccine Limited. The vaccine will be tested among individuals from 6 months to 60 years of age residing in Mirpur area of Dhaka city. The Typbar-TCV (Vi-polysaccharide conjugated to t…

NCT05480800 — A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever

The purpose of this study is to assess the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate (iNTS-TCV) candidate vaccine to be administered for the first time in humans. The study intervention will be evaluated in European adults in Stage 1 (a 2-step stag…

NCT05579821 — Evaluation Study of DPP® Typhoid Assay

Fever management is a major problem in Low and Middle Income Countries (LMICs) where access to good quality diagnostic test is often unavailable. Fever due to typhoid is similar to other undifferentiated febrile illnesses and typhoid can be mistaken with other vector borne febrile illnesses such as scrub typhus. Currently available diagnostic tests, blood and bone marrow culture, and RDTs have …

NCT04543877 — WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study

The purpose of this study is to determine if adding dietary fiber, such as inulin, to a diet that does not have enough fiber would raise the levels of potentially beneficial bacteria, such as Bifidobacterium, in the gut. There is evidence to suggest that these microbes can affect gut health and immune response, including to vaccines. The investigators will examine how inulin in the diet (compar…

NCT05613205 — Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults

A bivalent Typhoid and Paratyphoid A conjugate investigational vaccine aimed to prevent both typhoid and paratyphoid enteric fever in infants and older age groups has been developed by GlaxoSmithKline (GSK).

The purpose of this first-time-in-human study is to evaluate the safety and immunogenicity profile of a low and a full dose of the investigational vaccine, formulated with or without adjuv…

NCT05500482 — Vellore Typhoid Vaccine Impact Trial

This cluster randomised trial will examine the impact of introducing TyphiBEV, a typhoid conjugate vaccine licensed in India, on the incidence of typhoid fever in a high burden urban setting in South India.

NCT06546982 — Diagnosis and Staging of Typhoid Fever Using Surface-enhanced Raman Spectroscopy Liquid Biopsy

The goal of this project is to adapt the gold nanoparticle-based surface-enhanced Raman spectroscopy (SERS) technology to clinical application. In this exploratory study a measurement protocol will be established to subsequently investigate whether SERS allows to diagnose patients infected with typhoid fever as well as to stage the disease.

NCT06104345 — Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Cholera (Dukoral®) Vaccines

The goal of this clinical trial is to explore the coadministration of oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines in healthy volunteers aged 18-65 years. The main question it aims to answer is:

• Does coadministration impact the immune responses to Vivotif® and Dukoral® vaccines

Participants will:

• receive either oral typhoid fever (Vivotif®) or oral cholera (Dukoral®) vac…

NCT07624175 — Immunogenicity and Tolerability of Booster Typhoid Conjugate Vaccine (TCV) 5-6 Years After Initial Dose in Children in Burkina Faso

This study evaluated the persistence of immunity following primary typhoid conjugate vaccination in early childhood and assessed the immunogenicity and safety of a booster dose administered 5-6 years later. Children previously enrolled in a Phase 2 randomized clinical trial of Vi-tetanus toxoid conjugate vaccine (Vi-TT) were re-enrolled at 6-7 years of age. Participants who previously received …

NCT07150065 — Efficacy of Levofloxacin Versus Ciprofloxacin in the Treatment of Childhood Typhoid Fever

Sample size of 360 children with typhoid fever were enrolled and randomly divided in two groups. All the children were enrolled in the trial from Pediatrics emergency. Informed consent was obtained from parents. Demographics (name, age of child, sex of the child, duration of fever, weight, season, socioeconomic status and residence) were noted. Then children were admitted and randomly divided i…

NCT07445282 — This Randomized Controlled Trial Evaluates the Comparative Efficacy of Intravenous Meropenem Alone Versus Intravenous Meropenem Combined With Oral Azithromycin in Children Aged 6 Months to Under 5 Years Diagnosed With Blood Culture-confirmed Extensively Drug-resistant Uncomplicated Typhoid Fever

This randomized controlled trial evaluates the comparative efficacy of intravenous meropenem alone versus intravenous meropenem combined with oral azithromycin in children aged 6 months to under 5 years diagnosed with blood culture-confirmed extensively drug-resistant uncomplicated typhoid fever. A total of 90 participants are randomly assigned in a 1:1 ratio to receive either meropenem monothe…

Other (Unknown)

NCT03067961 — Investigating Typhoid Fever Pathogenesis

Typhoid fever results from infection with a bacterium called Salmonella Typhi and is a major cause of illness worldwide. It is estimated to infect 20-25 million people every year and can affect people of all ages, but is particularly common in young children. The disease is spread through contaminated food and water, and efforts to improve water quality, sanitation and hygiene will likely go a …

NCT05562102 — TyVECO: Surveillance Protocol

In Kisantu Health Zone, approximate population 200,000, fever surveillance will be implemented in 8 health centers and 1 tertiary hospital. Individuals presenting to one of these study facilities with acute fever or history of fever or individuals presenting with suspicion of intestinal perforation irrespective of fever status, will be considered for enrollment. Following consent, blood samples…

NCT04852185 — Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana

A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA) with a primary endpoint of determining the total protection conferred by single-dose vaccination with Vi-TT against blood culture-confirmed symptomatic S. Typhi infection in the intervention vaccine clusters, compared…

NCT05119426 — Effectiveness of a Typhoid Conjugate Vaccine in DRC

This is a prospective cohort evaluation of vaccine effectiveness of a single dose of Typbar-TCV® against symptomatic blood culture-confirmed typhoid fever when administered through a mass vaccination campaign to children 9 months to <16 years of age in Kisantu, DRC.

NCT05771779 — Co-administration Study of OCV, TCV and MR

An open-label, randomized controlled, non-inferiority study of co-administration of OCV, TCV and MR vaccines among children 12 to 59 months of age in Dhaka, Bangladesh will be conducted. Children who did not receive any of the aforementioned vaccines will be included in the study.

This study will be conducted among 2117 children of 12-59 months of age residing in Mirpur area (wards 4, and 6-16…