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Cholera clinical trials

View clinical trials related to Cholera.

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NCT ID: NCT06193408 Recruiting - Cholera Clinical Trials

Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera

Start date: February 11, 2024
Phase: Phase 2
Study type: Interventional

Cholera still remains a global public health concern affecting both children and adults, and patients can succumb in quick time if remain untreated. Cholera is a secretory diarrhea and is generally treated with oral or intravenous rehydration therapy to compensate for the fluid loss. However, antimicrobial treatment is given to patients with moderate to severe diarrhea. The consistent emergence of multidrug-resistant bacteria is a major concern for the management of infectious diseases including cholera. No antisecretory drug has so far been proven successful. In a phase II clinical trial, the investigators will assess the effectiveness of a novel antisecretory drug VR-AD-1005 for treating cholera. Changes in stool volume and rehydration therapy will be assessed for VR-AD-1005 in comparison with placebo. If successful, this will be a huge advance in managing cholera and other secretory diarrhea. The introduction of the antisecretory drug can minimize the hospital stay and reduce antibiotic use, which in turn can reduce the emergence of antibiotic resistance among pathogens

NCT ID: NCT06104345 Recruiting - Cholera Clinical Trials

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

Start date: October 2023
Phase: Phase 4
Study type: Interventional

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®) vaccines or both simultaneously - give blood samples for immunogenicity analyses - participate in adverse event follow up Researchers will compare those receiving only one of the vaccines to those receiving both simultaneously to see if coadministration has an impact on antigen-specific responses measured with: - ELISPOT (plasmablast responses specific to Salmonella typhi, Vibrio Cholerae and Enterotoxigenic Escherichia coli) - ELISA (antibodies in lymphocyte supernatants (ALS) and serum antibodies specific to vaccine antigens)

NCT ID: NCT06003816 Recruiting - Diarrhea Clinical Trials

Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)

Start date: October 18, 2023
Phase: N/A
Study type: Interventional

Objective: The investigators objective is to develop and evaluate the effectiveness of a case area targeted water, sanitation, and hygiene (WASH) intervention in reducing cholera infections and increasing sustained WASH behaviors in transmission hotspots in a ring around cholera cases.

NCT ID: NCT05829772 Recruiting - Cholera Clinical Trials

Impact Study of Cholera Vaccination in Endemic Areas - Seroprevalence

Start date: September 20, 2021
Phase:
Study type: Observational

This project aims to fill this essential knowledge gap by assessing the impact of oral cholera vaccine mass campaigns in 2 sites (urban and rural) in DRC, described in this protocol. The evidence generated from this project will be key to develop future strategies regarding cholera vaccine use in endemic settings, including places with higher burden in terms of cholera mortality

NCT ID: NCT05814042 Recruiting - Diarrhea Clinical Trials

Next Generation ORS: Controlled Trial Comparing ORS With Calcium vs Standard ORS in Reducing Severity of Acute Watery Diarrhea

ORS
Start date: August 21, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Diarrhea remains a leading killer of children in need of better treatments.

NCT ID: NCT05732766 Recruiting - Cholera Clinical Trials

To Evaluate Safety of Oral Cholera Vaccine Hillchol® (BBV131)

Hillchol131
Start date: February 4, 2023
Phase: Phase 3
Study type: Interventional

A Phase III randomized, modified double-blind, multi-centric, comparative study, to evaluate the non-inferiority of immunogenicity and safety of single strain oral cholera vaccine Hillchol® (BBV131) to the comparator vaccine Shanchol™ along with lot-to-lot consistency of Hillchol®(BBV131). Study Population: A total of 1800 participants will be enrolled in three descending age groups(Group I- ≥18, Group II: ≥5 to <18 and Group III: ≥1 to <5). In each group,600 participants will be enrolled and will receive two doses of Hillchol® (BBV131) vaccine two weeks apart.

NCT ID: NCT05657782 Recruiting - Cholera Clinical Trials

First in Human Phase 1 Ascending Dose Study of PanChol in Healthy Volunteers

Start date: December 12, 2022
Phase: Phase 1
Study type: Interventional

This study is a first-in-human, Phase 1 study of the safety, tolerability, and immunogenicity of PanChol in healthy volunteers. There will be three modules in this clinical trial assessing dosing, safety, and immunogenicity: 1. a fixed dose-ranging module, 2. an adaptive dose-finding/optimization module, and 3. a placebo-controlled expansion module.

NCT ID: NCT05559983 Recruiting - Clinical trials for Cholera Vaccination Reaction

Dose Escalation Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Healthy Adults

Start date: December 5, 2022
Phase: Phase 1
Study type: Interventional

This Phase I, first-in-human study is intended to primarily determine the safety of the dose range with or without Aluminum phosphate adjuvant expected to be needed for later clinical studies, to determine the nature of adverse reactions (i.e., safety profile) and to secondly assess the Aluminum phosphate humoral immune responses in non-endemic population to guide future dose selection.

NCT ID: NCT05166850 Recruiting - Cholera Clinical Trials

Preventative Intervention for Cholera for 7 Days

PICHA-7
Start date: December 22, 2021
Phase: N/A
Study type: Interventional

The first objective of our study is to develop a theory-driven evidence-based targeted water, sanitation, and hygiene (WASH) intervention for household members of diarrhea patients in South Kivu, Democratic Republic of the Congo (DRC) through formative research and community engagement. The second objective is to conduct a randomized controlled trial of 2,320 household members of 580 severe diarrhea patients to evaluate the effectiveness of the developed targeted WASH intervention in terms of: 1. reducing diarrheal diseases household members of cholera and severe diarrhea patients; and 2. increasing WASH behaviors.

NCT ID: NCT04853186 Recruiting - Cholera Clinical Trials

Impact Study of Cholera Vaccination in Endemic Areas - Clinical Surveillance

Start date: May 11, 2021
Phase:
Study type: Observational

This project aims to fill this essential knowledge gap by assessing the impact of oral cholera vaccine mass campaigns in 2 sites (urban and rural) in DRC, described in this protocol. The evidence generated from this project will be key to develop future strategies regarding cholera vaccine use in endemic settings, including places with higher burden in terms of cholera mortality.