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Dysentery clinical trials

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NCT ID: NCT03012048 Active, not recruiting - Clinical trials for Environmental Exposure

Effectiveness of Point-of-use Water Treatment Technologies to Prevent Stunting Among Children in South Africa

Start date: June 2016
Phase: N/A
Study type: Interventional

This project is a community-based randomized controlled trial designed to test the effectiveness of two point-of-use water treatment technologies to improve clean drinking water access, reduce enteropathogen burden, and improve child growth among children in Limpopo, South Africa.

NCT ID: NCT02920242 Terminated - Travelers' Diarrhea Clinical Trials

A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.

Start date: December 15, 2016
Phase: Phase 3
Study type: Interventional

This study compared safety and efficacy of a generic rifaximin tablet to the reference listed drug in the treatment of travelers' diarrhea. Additionally both the generic and reference formulations were tested for superiority against a placebo tablet. It was planned that 450 patients would be enrolled, but only 28 patients were randomized. Of these, 1 patient discontinued due to failure to meet the inclusion/exclusion criteria. The remaining 27 patients received study drug and 25 patients completed the study. The study was terminated due to slow enrolment. The final analysis included only safety analysis in the Safety population, due to the low number of randomized patients. No efficacy analysis was performed.

NCT ID: NCT02866201 Completed - Clinical trials for Traveler's Diarrhoea

Etiological Diagnosis of Traveler's Diarrhoea

DIAVOY
Start date: September 15, 2013
Phase: N/A
Study type: Interventional

Traveler's diarrhoea or turista is the most common disease in travelers. It has been reported based on studies in 20 to 60% of travelers, depending among other conditions and travel destinations. Currently, less than 30% of the etiology of diarrhoea is identified by bacteriological v,irological and parasitology traditional techniques. This ignorance of the diarrhoea etiology causes difficulties in the establishment of a specific and rapid management in this extremely common condition and having a significant cost to society. Technological advances in laboratory diagnosis, such as quantitative real-time Polymerase Chain Reaction (PCR), can allow us now to improve the etiological diagnosis of traveler's diarrhoea using simple rectal swabs. So, the principal objective of this study is to assess the efficacy of a new diagnosis strategy in order to establissh the etiological diagnosis of traveler's diarrhoea. The hypothesis consists in improving the number of patients with a confirmed etiological diagnosis of traveler's diarrhoea by 5%.

NCT ID: NCT02797236 Completed - Shigellosis Clinical Trials

SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers

Start date: September 2016
Phase: Phase 1
Study type: Interventional

This is a first-in-human, single-center, single-blinded, observer-masked randomized, dose escalation (two doses), placebo-controlled study in healthy volunteers.

NCT ID: NCT02736968 Completed - Giardiasis Clinical Trials

Auranofin for Giardia Protozoa

Start date: November 6, 2016
Phase: Phase 2
Study type: Interventional

This is a phase IIa, randomized, placebo-controlled, single-blinded superiority treatment study in males and non-pregnant females, 18 to 65 years of age who are in good health. This study is designed to compare placebo to once daily doses of 6mg auranofin for adults with amebiasis or giardiasis. A sample size of 68 subjects enrolled with amebiasis (34 per arm) and 68 with giardiasis (34 per arm); Power based on 60 subjects with amebiasis and 60 with giardiasis completing the study.Eligible subjects will be randomly assigned to a treatment group with auranofin (6 mg orally once daily for 5 days for giardiasis or 7 days for amebiasis) compared to a placebo group receiving similar but not identical placebo capsules. Projected duration of subject participation will be approximately 30 days of face to face visits, including the pre-enrollment screening period of up to 4 days. It is anticipated that it will take approximately 3.5 years to finish the study. Primary objectives are: 1) to compare the proportion of subjects with stools positive by rapid Enzyme Immunoassay (EIA) and positive antigen detection EIA for E. histolytica at enrollment with resolution of diarrhea (less than 3 loose stools/24 hrs) by Day 7 for E. histolytica infections. 2) to compare the proportion of subjects with stools positive by rapid EIA and positive antigen detection EIA for Giardia at enrollment with resolution of diarrhea (less than 3 loose stools/24 hrs) by Day 5 for Giardia infections.

NCT ID: NCT02736539 Withdrawn - Traveler's Diarrhea Clinical Trials

Clinical Trial of CBS-2004 in Prevention of Travelers' Diarrhea

Start date: April 15, 2017
Phase: Phase 3
Study type: Interventional

This study is designed as a randomized double-blinded treatment trial among travelers' to geographical areas with moderate-severe rates of traveler's diarrhea. Travelers will be randomized to receive CBS 2004 or masked placebo to be taken daily while traveling. The test article or placebo will be taken starting 7 days prior to travel.

NCT ID: NCT02498301 Completed - Travelers' Diarrhea Clinical Trials

Trial Evaluating Chemoprophylaxis Against Travelers' Diarrhea - Prevent TD

Start date: November 10, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to develop evidence on the relative efficacy of 2 rifaximin chemoprophylaxis regimens for the prevention of Travelers' Diarrhea (TD) in a deployed setting. An additional purpose is to explore the effect of chemoprophylaxis on microbial flora and antimicrobial resistance, and obtain parameter estimates to inform a cost-effectiveness model of chemoprophylaxis in prevention of TD. Information from this study will be used to develop management guidelines for the prevention of TD among deployed (United States (US) and United Kingdom (UK) military personnel. The study will be a multi-site, randomized, placebo-controlled, double-blind, clinical trial among deployed military personnel. The study will test 2 TD chemoprophylaxis regimens (once daily versus twice daily) of the same antibiotic, rifaximin, compared to a placebo. For the proposed chemoprophylaxis study described herein, cohorts of military personnel (US and UK) deploying/traveling overseas will be recruited prior to travel to participate and will undergo enrollment procedures as outlined in study appendices. Subjects who are eligible and agree to participate will be randomized to receive one of 3 regimens: (1) rifaximin 550 mg daily; (2) rifaximin 550 mg twice a day; or (3) placebo, to be taken while deployed. Chemoprophylaxis will be maintained for duration of travel or a predetermined period of up to 6 weeks and at least 2 weeks, which may include a period of up to 5 days of use after return to COO for deployments less than 6 weeks in duration. Clinical and laboratory data will be obtained before, during if available and after deployment/chemoprophylaxis.

NCT ID: NCT02445963 Completed - Shigellosis Clinical Trials

Safety and Immunogenicity of Artificial Invaplex (Shigella Flexneri 2a InvaplexAR)

Start date: October 1, 2015
Phase: Phase 1
Study type: Interventional

This study is an open-label, dose-escalating Phase 1 investigation of S. flexneri 2a InvaplexAR vaccine. A total of up to 40 subjects will receive one of four S. flexneri 2a InvaplexAR vaccine doses. The vaccine will be administered intranasally (without adjuvant).

NCT ID: NCT02291575 Completed - Asthma Clinical Trials

Improving the Quality of Private Sector Health Care in West Bengal

Start date: October 2012
Phase: N/A
Study type: Interventional

The rural healthcare market in much of the developing world is composed largely of informal private providers. These private providers often have little to no certifiable medical training. Recent studies in India using medical vignettes (or hypothetical medical situations) to measure clinical competence and direct observations of doctor-patient interactions to measure clinical practice highlight the poor quality of care that most patients receiveā€”a problem that is clearly relevant beyond India and affects most low-income countries worldwide. For instance: 1. In rural India, standardized patients presenting with chest pain and (on further questioning) radiating pain in the arm are (correctly) diagnosed with a heart attack in less than 25 percent of cases. 2. Across 8 low and middle-income countries, health care providers completed the four necessary vital statistics for new patients in less than 4 percent of interactions: health care providers in the public sectors of many developing countries routinely spend less than 1 minute per patient. To address these deplorably low standards in both medical knowledge and practice, the Liver Foundation in Kolkata has been working with private rural health care providers through capacity building activities to improve quality in the private sector. The program consists of multiple-week training to private rural health care providers on the basis of a well-developed curriculum in the district of Birbhum, West Bengal. This study aims to assess the impact of this training program using a randomized evaluation, in which providers are randomly assigned to the treatment, i.e. the Liver Foundation's training program, or the control, i.e. no such training. As an independent outside evaluation team, we will run a baseline survey for all providers (through a third party data collection agency), monitor the application of and compliance in the Liver Foundation's training intervention, and conduct a final endline study. By comparing the treatment and control groups on a variety of measures developed to capture competence in provider knowledge and practice, we can rigorously assess whether such a training program for informal rural health care providers is an effective means of improving provider medical knowledge and practice in the short run. It is worth noting that this study will not be able to capture long run effects , such as price or location changes, on health care for the rural poor.

NCT ID: NCT02280044 Completed - Diarrhea Clinical Trials

Efficacy of Rifaximin in Preventing Campylobacteriosis

Start date: October 2014
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a randomized, double-blinded, placebo-controlled, in-patient trial evaluating the prophylactic efficacy of rifaximin against campylobacteriosis following challenge with C. jejuni.