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Dysentery clinical trials

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NCT ID: NCT05409196 Completed - Clinical trials for Gastrointestinal Disease

Phase 1 Trial for Safety, Tolerability, and Immunogenicity of a Live, Attenuated, Oral Shigella/ETEC Combination Vaccine to Healthy Adults

Start date: September 16, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase 1 dose escalating study to assess the safety, tolerability, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine given orally to healthy European adults 18 to 45 years of age. The major aim is the development of an efficacious and safe vaccine that prevents diarrhea caused by Shigella and ETEC in travelers, military personal visiting endemic countries and children of the developing world. This Phase 1 safety and immunogenicity study used a double-blind, placebo-control design and was conducted in two stages, a single ascending and a multiple ascending stage.

NCT ID: NCT05322694 Completed - Clinical trials for Acute Respiratory Infection

Clinical Decision Rules in the Emergency Department to Improve the Management of Acute Respiratory Infection and Acute Infectious Diarrhea

Start date: February 3, 2022
Phase:
Study type: Observational

Acute respiratory infections (such as influenza-like illness and upper respiratory tract infection) and acute infectious diarrhea are, for the most part, conditions that do not require medical management or specific treatment. Depending on the level of their transmission in the community, however, these diseases place significant clinical and financial burden on the healthcare system, particularly on emergency departments (ED). The investigators propose a prospective multicenter cohort study with which they aim to validate clinical decision rules combining 1) rapid molecular tests and 2) risk stratification tools to identify patients at low risk for complications related to acute respiratory infection and acute infectious diarrhea. The use of these clinical decision rules by nurses in ED triage could allow low-risk patients to be sent directly home for self-treatment without having to see the emergency physician. By eliminating the need for physician assessment, paraclinical testing and prolonged waiting in the ED, these triage-based clinical decision rules could provide a new, safe care pathway for acute respiratory infections and acute infectious diarrhea, reducing the burden on the patient, the healthcare system, and society.

NCT ID: NCT05008640 Completed - Clinical trials for Urinary Tract Infections

Creation of an E-toileting Log Through Classification of the Physical Properties of Stool and Urine Using TrueLoo™

Start date: November 14, 2019
Phase:
Study type: Observational

The purpose of this study is to assess the feasibility of TrueLoo™, an Internet-connected smart toilet seat, in accurately monitoring and logging bowel movements and urinations of residents in senior living facilities across Northern California.

NCT ID: NCT04865497 Completed - Dysentery Clinical Trials

Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old

Start date: January 19, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate immunogenicity and safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.

NCT ID: NCT04602676 Completed - Clinical trials for Decision Support Systems, Clinical

The Acceptability and Impact of Diarrheal Etiology Prediction (DEP) Algorithm

Start date: November 18, 2020
Phase: N/A
Study type: Interventional

This is a randomized crossover study, where clinicians will be randomized to periods where they will use a rehydration calculator application with or without the Diarrheal Etiology Prediction (DEP) algorithm. The crossover will include a washout period to reduce carryover effect. The study will be conducted over a 9-week period. The Investigators will use a random number generator to randomize clinicians to DEP (use of the etiology calculator) or control arm (use of a previously-tested rehydration calculator) within site for the first 4 weeks. After the first 4 weeks, there will be 1-week washout period without decision support, after which each clinician will cross-over to the other arm for the next 4 weeks. The Investigators will enroll diarrhea-treating clinicians who treat children presenting with acute diarrhea at sites in Bangladesh and Mali. Utah investigators will only analyze de-identified data provided by our collaborators in Bangladesh and Mali.

NCT ID: NCT04423159 Completed - Diarrhea Infectious Clinical Trials

Immunological Characteristics of a Population at Risk of Cholera After Oral Cholera Vaccine (CHOVAXIM)

CHOVAXIM
Start date: October 16, 2016
Phase: N/A
Study type: Interventional

The purpose of the study is to find out if individuals who received first and second dose of Oral Cholera Vaccine (OCV) in Lukanga Swamps, Central Province of Zambia have developed protection against future attacks to cholera. The investigators also want to investigate whether vitamin A deficiency and being HIV positive increases the chances of suffering from cholera.

NCT ID: NCT04312906 Completed - Diarrhea Clinical Trials

A Baseline Study in Support of Clinical Evaluation of an Oral Shigella Vaccine Development in Africa

ShigOraVax
Start date: September 14, 2020
Phase:
Study type: Observational

This study aims to address the paucity of accurate incidence data of diarrheal diseases associated with Shigella in Zambia and Burkina Faso. Given the limited feasibility of the current complex diagnostic methods used to detect Shigella in endemic and developing countries due to the costs, the none availability of reagents and a requirement of expensive and complex machinery, we suggest to use a rapide, easy-to-use, cost-effective, and robust Polymerase Chain Reaction (PCR) based rapid tool, the Loop-mediated isothermal amplification (LAMP) based diagnostic assay (ES-RLDT). This baseline study will enable us to generate an accurate estimate of Shigella incidence so as to inform future trials' designs of an oral vaccine development (ShigOraVax) in Burkina Faso and Zambia. This project is part of the EDCTP2 programme supported by the European Union under grant agreement "No RIA2018V-2308

NCT ID: NCT04237181 Completed - Acute Diarrhea Clinical Trials

Results of FilmArray® Gastro-intestinal Panel and Serum Procalcitonin in Acute Colitis and Infectious Diarrhea in the ER

PRODIARRAY
Start date: March 9, 2020
Phase: N/A
Study type: Interventional

Acute diarrhea and acute colitis of infectious origin are common reasons for consultation at the emergency department. The current etiological diagnostic approach is limited to the determination of markers of inflammation, such as CRP and blood leukocytes, which lack specificity and sensitivity for bacterial infection. The stool culture can detect bacterial pathogens in the stool with a result at least 48 hours later and a positivity rate <50%. This study will describe the procalcitonin (PCT) concentrations (a biomarker of bacterial infection) in this population to evaluate its usefulness depending on the viral or bacterial etiology identified by stool multiplex gastro-intestinal PCR panel (GI panel) and stool culture. The investigators hypothesize that PCT levels will be higher if the GI panel or the stool culture identifies a bacteria or a parasite, as it is the case in respiratory tract infections. If there is a detection of a virus by the GI panel or both the stool culture and the GI panel are negative, the investigators expect that PCT values will be lower or negative. the investigators will include the patients admitted to the ED with a suspicion of infectious diarrhea or acute colitis in order to have a large representative panel of infectious diarrhea etiologies. Only the patients having a blood sample prescribed as the routine care will be included. The blood sample is useful for dosing CRP and whole blood cell count (WBC), which are part of current biologic analyses performed in this context. After getting the patient's consent, the investigator will add the PCT dosage in blood sampling and will ask the patient to provide a stool sample, in order to have a stool culture and to perform an extended investigation for the pathogens through multiplex PCR technology (Filmarray ®GI panel). The physician will be asked if all these results (the ones ordered currently together with the dosage of PCT and the GI panel) will change his/her decision to start an antibiotic. Patients will receive a phone call at day 15 after their initial admission in the emergency department and will be asked if he/she has consulted a new physician or if a new treatment by antibiotics was started. Data collection procedures: Data from the medical file will be collected by the investigators and the emergency department clinical research assistant. All the data will be pseudonymized. The collection will be done at the day of admission in the emergency department and after the phone interview at Day15.

NCT ID: NCT03866291 Completed - Clinical trials for Antibiotic Resistant Infection

ESBL in Patients Returning to Sweden With Traveller's Diarrhoea

Start date: February 1, 2017
Phase:
Study type: Observational

Patients with traveller's diarrhoea frequently harbour Extended Spectrum Betalactamase (ESBL)-producing Enterobacteriaceae (EPE) returning from EPE-endemic areas. This study investigates to what extent travellers returning to Sweden with traveller's diarrhoea carry ESBL in their stool. The isolates are examined further according to species, phenotype, antibiogram and whole genome sequencing.

NCT ID: NCT03854929 Completed - Diarrhea Clinical Trials

Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery

CIPAZ
Start date: December 11, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the efficacy of 3 days of azithromycin (AZI) compared to 3 days of ciprofloxacin (CIP) (standard-of-care) for the treatment of children hospitalised with dysentery in Ho Chi Minh City.