Safety and Immunogenicity of Artificial Invaplex (Shigella Flexneri 2a InvaplexAR)
ShigellosisBacillary DysenteryThis 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).
Traveler's Diarrhea (TD) Automated Process
Prevention of Travelers' DiarrheaTo evaluate and compare the immune responses and safety following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or placebo patches.
A Study to Evaluate Safety and Immunogenicity of 1 Booster Dose of 1790GAHB Vaccine in Healthy Adults...
DysenteryBacillaryGVGH Shigella Sonnei 1970GAHB is a vaccine aimed at preventing the disease caused by Shigella sonnei. A post-hoc analysis of subjects who participated in the parent study showed significantly different responses in subjects with detectable versus undetectable antibody titres at baseline, suggesting the possibility that the vaccine might not be sufficiently immunogenic in completely naïve adults. This study was then designed to further characterize the immunogenicity profile of the vaccine and to evaluate whether it was able to induce an immunological memory response.
Solar Disinfection of Drinking Water
DiarrheaDysentery (Bloody Diarrhea)SODISWATER is a European Union funded health impact assessment study investigating the effect of sunlight to inactivate microbial pathogens in drinking water. This study was done by observing whether children younger than 5 years old who drink solar disinfected water were healthier than those who did not. Health was measured by how often the children had diarrhoea. Participants were given plastic bottles to place in the sun, water samples were then collected from these plastic bottles to be analyzed. They were also requested to fill in diarrhea diaries. TESTABLE RESEARCH HYPOTHESES: Health Impact Assessment: Children who use solar disinfected water will have: (a) lower morbidity due to non-bloody diarrhoea and bloody diarrhoea (c) increased growth rates (d) lower mortality (e) increased family productivity (f) decreased care-giver burden (g) increased school attendance
Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea
Travelers' DiarrheaThe study will compare durations of diarrhea among subjects who report to clinic for treatment and who receive either: standard rifaximin therapy at a dose of 200 mg three times a day for 3 days, OR a single 600 mg dose of rifaximin daily for 3 days.
Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study
Travelers' DiarrheaThe purpose of this study is to evaluate the efficacy of the Travelers' Diarrhea Vaccine System to actively immunize against Enterotoxigenic Escherichia coli disease in a field setting.
The Acceptability and Impact of Diarrheal Etiology Prediction (DEP) Algorithm
Diarrhea InfectiousAlgorithms3 moreThis 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.
Results of FilmArray® Gastro-intestinal Panel and Serum Procalcitonin in Acute Colitis and Infectious...
Acute DiarrheaAcute Colitis of Presumed Infectious OriginAcute 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.
Efficacy of Rifaximin in Preventing Campylobacteriosis
DysenteryDiarrhea1 moreThis study is a randomized, double-blinded, placebo-controlled, in-patient trial evaluating the prophylactic efficacy of rifaximin against campylobacteriosis following challenge with C. jejuni.
Safety Study of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above...
DysenteryDysentery1 moreThe purpose of this study is to evaluate safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged above 3 Months.