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Showing 1-14 of 14 trials
NCT06838195
The goal of this clinical trial is to evaluate the protective efficacy of S. Flexneri-S. Sonnei bivalent conjugate vaccine against diarrhea caused by Shigella infection in infants and children aged 6 months to 5 years. Researchers will observe the incidence of diarrhea of any severity due to Shigella flexneri and Shigella sonnei infection 30 days after full immunization. The subjects will receive 2 doses of vaccination.
NCT02736968
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.
NCT05156528
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in infants and children aged from 6 months to 5 years.
NCT02445963
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).
NCT03527173
The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the GSK3536852A vaccine, which was designed to protect against shigellosis caused by Shigella sonnei (S. sonnei) and is using the new Generalized Modules for Membrane Antigens (GMMA) platform technology developed by GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH). The study vaccine could be the stepping stone for the development of a multivalent broadly protective Shigella vaccine for vaccination of impoverished communities where shigellosis is endemic. However, a standalone monovalent vaccine against S. sonnei could be used to protect travelers against diarrheal shigellosis, as the vast majority of travelers' shigellosis is caused by S. sonnei, and even to protect infants in endemic regions where shigellosis is primarily caused by S. sonnei. The GSK3536852A vaccine has been tested in two Phase I dose escalation studies in Europe to assess its safety and immunogenicity via three routes of administration: intramuscular (IM), intranasal (IN) and intradermal (ID). The results from the first study (dose escalation with IM vaccination) have shown that the vaccine has an acceptable safety profile and is well-tolerated up to a dose of 100 micrograms (µg). The results from the second study (dose escalation with ID, IN and IM vaccination) showed that GSK3536852A vaccine is well-tolerated also when administered by the ID and IN routes of vaccination. However, immunogenicity data have shown that GSK3536852A vaccine administered by the ID and IN routes is not as immunogenic as GSK3536852A vaccine administered by the IM route. Therefore, it has been decided to proceed with the clinical development program of this vaccine only using the IM vaccination route. In terms of dosage, the regimen tested in Phase I studies (three doses given one month apart) did not show any significant benefit from the third dose in terms of immunogenicity, therefore a two dose schedule was selected for next studies. A Phase IIa study, conducted in endemic regions of Africa (i.e., Kenya), has been completed and confirmed the acceptable safety profile and immunogenicity of GSK3536852A vaccine. Performing this vaccine-human challenge study may give the opportunity to establish evidence of clinical protection induced by the candidate S. sonnei vaccine (GSK3536852A vaccine) at an early development stage.
NCT03491228
Secondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical practice
NCT02280044
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.
NCT03561181
The purpose of this study is to evaluate safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged above 3 Months.
NCT02797236
This is a first-in-human, single-center, single-blinded, observer-masked randomized, dose escalation (two doses), placebo-controlled study in healthy volunteers.
NCT01618591
The purpose of the trial is to develop the evidence on relative efficacy of 3 available single-dose loperamide adjuncted regimens for watery diarrhea and a single-dose regimen, with and without loperamide, for dysentery/febrile diarrhea required for informing decisions among these regimens. Information from this study will be used to develop management guidelines for the diagnosis and management of travelers' diarrhea (TD) among deployed United States and United Kingdom military personnel.
NCT01672580
This project will examine the spread of health interventions with a randomized control trial design by introducing public health interventions in 32 villages in the Honduran Department of Lempira. Based on identified public health needs in the region, namely improved drinking water and diet, this study will provide training on the use of chlorine (sodium hypochlorite) for water purification and multivitamins for nutritional supplementation. In some villages, individuals selected for their social connectedness will be trained and given coupons that can be redeemed for either chlorine bleach or multivitamins, and these persons will be asked to spread this information and distribute coupons to four people of their choosing. In other villages, individuals selected at random will receive the same training, materials, and instructions. A second wave of coupon distribution will provide coupons to those who received a coupon from the original "seed" groups so that they may disperse these coupons further out in the social networks. Over the following months, study investigators will look at how knowledge of these health practices, and uptake or and adherence to the practices, spreads throughout the villages. More specifically, the investigators will examine the speed and extent of spreading of these new health practices after introducing them to three different initial "seed" groups: (1) people chosen on the basis of being named as a friend by many people in their village, (2) people chosen based on being named as a friend by a randomly chosen individual, and (3) a group of randomly chosen individuals. It is hypothesized that spread will occur faster and/or to a greater extent when the intervention is started in groups 1 and 2 versus group 3 (control group).
NCT01638039
The aim of this study is to accelerate the development of vaccine candidates against diarrheal diseases caused by Shigella and Enterotoxigenic Escherichia coli (ETEC). We plan to identify cases of laboratory-proven shigellosis and ETEC-associated diarrhea, to study humoral and cellular immune parameters following natural infections with Shigella and ETEC, and to compare the level of pre-existing local, humoral and cellular immune parameters in cases of shigellosis and ETEC-associated diarrhea and in matched controls.
NCT01612572
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011. It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'. Xiyanping is kind of Chinese Medicine injection used for treating viral pneumonia 、bronchitis、amygdalitis、infantile diarrhea、bacillary dysentery 、virus hepatitis、and Children acute hot diseases in many Chinese hospitals. The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.
NCT01082107
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