Clinical trials: Infectious Diarrhea
Shigellosis
Safety Study of Inactivated Shigella Whole Cell Vaccine in Adults
This is a research study about an experimental (investigational) oral inactivated whole cell Shigella flexneri 2a killed vaccine (Sf2aWC).
- Trial name
- NCT01509846
- Testing
- Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose, Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses, Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses
- Where
- 2 sites in United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- PATH
Shigellosis
A Phase 1, Dose Escalation Study, to Evaluate a New Shigella Sonnei Vaccine in Healthy Adults.
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of 5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) administered by intramuscular route…
- Trial name
- NCT02017899
- Testing
- S. sonnei 1790GAHB
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GSK Vaccines Institute For Global Health S.r.l.
Shigellosis
Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a
In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella…
- Trial name
- NCT02646371
- Testing
- Flexyn2a
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Clostridium Difficile Infection (CDI)
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes.
- Trial name
- NCT03244644
- Testing
- RBX2660, Open label RBX2660 (only for confirmed CDI recurrence)
- Where
- 66 sites in United States, Canada
- Volunteers
- 320 people
- Sponsor
- Rebiotix Inc.
Clostridium Difficile Infection
Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)
606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion.
- Trial name
- NCT01597505
- Testing
- Surotomycin, Vancomycin
- Volunteers
- 606 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Enterotoxigenic Escherichia Coli Infection, Diarrhea
Study Confirming A Human Challenge Model and Investigating The Safety Of VLA1701
This is a single-center, double-blind, placebo-controlled, Phase II vaccination and challenge study designed to confirm a human challenge model with E. coli strain LSN03-016011/A.
- Trial name
- NCT03576183
- Testing
- VLA1701, Challenge Strain
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
Acute Leukemias of Ambiguous Lineage, Bacterial Infection
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant.
- Conditions
- Acute Leukemias of Ambiguous Lineage, Bacterial Infection, Diarrhea, Fungal Infection
- Trial name
- NCT01371656
- Testing
- levofloxacin
- Where
- 84 sites in United States, Canada
- Volunteers
- 624 people
- Sponsor
- Children's Oncology Group
Infectious Diarrhoea
Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea
To assess the safety and the preliminary efficacy data on the three doses of the new Cosmo Technologies oral rifamycin SV colon-release 200 mg tablets manufactured according to MMX technology (CB-01-11) in the treatment of…
- Trial name
- NCT03447821
- Testing
- 400 mg Rifamycin SV dosage, 800 mg Rifamycin SV dosage, 1200 mg Rifamycin SV dosage
- Volunteers
- 40 people
- Sponsor
- Cosmo Technologies Ltd
Diarrhoea
A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants
This study evaluates the immune response and safety of a multicomponent, 2-dose Shigella vaccine in preventing shigellosis in African infants.
- Trial name
- NCT06663436
- Testing
- altSonflex1-2-3 Dose A, altSonflex1-2-3 Dose B, altSonflex1-2-3 Dose C
- Where
- Kenya
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Clostridium Difficile Infection
ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection
Segments 2A and 2B of this trial evaluate the safety, efficacy, pharmacokinetics, fecal concentrations, and fecal microbiome effects of ACX-362E [ibezapolstat] in patients with C. difficile infection (CDI).
- Trial name
- NCT04247542
- Testing
- Ibezapolstat, Vancomycin
- Where
- 29 sites in United States
- Volunteers
- 53 people
- Sponsor
- Acurx Pharmaceuticals Inc.
Dysentery, Shigella
Safety and Efficacy Study of WRSS1, a Shigella Sonnei Vaccine Candidate
This study is an inpatient trial to determine the safety, immunogenicity and efficacy of the WRSS1 candidate vaccine in healthy Thai adult volunteers.
- Conditions
- Dysentery, Shigella, Diarrhea
- Trial name
- NCT01080716
- Testing
- Part 1/Arm 1 of Study: WRSS1 vaccine, Part 2/Arm 1 of Study: S. sonnei 53G, Part 2/Arm 2 of Study: S. sonnei 53G
- Where
- Thailand
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Diarrhea, Respiratory Infection
Micronutrient Sprinkles in a Daycare Center
Diarrheal diseases are a major cause of morbidity and mortality globally in children less than 5 years of age. Prolonged diarrhea, recurrent infections and growth failure in developing countries are usually a consequence of…
- Trial name
- NCT00967551
- Testing
- Micronutrient Sprinkles with zinc, Micronutrient sprinkles without zinc
- Where
- Brazil
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Emory University
Clostridium Difficile Infection
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea
This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT01983683
- Testing
- Cadazolid, Vancomycin
- Volunteers
- 631 people
- Sponsor
- Actelion
Antibiotic-Associated Diarrhea, Clostridium Difficile-Associated Diarrhea
Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to…
- Trial name
- NCT00958308
- Testing
- BIO-K+ CL-1285®
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- Bio-K Plus International Inc.
Diarrhea
Shigella WRSS1 Vaccine Trial in Bangladesh
This is a research study of an experimental (investigational) live attenuated Shigella sonnei vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops an immune response.
- Trial name
- NCT02934178
- Testing
- Shigella sonnei Strain WRSS1 Vaccine
- Where
- Bangladesh
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- PATH
Clostridium Difficile Infection, Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of…
- Conditions
- Clostridium Difficile Infection, Infection, Communicable Diseases
- Trial name
- CD3-OLS (NCT03931941)
- Testing
- RBX2660
- Where
- 51 sites in United States, Canada
- Volunteers
- 793 people
- Sponsor
- Rebiotix Inc.
Clostridium Difficile Infection (CDI)
A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections
Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI.
- Trial name
- NCT02692651
- Testing
- Fidaxomicin, Vancomycin
- Where
- 2 sites in United States
- Volunteers
- 144 people
- Sponsor
- University of Michigan
Shigellosis
Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection
The purpose of this study is to select a safe and immunogenic dose of Invaplex 50 intranasal vaccine, and to assess protection of Invaplex 50 intranasal vaccine against diarrhea, dysentery, and fever following challenge with the…
- Trial name
- NCT00485134
- Testing
- 240 µg Shigella flexneri 2a Invaplex 50 vaccine, 480 µg Shigella flexneri 2a Invaplex 50 vaccine, 690 Shigella flexneri 2a Invaplex 50 vaccine
- Where
- 2 sites in United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Clostridium Difficile Infection Recurrence
A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection
This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy.
- Trial name
- CDI-SCOPE (NCT05831189)
- Testing
- RBX2660
- Where
- 12 sites in United States
- Volunteers
- 41 people
- Sponsor
- Ferring Pharmaceuticals
Healthy
Dose-Finding Study of Lyophilized Shigella Sonnei 53G Challenge Strain
Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for all S. sonnei vaccine candidates.
- Trial name
- NCT02816346
- Testing
- Shigella sonnei 53G
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- PATH