ASSESSMENT OF A NOVEL FIXED DOSE COMBINATION (FDC) DRUG VR-AD-1005 FOR THE TREATMENT OF ACUTE WATERY DIARRHEA IN CHOLERA: A PHASE II, MULTICENTER, RANDOMIZED, PLACEBO CONTROLLED, DOUBLE BLINDED EFFICACY AND SAFETY TRIA
- Conditions
- Digestive SystemAcute watery diarrhea in cholera
- Registration Number
- PACTR202106780884401
- Lead Sponsor
- Vanessa Research Holdings Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
•Signed informed consent.
•Adults, both genders aged 18-55 years
•Acute is mild to severe watery diarrhea (defined as the passage of three or more liquid stools within the 24 hours before admission, WHO severity assessment criteria. Diarrhea is defined as severe if the patient is passing over 8 liters of stool per day, as moderate if stool output is between 3 and 8 liters per day and as mild if the patient is passing less than 3 liters of stool per day).
•Confirmation of cholera detection of cholera by rapid detection test (RDT), followed by confirmation via culture or RT-PCR (as available).
•Known or suspected hypersensitivity to trial product(s) or related products
•Subjects with the passage of bloody stools or purulent stools
•Subjects with chronic diarrhea
•Clinically significant concomitant systemic disease (i.e. heart failure, acute kidney injury, sepsis or life-threatening malignant cancer)
•Subjects suffering from CV abnormalities.
•Mental incapacity, unwillingness, or language barriers, precluding adequate understanding or cooperation.
•History of receiving antimicrobial or antidiarrheal drugs prior to admission.
•Positive urine pregnancy test for all female patients
•Failure to obtain informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Reduction in stool output volume (ml/hour) over a treatment period measured and plotted as total stool output during 12-hour stool collection every 12 hours fo120 hours.<br>
- Secondary Outcome Measures
Name Time Method