Digestive System Acute watery diarrhea in cholera
Conditions
Interventions
Placebo
VRAD1005
Sponsors
Vanessa Research Holdings Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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).
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Time until the stool volume output of 200mL/hour or less. Duration of stool output in excess of 200mL/hour per patient will be recorded between the start and end of the treatment for both treatment groups. • Time until recovery. Duration of diarrhea until the passage of first non-watery stool or no stool for 12 hours or the end of treatment (120 hours) will be derived from date and time records in daily stool charts. • Number of recovered subjects within the treatment group. The number of recovered subjects will be recorded as total for the entire treatment duration, and as the number of recoveries per each 24-hour period of treatment. • Number of unscheduled IV rehydration episodes per treatment. The number of unscheduled IV rehydration episodes per treatment will be recorded for the entire duration of the treatment. • Duration of IV rehydration for the entire treatment period per treatment group and per each 24-hour period of treatment. • Safety will be measured by the proportion of patients that will present with AE following administration of VR-AD-1005. | — |
Countries
Ghana
Contacts
Public ContactApatu Nana Abena Kwaa
GHS ERC Administrator
Outcome results
None listed