Cholera still remains a global public health concern affecting both children and adults, and patients can succumb in quick time if remain untreated. Cholera is a secretory diarrhea and is generally treated with oral or intravenous rehydration therapy to compensate for the fluid loss. However, antimicrobial treatment is given to patients with moderate to severe diarrhea. The consistent emergence of multidrug-resistant bacteria is a major concern for the management of infectious diseases including cholera. No antisecretory drug has so far been proven successful. In a phase II clinical trial, the investigators will assess the effectiveness of a novel antisecretory drug VR-AD-1005 for treating cholera. Changes in stool volume and rehydration therapy will be assessed for VR-AD-1005 in comparison with placebo. If successful, this will be a huge advance in managing cholera and other secretory diarrhea. The introduction of the antisecretory drug can minimize the hospital stay and reduce antibiotic use, which in turn can reduce the emergence of antibiotic resistance among pathogens
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
oral capsule
oral capsule
Icddr,b
Dhaka, Bangladesh
Change in stool output volume during treatment period.
Change in stool output volume (ml/hour) over a treatment period measured and plotted as total stool output during 12-hour stool collection at every 12 hours for 72 hours
Time frame: 3 days
Time until the stool volume output of 200 ml/hour
time (hours) from start of treatment until the stool output changes (reduces) to 200 ml/hour or less
Time frame: 3 days
Number of subjects with clinical recovery
Total number of subjects achieving clinical recovery during treatment period expressed as a fraction of the total subjects per treatment arm.
Time frame: 3 days
Number of unscheduled IV rehydration episodes per treatment
Average number of unscheduled IV rehydration episodes per participant per treatment arm.
Time frame: 3 days
Duration of IV rehydration
Average duration of IV rehydration per subject per treatment arm expressed in hours.
Time frame: 3 days
Adverse Events Occurrence
Average number of adverse events per subject per treatment arm
Time frame: 28 days
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