Clinical trial NCT06193408: Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera
Official title: Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera: a Phase II, Randomized, Placebo-controlled, Double-blinded Efficacy and Safety Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholera
Lead sponsor: Hunazine Biotech S.L.
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Signed informed consent.
* Adults, both genders aged 18-65 years.
* Acute watery diarrhea (defined as passage of three or more liquid stools within the 24 hours before admission) with severe dehydration on arrival.
* Detection of V. cholerae by rapid diagnostic assay (e.g. dark field microscopy).

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products.
* Subjects with passage of bloody stools or muco-purulent stools.
* Subjects with chronic diarrhea (\>4 weeks of Diarrhea).
* Clinically significant concomitant systemic disease (i.e. cardiovascular diseases including heart failure, acute kidney injury, sepsis or life-threatening malignant cancer).
* Mental incapacity, unwillingness, or language barriers, precluding adequate understanding or cooperation.
* History of receiving antimicrobial or antidiarrheal drugs within 6 hours prior to admission.
* Positive urine pregnancy test for all female patients
* Failure to obtain informed consent.
* Failure to definitively diagnose cholera via culture or RT-PCR

Primary outcomes:
measure: Change in stool output volume during treatment period.
timeFrame: 3 days
Secondary outcomes:
measure: Time until the stool volume output of 200 ml/hour
timeFrame: 3 days
measure: Number of subjects with clinical recovery
timeFrame: 3 days
measure: Number of unscheduled IV rehydration episodes per treatment
timeFrame: 3 days
measure: Duration of IV rehydration
timeFrame: 3 days
measure: Adverse Events Occurrence
timeFrame: 28 days
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Icddr,b
Study officials:
References: