Status:
COMPLETED
Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera
Lead Sponsor:
Hunazine Biotech S.L.
Conditions:
Cholera
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06193408
Start Date
February 11 2024
End Date
September 8 2024
Last Update
September 23 2024
Active Locations (1)
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1
Icddr,b
Dhaka, Bangladesh