Phase 2
N=150
Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera
Cholera
Bottom Line
View on ClinicalTrials.gov: NCT06193408 ↗Enrolled (actual)
150
Serious AEs
0.7%
Results posted
Mar 2026
Primary outcome: Primary: Stool Output Volume During Treatment Period. — 9.82; 9.31; 5.69; 7.29 ml/kg·h-1 — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VR-AD-1005 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hunazine Biotech S.L.
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stool Output Volume During Treatment Period. |
9.82; 9.31; 5.69; 7.29; 5.32; 7.93 | 0.003 sig |
| SECONDARY Duration of Stool Output in Excess of 200 ml/Hour |
10; 15 | 0.05 |
| SECONDARY Number of Unscheduled IV Rehydration Episodes Per Treatment |
0.93; 1.11 | — |
| SECONDARY Volume of IV Rehydration, ml/kg |
30.8; 51; 40.5; 57; 41.1; 57 | — |
| SECONDARY Time Until Last Liquid Stool |
27; 28 | 0.045 sig |
| SECONDARY Duration of Stool Output in Excess of 400 mL/Hour |
5; 8 | 0.006 sig |
| SECONDARY Participants With at Least One Adverse Event |
1; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT06193408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.