CholeraPhase 2NCT06193408
Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera
A Phase 2 study testing VR-AD-1005 in people with Cholera, run by Hunazine Biotech S.L. at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholera
- What is being tested?
- VR-AD-1005
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteBangladesh
- Study dates
- 11 Feb 2024to 8 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- Positive urine pregnancy test for all female patients
- Failure to obtain informed consent.
- Failure to definitively diagnose cholera via culture or RT-PCR
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Cholera
- Being tested
- VR-AD-1005, Placebo
- Medical subject headings
- Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-AD-1005Drug
oral capsule
PlaceboDrug
oral capsule
| Study group | Role | What they receive |
|---|---|---|
| VR-AD-1005 | Experimental | Not described Receives: Drug: VR-AD-1005 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool Output Volume During Treatment Period.
Means of stool output data expressed as ml/kg·h-1 for Treatment and Comparator groups.
Measured: Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours, e.g. hour 1, hour 6, hour 8, hour 10, hour 11, hour 22, hour 23, hour 26, etc.).
Secondary outcomes (6)
Duration of Stool Output in Excess of 200 ml/Hour
For analysis, individual stool charts were used to calculate stool output per patient per hour and express it as stool volume in ml/hour. Duration of time during treatment when stool output was in excess of 200ml/hour was calculated for each participant and compared for control and study intervention groups.
Measured: Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).
Number of Unscheduled IV Rehydration Episodes Per Treatment
Average number of unscheduled IV rehydration episodes per participant per study arm.
Measured: Unscheduled IV rehydration episodes were measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).
Volume of IV Rehydration, ml/kg
Average volume of IV rehydration per subject per treatment arm was calculated as aggregate per time period. Data were analyzed for three time periods, namely 0-12 hours; 0-24 hours; and the entire duration of treatment. For each period, mean volume of the infusion was calculated and expressed in ml/kg body weight.
Measured: Volume of administered IV rehydration solution was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).
Time Until Last Liquid Stool
Diarrhea duration is measured from the first dose of study drug to resolution. Time (hours) from start of treatment until the last liquid stool was determined for each participant. Data were extracted from individual stool charts, and time-to-criterion was analyzed using log-rank statistics between the Treatment and the Comparator groups.
Measured: Liquid and solid stool output was measured by trained trial personnel and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).
Duration of Stool Output in Excess of 400 mL/Hour
For analysis, individual stool charts were used to calculate stool output per patient per hour and express it as stool volume in ml/hour. Duration of time during treatment when stool output was in excess of 400ml/hour was calculated for each participant and compared for control and study intervention groups.
Measured: Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).
Participants With at Least One Adverse Event
Proportion of participants experiencing at least one adverse event (including serious adverse events) following administration of study treatment during the safety evaluation period.
Measured: From enrollment until the end of follow-up, up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start11 Feb 2024
- Primary completion11 Aug 2024
- Study completion8 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CholeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunazine Biotech S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193408
- Sponsor's protocol ID
- PR-23089
- Status last verified
- May 2026
- First submitted
- 12 Dec 2023
- Last updated
- 2 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06193408
- Acronym / sponsor ID
- PR-23089
- Conditions
- Cholera
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hunazine Biotech S.L.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2024 (actual)
- Primary completion
- 11 Aug 2024 (actual)
- Study completion
- 8 Sep 2024 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Posted 12 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-AD-1005 | Experimental | Drug: VR-AD-1005 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-AD-1005oral capsule | Drug | VR-AD-1005 |
| Placebooral capsule | Drug | Placebo |
Primary outcome
Stool Output Volume During Treatment Period.
Time frame: Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours, e.g. hour 1, hour 6, hour 8, hour 10, hour 11, hour 22, hour 23, hour 26, etc.).
Means of stool output data expressed as ml/kg·h-1 for Treatment and Comparator groups.
6 secondary outcomes
Duration of Stool Output in Excess of 200 ml/Hour
Time frame: Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).
Number of Unscheduled IV Rehydration Episodes Per Treatment
Time frame: Unscheduled IV rehydration episodes were measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).
Volume of IV Rehydration, ml/kg
Time frame: Volume of administered IV rehydration solution was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).
Time Until Last Liquid Stool
Time frame: Liquid and solid stool output was measured by trained trial personnel and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).
Duration of Stool Output in Excess of 400 mL/Hour
Time frame: Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).
Participants With at Least One Adverse Event
Time frame: From enrollment until the end of follow-up, up to 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VR-AD-1005 in people with Cholera, run by Hunazine Biotech S.L. at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool Output Volume During Treatment Period. (time frame: Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours, e.g. hour 1, hour 6, hour 8, hour 10, hour 11, hour 22, hour 23, hour 26, etc.).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.