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Completed

NCT Number: NCT06193408

Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera

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

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Key information

Conditions

Cholera Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Vibrio Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Icddr,b

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR-AD-1005

Drug

oral capsule

Placebo

Drug

oral capsule

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

    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.

  2. 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).

    Average number of unscheduled IV rehydration episodes per participant per study arm.

  3. 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).

    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.

  4. 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).

    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.

  5. 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).

    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.

  6. Participants With at Least One Adverse Event

    Time frame: From enrollment until the end of follow-up, up to 28 days

    Proportion of participants experiencing at least one adverse event (including serious adverse events) following administration of study treatment during the safety evaluation period.

Sponsors and collaborators

Lead sponsor

Hunazine Biotech S.L.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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