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

Cholera Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06193408
• Other study ID #: PR-23089
• Status: Recruiting
• Phase: Phase 2
• Start date: February 11, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: February 2024
• Source: Hunazine Biotech S.L.
• Contact: Dmitry V Kravtsov, MD
• Phone: +1 203 836 8424 x 114
• Email: dmitry.kravtsov[@]hunazinebiotech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholera
• Diarrhea

Intervention

Drug:
• VR-AD-1005
oral capsule
• Placebo
oral capsule

Locations

Country	Name	City	State
Bangladesh	Icddr,b	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Hunazine Biotech S.L.

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in stool output volume during treatment period.	Change in stool output volume (ml/hour) over a treatment period measured and plotted as total stool output during 12-hour stool collection at every 12 hours for 72 hours	3 days
Secondary	Time until the stool volume output of 200 ml/hour	time (hours) from start of treatment until the stool output changes (reduces) to 200 ml/hour or less	3 days
Secondary	Number of subjects with clinical recovery	Total number of subjects achieving clinical recovery during treatment period expressed as a fraction of the total subjects per treatment arm.	3 days
Secondary	Number of unscheduled IV rehydration episodes per treatment	Average number of unscheduled IV rehydration episodes per participant per treatment arm.	3 days
Secondary	Duration of IV rehydration	Average duration of IV rehydration per subject per treatment arm expressed in hours.	3 days
Secondary	Adverse Events Occurrence	Average number of adverse events per subject per treatment arm	28 days