Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera
Status:
Recruiting
Trial end date:
2024-06-15
Target enrollment:
Participant gender:
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