CompletedPhase 2

Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD

United States34 participantsStarted 2019-02-07

Plain-language summary

The objective of this Phase IIa study is to assess the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 in patients with Clostridium difficile-associated diarrhea (CDAD).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 18 years or older of any gender.
✓. Inpatients and/or outpatients who are able to attend all scheduled visits.
✓. Patients with the first episode or the first recurrence of mild or moderate CDAD.
✓. Confirmed diagnosis of mild or moderate CDAD as defined by the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America guidelines.

Exclusion criteria

✕. Patients with severe complicated CDAD (including hypotension or shock, ileus, megacolon, pseudomembranous colitis).
✕. A white blood cell count higher than 15,000 cells/mL.
✕. A serum creatinine level greater than or equal to 1.5 times ULN.
✕. Elevated liver enzymes alanine aminotransferase and aspartate aminotransferase greater than ULN.
✕. Inflammatory bowel disease (ulcerative colitis or Crohn's disease), microscopic colitis, or irritable bowel syndrome with chronic diarrhea.
✕. Any other non-C difficile diarrhea.
✕. Received treatment with a fecal transplant within 7 days and/or is anticipated to receive a fecal transplant during the study.
✕. Major gastrointestinal surgery (ie, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy).

What they're measuring

Number of participants with treatment-related adverse events assessed by the Investigator, as per CTCAE v.5.0.

Timeframe: 40 days

Initial cure rate at 12 days post initiation of therapy.

Timeframe: 12 days

Trial details

NCT IDNCT03824795

SponsorMGB Biopharma Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-03

View on ClinicalTrials.gov More Clostridium Difficile Infection trials