Safety, tolerability, and efficacy trial of multiple daily administration of LFF571 for 10 days in patients with moderate Clostridium difficile infections

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 132

Inclusion Criteria

- Males and females between 18 and 90 years of age
- Females and males of childbearing potential must agree to use highly effective methods of contraception for the entire study duration, and must not attempt to become pregnant (including in vitro fertilization, sperm donation) for at least 30 days following the last study drug administration
- Diagnosed with primary episode or first relapse of mild and moderate C. difficile infection.
- Received =24 hours of approved therapy effective for C. difficile infection in the 3 days preceding enrollment.
- Not expected to require >72 hours of concomitant systemic or orally administered antibiotics for the treatment of other infections during the treatment period.
- Ability to take oral medications
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 92
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment.
- History of hypersensitivity or intolerance to the study drug or to drugs of similar chemical classes.
- Other suspected cause of diarrhea.
- Severe C. difficile infection.
- More than one prior episode of C. difficile infection within the prior 3 months.
- Severe underlying disease such that the patient is not expected to survive at least 3 months.
- Abdominal surgery within 30 days prior to enrollment (major or minor abdominal surgery within 14 to 30 days prior to enrollment is allowed if the investigator determines that it does not impact gastrointestinal transit time or absorption) as well as colostomy, ileostomy, or other similar surgical procedures. Any of the following if the investigator determines it could impact gastrointestinal transit time or absorption:
• Abdominal surgery more than 30 days prior to enrollment.
• Chronic intestinal diseases or disorders such as Crohn’s disease, ulcerative colitis, or irritable bowel syndrome.
- Known to have HIV infection with CD4 count <200 cells/µL (testing not required) or other clinically significant immunosuppressive disease.
- Chemotherapy or other therapy within the 30 days prior to enrollment or during the study period that is expected to result in neutropenia requiring antimicrobial therapy during the treatment period.
- Neutropenia (absolute neutrophil count <1000 cells/µL).
- Renal insufficiency with a calculated creatinine clearance <30 mL/min or the need for hemodialysis or peritoneal dialysis.
- Evidence of liver disease defined as aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or total bilirubin levels more than five times the upper limit of normal.
- History of chronic liver disease such as cirrhosis with a Child-Pugh score of B or C.
- Thrombocytopenia (<50,000 platelets/µL).
- Anemia (hemoglobin value <8.0 gm/dL).
- Currently taking or planning to take Saccharomyces boulardii during the study.
- Expected use of anti-peristaltic drugs, cholestyramine, or colestipol from Day 1 through the end-of-therapy visit on Day 12 or 13.
- Pregnant or nursing (lactating) women.
- Prior enrollment in this study, CLFF571X2201.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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