Effects of IV Omadacycline on Gut Microbiome

IRB00081259

Given the clinical need to improve upon current antibiotic regimens for the treatment of C. difficile infection with a particular focus on the impact of therapies on gut microbiome, this study proposes to characterize the impact of Intravenous (IV) omadacycline on gut microbiome of healthy volunteers.

2023-03-20

2024-10-01

2024-10-01

Recruiting

Early phase I

8

Inclusion Criteria: * 18-40 years of age * Willing and able to comply with all study procedures * Considered healthy without history of cardiovascular, gastrointestinal, hepatic, or renal disease * males or females - females of child bearing potential must agree to use a highly effective contraception during the study and for at least 7 days after the last dose of omadacycline Exclusion Criteria: * Consumed probiotics within 30 days before enrollment * Consumed antibiotics within 90 days prior to enrollment * Known hypersensitivity to omadacycline or tetracycline-class antibiotics * pregnant or breastfeeding * in the opinion of the investigator is experiencing signs or symptoms of acute illness that increase the risk of adverse effects from participating in the study * previously participated in the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ESTIMATED'}}

2024-04-25