A single blind, placebo controlled, single center, randomized controlled pilot study to assess if low dose ciprofloxacin can induce antimicrobial resistance in Escherichia coli (HealthyFood Trial)
- Conditions
- antimicrobial resistance in Escherichia coliTherapeutic area: Phenomena and Processes [G] - Microbiological Phenomena [G06]
- Registration Number
- CTIS2023-506205-18-00
- Lead Sponsor
- Institute Of Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Able and willing to provide written informed consent, At least 18 years old, Not taking any immunosuppressive agents and not clinically immunocompromised at the time of randomization, For females of childbearing potential only, willingness to practice continuous effective contraception during the study and a negative pregnancy test at the screening visit. Note: In accordance with ICH M3, the following will be classified as ‘effective contraception’: implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or vasectomized partner.
Use of any antibiotics in the previous 2 months of Visit 1, Known contra-indications or allergy to ciprofloxacin, Presence of any other condition, that will (likely) require the administration of another antibiotic at the time of randomization, as assessed by the treating physician, Pregnant or breastfeeding, Negative culture for E. coli at Visit 2
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