NCT05302531

Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome

Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome : a Monocentric Pilot Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the drug absorption of oral antibiotics in patients with short bowel syndrome.

Detailed description

When required, due to an infection, patients with short bowel syndrome will be treated with an intravenous antibiotic. The pharmacokinetic profile of that intravenous antibiotic will be determined. Once the full treatment with the intravenous antibiotic is over, the patient will be orally administered the same antibiotic, with determination of the oral pharmacokinetic profile, and both profiles will be compared, assessing the bioavailability of the oral antibiotic.

Conditions

• Short Bowel Syndrome
• Infection, Bacterial

Interventions

Type	Name	Description
DRUG	Amoxicillin	Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
DRUG	Levofloxacin	Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
DRUG	Ofloxacin	Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
DRUG	Sulfamethoxazole trimethoprim	Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally

Timeline

• Start date: 2022-12-09
• Primary completion: 2024-12-01
• Completion: 2025-02-01
• First posted: 2022-03-31
• Last updated: 2024-08-29

Locations

1 site across 1 country: France