Status:
RECRUITING
Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome
Lead Sponsor:
Central Hospital, Nancy, France
Collaborating Sponsors:
Société Francophone Nutrition Clinique et Métabolisme
FIlière des Maladies rares Abdomino-THOraciques
Conditions:
Short Bowel Syndrome
Infection, Bacterial
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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. On...
Eligibility Criteria
Inclusion
- Short bowel syndrome
- Treated for a documented infection with antibiogram by amoxicillin (+/- clavulanic acid)or ofloxacin or levofloxacin or sulfamethoxazole/trimethoprim
- Hospitalized in the Nutritional Assistant Unit or the Infectiology Unit of the Regional University Hospital of Nancy
- Affiliated to a social security system
- Having received an physical examination before entering study
- Having received full information regarding the study organization and having signed the informed consent
Exclusion
- Patient at risk of worsening their oral absorption abilities during study
- Patient requiring dialysis
- Women of childbearing age without efficient birth control
- Allergy to any of the drugs tested
- Person concerned by Articles L. 1121-5, L. 1121-7 et L1121-8 of the Code of public health
- Person deprived of liberty or person undergoing psychiatric care pursuant to articles L. 3212-1 et L. 3213-1
Key Trial Info
Start Date :
December 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05302531
Start Date
December 9 2022
End Date
February 1 2025
Last Update
August 29 2024
Active Locations (1)
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1
CHRU Nancy
Vandœuvre-lès-Nancy, Lorraine, France, 54500