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

Last updated: August 28, 2024
Sponsor: Central Hospital, Nancy, France
Overall Status: Active - Recruiting

Phase

1

Condition

Bacterial Infections

Bowel Dysfunction

Treatment

Sulfamethoxazole trimethoprim

Levofloxacin

Amoxicillin

Clinical Study ID

NCT05302531
2021-001468-13
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Short bowel syndrome

  • Treated for a documented infection with antibiogram by amoxicillin (+/- clavulanicacid)or ofloxacin or levofloxacin or sulfamethoxazole/trimethoprim

  • Hospitalized in the Nutritional Assistant Unit or the Infectiology Unit of theRegional 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 signedthe informed consent

Exclusion

Exclusion Criteria:

  • 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 publichealth

  • Person deprived of liberty or person undergoing psychiatric care pursuant toarticles L. 3212-1 et L. 3213-1

Study Design

Total Participants: 10
Treatment Group(s): 4
Primary Treatment: Sulfamethoxazole trimethoprim
Phase: 1
Study Start date:
December 09, 2022
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • CHRU Nancy

    Vandœuvre-lès-Nancy, Lorraine 54500
    France

    Active - Recruiting

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