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

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

Recruiting
18 years and older
All
Phase 1

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Overview

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

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.

Eligibility

Inclusion Criteria:

  • 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 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 public health
  • Person deprived of liberty or person undergoing psychiatric care pursuant to articles L. 3212-1 et L. 3213-1

Study details
    Short Bowel Syndrome
    Infection
    Bacterial

NCT05302531

Central Hospital, Nancy, France

26 January 2024

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