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

Central Hospital, Nancy, France

Status and phase: Enrolling; Phase 1

Conditions: Short Bowel Syndrome; Infection, Bacterial

Treatments: Drug: Levofloxacin; Drug: Ofloxacin; Drug: Sulfamethoxazole trimethoprim; Drug: Amoxicillin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05302531

2021-001468-13

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 4 patient groups

Amoxicillin

Experimental group

Description:

Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.

Treatment:

Drug: Amoxicillin

Ofloxacin

Experimental group

Description:

Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.

Treatment:

Drug: Ofloxacin

Levofloxacin

Experimental group

Description:

Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.

Treatment:

Drug: Levofloxacin

Sulfamethoxazole trimethoprim

Experimental group

Description:

Each patient will receive the IV antibiotic required to treat the infection, and after the proper duration of the IV antibiotic is over, the patient will receive a few days of the oral version of the same antibiotic.

Treatment:

Drug: Sulfamethoxazole trimethoprim