Clinical trial

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

ID

Name

2021-001468-13

Description

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

Trial arms

Trial start

2022-12-09

Estimated PCD

2024-12-01

Trial end

2025-02-01

Status

Recruiting

Phase

Early phase I

Treatment

Amoxicillin

Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally

Arms:

Amoxicillin

Levofloxacin

Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally

Arms:

Levofloxacin

Ofloxacin

Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally

Arms:

Ofloxacin

Sulfamethoxazole trimethoprim

Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally

Arms:

Sulfamethoxazole trimethoprim

Size

10

Primary endpoint

Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

Time -0.5 hours

Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

Time +0.5 hours

Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

Time +1 hour

Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

Time +1.5 hour

Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

Time +2 hours

Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

Time +4 hours

Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

Time +6 hours

Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome

Time +8 hours

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}

Updated at

2023-02-14

1 organization

4 products

3 indications

Organization

Central Hospital

Product

Indication

Short Bowel Syndrome

Indication

Indication

Product

Product

Product

Sulfamethoxazole Trimethoprim