Clinical trial NCT05302531: Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome
Official title: Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome : a Monocentric Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Short Bowel Syndrome
Infection, Bacterial
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Société Francophone Nutrition Clinique et Métabolisme
name: FIlière des Maladies rares Abdomino-THOraciques
name: Fresenius Kabi
First posted: 2022-03-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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 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

Primary outcomes:
measure: Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
timeFrame: Time -0.5 hours
measure: Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
timeFrame: Time +0.5 hours
measure: Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
timeFrame: Time +1 hour
measure: Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
timeFrame: Time +1.5 hour
measure: Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
timeFrame: Time +2 hours
measure: Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
timeFrame: Time +4 hours
measure: Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
timeFrame: Time +6 hours
measure: Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome
timeFrame: Time +8 hours
Secondary outcomes:
measure: Describe antibiotic absorption after oral administration in these patients
timeFrame: Time -0.5hour ; Time +0.5hour ; Time +1 hour ; Time+1.5 hour ; Time +2 hours ; Time+4 hours ; Time +6 hours ; Time + 8 hours
measure: Describe antibiotic absorption after oral administration in these patients
timeFrame: Time -0.5hour ; Time +0.5hour ; Time +1 hour ; Time+1.5 hour ; Time +2 hours ; Time+4 hours ; Time +6 hours ; Time + 8 hours
measure: Describe antibiotic absorption after oral administration in these patients
timeFrame: Time -0.5hour ; Time +0.5hour ; Time +1 hour ; Time+1.5 hour ; Time +2 hours ; Time+4 hours ; Time +6 hours ; Time + 8 hours
measure: Assess link between length of remaining bowel and antibiotic absorption
timeFrame: At inclusion
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
state: Lorraine
Study officials:
affiliation: CHRU Nancy
name: Niasha MICHOT, MD
role: PRINCIPAL_INVESTIGATOR
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