Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome
- Conditions
- Short Bowel SyndromeInfection, Bacterial
- Interventions
- Registration Number
- NCT05302531
- Lead Sponsor
- Central Hospital, Nancy, France
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Levofloxacin Levofloxacin 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. Sulfamethoxazole trimethoprim Sulfamethoxazole trimethoprim 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. Ofloxacin Ofloxacin 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. Amoxicillin Amoxicillin 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.
- Primary Outcome Measures
Name Time Method Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome Time +8 hours F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO)
- Secondary Outcome Measures
Name Time Method Describe antibiotic absorption after oral administration in these patients 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 Area under the plasma concentration versus time curve (AUC)
Assess link between length of remaining bowel and antibiotic absorption At inclusion Length of remaining bowel (cm)
Trial Locations
- Locations (1)
CHRU Nancy
🇫🇷Vandœuvre-lès-Nancy, Lorraine, France