Short Bowel Syndrome, Infection, Bacterial
Conditions
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.
Interventions
DRUGAmoxicillin
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
DRUGLevofloxacin
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
DRUGOfloxacin
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
Sponsors
Société Francophone Nutrition Clinique et Métabolisme
FIlière des Maladies rares Abdomino-THOraciques
Fresenius Kabi
Central Hospital, Nancy, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome | Time -0.5 hours | F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Peak plasma concentration (Cmax) after oral intake |
| Assess link between length of remaining bowel and antibiotic absorption | At inclusion | Length of remaining bowel (cm) |
Countries
France
Contacts
Primary ContactNiasha MICHOT, MD
Backup ContactElise Pape
Outcome results
None listed