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

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

Detailed Description
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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.

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

Conditions
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Short Bowel Syndrome, Infection, Bacterial

Intervention / Treatment
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* Drug: Amoxicillin
* Drug: Levofloxacin
* Drug: Ofloxacin
* Drug: Sulfamethoxazole trimethoprim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amoxicillin<br>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. | Drug: Amoxicillin<br>* Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally<br>|
| Experimental: Ofloxacin<br>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. | Drug: Ofloxacin<br>* Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally<br>|
| Experimental: Levofloxacin<br>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. | Drug: Levofloxacin<br>* Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally<br>|
| Experimental: Sulfamethoxazole trimethoprim<br>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. | Drug: Sulfamethoxazole trimethoprim<br>* Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome | F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO) | Time -0.5 hours | 
| Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome | F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO) | Time +0.5 hours | 
| Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome | F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO) | Time +1 hour | 
| Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome | F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO) | Time +1.5 hour | 
| Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome | F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO) | Time +2 hours | 
| Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome | F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO) | Time +4 hours | 
| Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome | F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO) | Time +6 hours | 
| Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome | F (%)=(ASC PO)/(ASC IV) x (Dose IV)/(Dose PO) | Time +8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe antibiotic absorption after oral administration in these patients | Peak plasma concentration (Cmax) after oral intake | 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 | 
| Describe antibiotic absorption after oral administration in these patients | Peak plasma concentration time after oral intake (Tmax) | 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 | 
| Describe antibiotic absorption after oral administration in these patients | Area under the plasma concentration versus time curve (AUC) | 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 | 
| Assess link between length of remaining bowel and antibiotic absorption | Length of remaining bowel (cm) | At inclusion |