Assessing how well antibiotics are absorbed in patients with short bowel syndrome
Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome : a Monocentric Pilot Study
PHASE1 · Central Hospital, Nancy, France · NCT05302531
This study tests how well patients with short bowel syndrome can absorb oral antibiotics compared to intravenous ones to improve their treatment for infections.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France (other) |
| Locations | 1 site (Vandœuvre-lès-Nancy, Lorraine) |
| Trial ID | NCT05302531 on ClinicalTrials.gov |
What this trial studies
This study evaluates the absorption of oral antibiotics in patients diagnosed with short bowel syndrome who are being treated for infections. Initially, patients will receive intravenous antibiotics, and their pharmacokinetic profiles will be measured. Following this, the same antibiotics will be administered orally, and the absorption rates will be compared to determine the effectiveness of oral administration in this patient population. The study aims to improve treatment strategies for infections in patients with compromised intestinal absorption.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized patients with short bowel syndrome who require treatment for a documented infection.
Not a fit: Patients who are at risk of worsening their oral absorption abilities or those requiring dialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective oral antibiotic treatments for patients with short bowel syndrome.
How similar studies have performed: While there is limited data on this specific approach, similar studies have explored antibiotic absorption in various populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vandœuvre-lès-Nancy, Lorraine
- CHRU Nancy — Vandœuvre-lès-Nancy, Lorraine, France (RECRUITING)
Study contacts
- Principal investigator: Niasha MICHOT, MD — CHRU Nancy
- Study coordinator: Niasha MICHOT, MD
- Email: n.michot@chru-nancy.fr
- Phone: +33383155108
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Short Bowel Syndrome, Infection, Bacterial