Granules in the improvement of oral heparin bioavailability.
J Scala-Bertola, M Rabiskova, T Lecompte...
https://pubmed.ncbi.nlm.nih.gov/19446753Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID05302531
Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome: a Monocentric Pilot Study
Led by Central Hospital, Nancy, France · Updated on 2024-08-29
10
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
C
Central Hospital, Nancy, France
Lead Sponsor
S
Société Francophone Nutrition Clinique et Métabolisme
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well oral antibiotics are absorbed in patients with short bowel syndrome. This condition can affect how medications are processed in the body. The study aims to compare the absorption of antibiotics given intravenously and then orally to better understand the oral bioavailability in these patients. Each participant will first receive an intravenous antibiotic to treat their infection. After completing this intravenous treatment, they will be given the same antibiotic orally for a few days. The antibiotics studied include amoxicillin, ofloxacin, levofloxacin, and sulfamethoxazole/trimethoprim. This pilot study is being conducted at a single center. During the study, researchers will measure the levels of the antibiotic in the blood at multiple time points before and after oral administration to assess absorption. They will also collect information about the length of the remaining bowel and its relationship with antibiotic absorption. Participants will be monitored closely throughout the treatment periods, and the study will continue until February 2025.
CONDITIONS
Brief Title
Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with short bowel syndrome
- Treated for a documented infection with amoxicillin (+/- clavulanic acid), ofloxacin, 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
- Received a physical examination before entering the study
- Provided informed consent after full information about the study
You will not qualify if you...
- At risk of worsening oral absorption during the study
- Requires dialysis treatment
- Woman of childbearing age without effective birth control
- Allergy to any of the tested drugs
- Subject to specific legal restrictions under French public health code
- Deprived of liberty or undergoing psychiatric care under certain legal articles
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of intravenous antibiotic treatment plus a few days of oral antibiotic
Participants receive intravenous antibiotic treatment for their infection followed by a few days of the same antibiotic administered orally. Pharmacokinetic profiles are determined during both intravenous and oral administration to assess antibiotic absorption.
Multiple visits timed around antibiotic administration and pharmacokinetic sampling
Trial Site Locations
Total: 1 location
1
CHRU Nancy
Vandœuvre-lès-Nancy, Lorraine, France, 54500
Actively Recruiting
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Research Team
N
Niasha MICHOT, MD
E
Elise Pape
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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https://pubmed.ncbi.nlm.nih.gov/20094812Clinical pharmacokinetics of ciprofloxacin.
K Vance-Bryan, D R Guay, J C Rotschafer
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K C Lamp, E M Bailey, M J Rybak
https://pubmed.ncbi.nlm.nih.gov/1559306Differential absorption of amoxicillin from the human small and large intestine.
W H Barr, E M Zola, E L Candler...
https://pubmed.ncbi.nlm.nih.gov/7924123Enteral drug absorption in patients with short small bowel : a review.
René Severijnen, Nazila Bayat, Hans Bakker...
https://pubmed.ncbi.nlm.nih.gov/15530127