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Recruiting NCT05302531

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

Phase I Interventional Short Bowel Syndrome Infection, Bacterial

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Amoxicillin, Levofloxacin, Ofloxacin, Sulfamethoxazole trimethoprim.
Who it may be relevant to
Registry conditions: Short Bowel Syndrome, Infection, Bacterial. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Amoxicillin
    Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
  • Drug Levofloxacin
    Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
  • Drug Ofloxacin
    Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
  • Drug Sulfamethoxazole trimethoprim
    Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally

Primary outcome measures

  • Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome [Time frame: Time -0.5 hours]
  • Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome [Time frame: Time +0.5 hours]
  • Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome [Time frame: Time +1 hour]
  • Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome [Time frame: Time +1.5 hour]
  • Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome [Time frame: Time +2 hours]
  • Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome [Time frame: Time +4 hours]
  • Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome [Time frame: Time +6 hours]
  • Assess the bioavailability of the oral antibiotic in patient with short bowel syndrome [Time frame: Time +8 hours]
Secondary outcome measures (4)
  • Describe antibiotic absorption after oral administration in these patients [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: At inclusion]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CHRU Nancy — Vandœuvre-lès-Nancy

Publications

  • Scala-Bertola J, Rabiskova M, Lecompte T, Bonneaux F, Maincent P. Granules in the improvement of oral heparin bioavailability. Int J Pharm. 2009 Jun 5;374(1-2):12-6. doi: 10.1016/j.ijpharm.2009.02.020. Epub 2009 Mar 9. PMID 19446753
  • American Gastroenterological Association. American Gastroenterological Association medical position statement: short bowel syndrome and intestinal transplantation. Gastroenterology. 2003 Apr;124(4):1105-10. doi: 10.1053/gast.2003.50139. No abstract available. PMID 12671903
  • Pironi L, Arends J, Bozzetti F, Cuerda C, Gillanders L, Jeppesen PB, Joly F, Kelly D, Lal S, Staun M, Szczepanek K, Van Gossum A, Wanten G, Schneider SM; Home Artificial Nutrition & Chronic Intestinal Failure Special Interest Group of ESPEN. ESPEN guidelines on chronic intestinal failure in adults. Clin Nutr. 2016 Apr;35(2):247-307. doi: 10.1016/j.clnu.2016.01.020. Epub 2016 Feb 8. PMID 26944585
  • Gupta A, Mehta Y, Juneja R, Trehan N. The effect of cannula material on the incidence of peripheral venous thrombophlebitis. Anaesthesia. 2007 Nov;62(11):1139-42. doi: 10.1111/j.1365-2044.2007.05180.x. PMID 17924895
  • Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc. 2006 Sep;81(9):1159-71. doi: 10.4065/81.9.1159. PMID 16970212
  • Ward N. The impact of intestinal failure on oral drug absorption: a review. J Gastrointest Surg. 2010 Jun;14(6):1045-51. doi: 10.1007/s11605-009-1151-9. Epub 2010 Jan 22. PMID 20094812
  • Vance-Bryan K, Guay DR, Rotschafer JC. Clinical pharmacokinetics of ciprofloxacin. Clin Pharmacokinet. 1990 Dec;19(6):434-61. doi: 10.2165/00003088-199019060-00003. PMID 2292168
  • Lamp KC, Bailey EM, Rybak MJ. Ofloxacin clinical pharmacokinetics. Clin Pharmacokinet. 1992 Jan;22(1):32-46. doi: 10.2165/00003088-199222010-00004. PMID 1559306

Identifiers

NCT: NCT05302531 · 2021-001468-13

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗