Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome
NCT ID: NCT05302531
Last Updated: 2024-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2022-12-09
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Amoxicillin
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.
Amoxicillin
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
Ofloxacin
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.
Ofloxacin
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
Levofloxacin
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.
Levofloxacin
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
Sulfamethoxazole trimethoprim
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.
Sulfamethoxazole trimethoprim
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
Interventions
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Amoxicillin
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
Levofloxacin
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
Ofloxacin
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
Sulfamethoxazole trimethoprim
Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Société Francophone Nutrition Clinique et Métabolisme
OTHER
FIlière des Maladies rares Abdomino-THOraciques
UNKNOWN
Fresenius Kabi
INDUSTRY
Central Hospital, Nancy, France
OTHER
Responsible Party
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MICHOT Niasha
Principal Investigator
Principal Investigators
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Niasha MICHOT, MD
Role: PRINCIPAL_INVESTIGATOR
CHRU Nancy
Locations
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CHRU Nancy
Vandœuvre-lès-Nancy, Lorraine, France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Lamp KC, Bailey EM, Rybak MJ. Ofloxacin clinical pharmacokinetics. Clin Pharmacokinet. 1992 Jan;22(1):32-46. doi: 10.2165/00003088-199222010-00004.
Barr WH, Zola EM, Candler EL, Hwang SM, Tendolkar AV, Shamburek R, Parker B, Hilty MD. Differential absorption of amoxicillin from the human small and large intestine. Clin Pharmacol Ther. 1994 Sep;56(3):279-85. doi: 10.1038/clpt.1994.138.
Severijnen R, Bayat N, Bakker H, Tolboom J, Bongaerts G. Enteral drug absorption in patients with short small bowel : a review. Clin Pharmacokinet. 2004;43(14):951-62. doi: 10.2165/00003088-200443140-00001.
Cheung YW, Barco S, Mathot RAA, van den Dool EJ, Stroobants AK, Serlie MJ, Middeldorp S, Coppens M. Pharmacokinetics of dabigatran etexilate and rivaroxaban in patients with short bowel syndrome requiring parenteral nutrition: The PDER PAN study. Thromb Res. 2017 Dec;160:76-82. doi: 10.1016/j.thromres.2017.10.025. Epub 2017 Nov 4.
Faye E, Drouet L, De Raucourt E, Green A, Bal-Dit-Sollier C, Boudaoud L, Corcos O, Bergmann JF, Joly F, Lloret-Linares C. Absorption and efficacy of acetylsalicylic acid in patients with short bowel syndrome. Ann Pharmacother. 2014 Jun;48(6):705-10. doi: 10.1177/1060028014526700. Epub 2014 Mar 25.
Thielke J, Martin J, Weber FL, Schroeder TJ, Goretsky S, Hanto DW. Pharmacokinetics of tacrolimus and cyclosporine in short-bowel syndrome. Liver Transpl Surg. 1998 Sep;4(5):432-4. doi: 10.1002/lt.500040502. No abstract available.
Ueno T, Tanaka A, Hamanaka Y, Suzuki T. Serum drug concentrations after oral administration of paracetamol to patients with surgical resection of the gastrointestinal tract. Br J Clin Pharmacol. 1995 Mar;39(3):330-2. doi: 10.1111/j.1365-2125.1995.tb04457.x.
Menardi G, Guggenbichler JP. Bioavailability of oral antibiotics in children with short-bowel syndrome. J Pediatr Surg. 1984 Feb;19(1):84-6. doi: 10.1016/s0022-3468(84)80023-8.
Other Identifiers
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2021-001468-13
Identifier Type: -
Identifier Source: org_study_id
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