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| Name | Class |
|---|---|
| Société Francophone Nutrition Clinique et Métabolisme | OTHER |
| FIlière des Maladies rares Abdomino-THOraciques | UNKNOWN |
| Fresenius Kabi | INDUSTRY |
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The purpose of this study is to assess the drug absorption of oral antibiotics in patients with short bowel syndrome.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amoxicillin | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niasha MICHOT, MD | Contact | +33383155108 | n.michot@chru-nancy.fr | |
| Elise Pape | Contact | e.pape@chru-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Niasha MICHOT, MD | CHRU Nancy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Nancy | Recruiting | Vandœuvre-lès-Nancy | Lorraine | 54500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19446753 | Background | 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. | |
| 12671903 | Background | 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. |
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Depending on first results, this pilot study might be extended in a new multicenter study
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D064704 | Levofloxacin |
| D015242 | Ofloxacin |
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Levofloxacin | Drug | Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally |
|
| Ofloxacin | Drug | Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally |
|
| Sulfamethoxazole trimethoprim | Drug | Each patient will receive the proper antibiotic to treat the infection, first intravenously, then orally |
|
| 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 |
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 |
| 26944585 | Background | 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. |
| 17924895 | Background | 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. |
| 16970212 | Background | 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. |
| 20094812 | Result | 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. |
| 2292168 | Result | 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. |
| 1559306 | Result | Lamp KC, Bailey EM, Rybak MJ. Ofloxacin clinical pharmacokinetics. Clin Pharmacokinet. 1992 Jan;22(1):32-46. doi: 10.2165/00003088-199222010-00004. |
| 7924123 | Result | 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. |
| 15530127 | Result | 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. |
| 29127863 | Result | 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. |
| 24667978 | Result | 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. |
| 9724482 | Result | 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. |
| 7619677 | Result | 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. |
| 6699766 | Result | 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. |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |