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Идёт набор NCT05302531

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

Фаза I С лечением Short Bowel Syndrome Infection, Bacterial

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Amoxicillin, Levofloxacin, Ofloxacin, Sulfamethoxazole trimethoprim.
Кому может быть актуально
Состояния в реестре: Short Bowel Syndrome, Infection, Bacterial. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

The purpose of this study is to assess the drug absorption of oral antibiotics in patients with short bowel syndrome.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • CHRU Nancy — Vandœuvre-lès-Nancy

Публикации

  • 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

Идентификаторы

NCT: NCT05302531 · 2021-001468-13

Первоисточники (государственные реестры)

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