Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

Официальное название

Infections After Hysterectomy - a Placebo-controlled Study Comparing the Prophylactic Use of Azithromycin and Cefuroxime With Single Cefuroxime

Обзор

During hysterectomy bacteria may enter into the peritoneal cavity through vaginal opening and contaminate the healing tissues. The risk for deep infection after hysterectomy is about 5%. By reducing post-hysterectomy infections, it is possible to reduce individual burden of disease in addition to the direct and indirect financial costs. This study primary aim is to assess if prophylactic preoperative use of azithromycin in addition to generally used cefuroxime decreases post-hysterectomy infections as compared to cefuroxime only prophylaxis during 30 days after hysterectomy. Secondary aim is to assess if there is change in post-hysterectomy superficial infections, urinary tract infections, or post-operative fever between the cohorts and to report possible side-effects of the used antibiotics. In addition, the study finds out a possible role of bacterial vaginosis and microbiome n post-hysterectomy infections.

Вмешательства

• Препарат Azithromycin Pill + Cefuroxime
  Azithromycin 500 mg (2 tablets) per orally when arriving to the hospital before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision
• Препарат Placebo + Cefuroxime
  Placebo (2 tablets) per orally in the evening when arriving to the hospital before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision

Первичные конечные точки

• Number of post-hysterectomy episodes with deep infections [Срок оценки: Deep infections that occur between the first and 30th postoperative day after hysterectomy]

Вторичные конечные точки (1)

• Number of other post-hysterectomy infections or fever episodes [Срок оценки: Number of other infections or fever episodes that occur between the first and 30th postoperative day after hysterectomy.]

Критерии участия

Критерии включения

• Women undergoing hysterectomy for benign indication in University Hospitals (Helsinki University Hospital, Turku University Hospital, Tampere University Hospital, Oulu University Hospital and Kuopio University Hospital) who have not any contraindications for azithromycin or cefuroxime.

Критерии исключения

• Inability to understand the study protocol.
• Allergy for either cefuroxime or azithromycin.
• Congenital or acquired prolonged Q-T-corrected interval. All the participants will be asked about arrhythmias and whether they have congenital arrhythmias in the family,
• Electrocardiogram will be checked for all the participants.
• Use of medicines that may prolong Q-T-corrected interval (class Ia arrhythmia medications, quinidine, procainamide, and class III arrhythmia medications dofetilide, amiodarone and sotalol).
• Use of selective serotonin reuptake inhibitor medication and prolonged Q-T-corrected interval.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Финляндия · 6 центров

• Helsinki University Central Hospital — Helsinki
• Jyväskylä Central Hospital — Jyväskylä
• Kuopio University Central Hospital — Kuopio
• Oulu University Central Hospital — Oulu
• Tampere University Central Hospital — Tampere
• Turku University Central Hospital — Turku

Идентификаторы

NCT: NCT05337566 · HUS/117/2022 · 2021-003467-10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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