Clinical trial NCT05337566: Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections
Official title: Infections After Hysterectomy - a Placebo-controlled Study Comparing the Prophylactic Use of Azithromycin and Cefuroxime With Single Cefuroxime
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infection Post Op
Hysterectomy
Antibiotics
Prophylactic
Keywords: postoperative, infection, hysterectomy, antibiotics
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Turku
name: Tampere University Hospital
name: Kuopio University Hospital
name: Oulu University Hospital
name: Jyväskylä Central Hospital
First posted: 2022-04-20
Enrollment: 2278
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of post-hysterectomy episodes with deep infections
timeFrame: Deep infections that occur between the first and 30th postoperative day after hysterectomy
Secondary outcomes:
measure: Number of other post-hysterectomy infections or fever episodes
timeFrame: Number of other infections or fever episodes that occur between the first and 30th postoperative day after hysterectomy.
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Jyväskylä
country: Finland
facility: Jyväskylä Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Central Hospital
city: Oulu
country: Finland
facility: Oulu University Central Hospital
city: Tampere
country: Finland
facility: Tampere University Central Hospital
city: Turku
country: Finland
facility: Turku University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Päivi Rahkola-Soisalo, Adj prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Tomi Mikkola, Prof, MD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Päivi Rahkola-Soisalo, Adj prof, MD
role: STUDY_DIRECTOR
References: