Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

Helsinki University Central Hospital (HUCH)

Status: Enrolling

Conditions: Prophylactic; Antibiotics; Hysterectomy; Infection Post Op

Treatments: Drug: Placebo + Cefuroxime; Drug: Azithromycin Pill + Cefuroxime

Study type: Interventional

Funder types: Other

Identifiers

NCT05337566

HUS/117/2022

2021-003467-10 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 2,278 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,278 participants in 2 patient groups

Azithromycin + Cefuroxime

Experimental group

Description:

Changed with renewed study permissions: These patients will receive Azithromycin 500 mg (2 tablets) per orally on the operation day when they arrive to the hospital and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose bosy mass index is 30 or more) in the operating theatre before the incision. The previous description: These patients will receive Azithromycin 500 mg (2 tablets) per orally in the evening before the operation and 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.

Treatment:

Drug: Azithromycin Pill + Cefuroxime

Placebo + Cefuroxime

Active Comparator group

Description:

Changed with new study permissions: These patients will receive placebo (2 tablets) per orally on the operation day when they arrive to the hospital and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose bosy mass index is 30 or more)in the operating theatre before the incision. The previous description: These patients will receive placebo (2 tablets) per orally in the evening 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.

Treatment:

Drug: Placebo + Cefuroxime