Infections after hysterectomy - a double blinded placebo controlled study comparing the profylactic use of azithromycin and cefuroxime with single cefuroxime

Phase 1

• Conditions: Post-hysterectomy infections; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2021-003467-10-FI
• Lead Sponsor: HUS Naistenklinikka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-29
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 2000

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1550
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 700

Exclusion Criteria

Inability to understand the study protocol.

Allergy for either cefuroxime or azithromycin.

Congenital or acquired prolonged QTc interval. All the participants will be asked about arrhythmias and whether they have congenital arrhythmias in the family.

ECG will be checked for all the participants.

Use of medicines that may prolong QTc interval (class Ia arrhythmia medications, quinidine, procainamide, and class III arrhythmia medications dofetilidi, amiodarone and sotalol).

Use of SSRI medication and prolonged QTc interval.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified