Using azithromycin before hysterectomy to reduce infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether the preoperative administration of azithromycin, in addition to the standard antibiotic cefuroxime, can decrease the incidence of post-hysterectomy infections. The primary aim is to compare the rates of infections in women undergoing hysterectomy for benign reasons who receive either azithromycin or a placebo alongside cefuroxime. Secondary outcomes include the assessment of superficial infections, urinary tract infections, postoperative fever, and potential side effects of the antibiotics. The study also explores the relationship between bacterial vaginosis, microbiome, and post-hysterectomy infections.

Why it matters

Who can join: the full rules

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.

Where it's running

• Helsinki University Central Hospital
  Helsinki, Finland Recruiting
• Jyväskylä Central Hospital
  Jyväskylä, Finland Recruiting
• Kuopio University Central Hospital
  Kuopio, Finland Recruiting
• Oulu University Central Hospital
  Oulu, Finland Recruiting
• Tampere University Central Hospital
  Tampere, Finland Recruiting
• Turku University Central Hospital
  Turku, Finland Recruiting

Study contacts

• Principal investigator: Päivi Rahkola-Soisalo, Adj prof, MD — Helsinki University Central Hospital
• Study coordinator: Päivi K Rahkola-Soisalo, Adj prof,MD
• Email: paivi.rahkola-soisalo@hus.fi
• Phone: +358504270411

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.