Using azithromycin before hysterectomy to reduce infections
Infections After Hysterectomy - a Placebo-controlled Study Comparing the Prophylactic Use of Azithromycin and Cefuroxime With Single Cefuroxime
This study is testing if giving women azithromycin before a hysterectomy can help reduce the chance of getting infections after the surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2278 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 6 sites (Helsinki and 5 other locations) |
| Trial ID | NCT05337566 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women undergoing hysterectomy for benign indications who do not have contraindications for azithromycin or cefuroxime.
Not a fit: Patients with allergies to cefuroxime or azithromycin, or those with certain cardiac conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of infections after hysterectomy, improving patient outcomes and reducing healthcare costs.
How similar studies have performed: Other studies have shown promise in using prophylactic antibiotics to reduce postoperative infections, making this approach a potentially viable option.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Helsinki and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.