Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

Hysterectomy Clinical Trial

Official title:

Infections After Hysterectomy - a Placebo-controlled Study Comparing the Prophylactic Use of Azithromycin and Cefuroxime With Single Cefuroxime

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05337566
• Other study ID #: HUS/117/2022
• Secondary ID: 2021-003467-10
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: December 2030

Study information

• Verified date: November 2023
• Source: Helsinki University Central Hospital
• Contact: Päivi K Rahkola-Soisalo, Adj prof,MD
• Phone: +358504270411
• Email: paivi.rahkola-soisalo[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2278
• Est. completion date: December 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotics
• Communicable Diseases
• Hysterectomy
• Infection Post Op
• Infections

Intervention

Drug:
• Azithromycin Pill + Cefuroxime
Azithromycin 500 mg (2 tablets) per orally when arriving to the hospital 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
• Placebo + Cefuroxime
Placebo (2 tablets) per orally in the evening when arriving to the hospital 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

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
Finland	Kuopio University Central Hospital	Kuopio
Finland	Oulu University Central Hospital	Oulu
Finland	Tampere University Central Hospital	Tampere
Finland	Turku University Central Hospital	Turku

Sponsors (5)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Kuopio University Hospital, Oulu University Hospital, Tampere University Hospital, University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of post-hysterectomy episodes with deep infections	Number of deep wound and pelvic organ infection episodes reported by patients and doctors	Deep infections that occur between the first and 30th postoperative day after hysterectomy
Secondary	Number of other post-hysterectomy infections or fever episodes	Number of superficial infections, other infections, such has urine tract infections, or fever episodes lasting over 38 ? over 2 days	Number of other infections or fever episodes that occur between the first and 30th postoperative day after hysterectomy.