Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05337566

Collaborator

University of Turku (Other), Tampere University Hospital (Other), Kuopio University Hospital (Other), Oulu University Hospital (Other)

2,278

Enrollment

Locations

Arms

Anticipated Duration (Months)

455.6

Patients Per Site

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infection Post Op Hysterectomy Antibiotics Prophylactic	Drug: Azithromycin Pill + Cefuroxime Drug: Placebo + Cefuroxime	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2278 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Masking Description:

single blinded - the placebo tablets slightly differ from the azithromycin tablets so participants might see the difference

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Azithromycin + Cefuroxime 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 bosy mass index is 30 or more) in the operating theatre before the incision.	Drug: Azithromycin Pill + Cefuroxime 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
Active Comparator: Placebo + Cefuroxime These patients will receive placebo (2 tablets) per orally in the evening before the operation ans 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.	Drug: Placebo + Cefuroxime Placebo (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

Arm

Intervention/Treatment

Experimental: Azithromycin + Cefuroxime

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 bosy mass index is 30 or more) in the operating theatre before the incision.

Drug: Azithromycin Pill + Cefuroxime

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

Active Comparator: Placebo + Cefuroxime

These patients will receive placebo (2 tablets) per orally in the evening before the operation ans 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.

Drug: Placebo + Cefuroxime

Placebo (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

Outcome Measures

Primary Outcome Measures

Number of post-hysterectomy episodes with deep infections [Deep infections that occur between the first and 30th postoperative day after hysterectomy]
Number of deep wound and pelvic organ infection episodes reported by patients and doctors

Secondary Outcome Measures

Number of other post-hysterectomy infections or fever episodes [Number of other infections or fever episodes that occur between the first and 30th postoperative day after hysterectomy.]
Number of superficial infections, other infections, such has urine tract infections, or fever episodes lasting over 38 ℃ over 2 days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Helsinki University Central Hospital	Helsinki	Finland
2	Kuopio University Central Hospital	Kuopio	Finland	70029
3	Oulu University Central Hospital	Oulu	Finland	PL23
4	Tampere University Central Hospital	Tampere	Finland	33521
5	Turku University Central Hospital	Turku	Finland

Sponsors and Collaborators

Helsinki University Central Hospital
University of Turku
Tampere University Hospital
Kuopio University Hospital
Oulu University Hospital

Investigators

Principal Investigator: Päivi Rahkola-Soisalo, Adj prof, MD, Helsinki University Central Hospital
Study Chair: Tomi Mikkola, Prof, MD, Helsinki University Central Hospital
Study Director: Päivi Rahkola-Soisalo, Adj prof, MD, Helsinki University Central Hospital