Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

NCT05337566 | Recruiting

• 2 other identifiers: HUS/117/20222021-003467-10
• Study Type: interventional
• Target: 2,278
• Locations: 1 country
• Sites: 6

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.

Conditions

Infection Post Op; Hysterectomy; Antibiotics; Prophylactic

Keywords

postoperative, infection, hysterectomy, antibiotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Azithromycin + Cefuroxime

EXPERIMENTAL

Changed with renewed study permissions: These patients will receive Azithromycin 500 mg (2 tablets) per orally on the operation day when they arrive to the hospital and a 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. The previous description: 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 body mass index is 30 or more) in the operating theatre before the incision.

Drug: Azithromycin Pill + Cefuroxime

Placebo + Cefuroxime

ACTIVE COMPARATOR

Changed with new study permissions: These patients will receive placebo (2 tablets) per orally on the operation day when they arrive to the hospital and a 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. The previous description: These patients will receive placebo (2 tablets) per orally in the evening 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.

Drug: Placebo + Cefuroxime

Interventions

Azithromycin Pill + Cefuroxime DRUG

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

Azithromycin + Cefuroxime

Placebo + Cefuroxime DRUG

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

Placebo + Cefuroxime

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Turku: collaborator
• Tampere University Hospital: collaborator
• Kuopio University Hospital: collaborator
• Oulu University Hospital: collaborator
• Jyväskylä Central Hospital: collaborator

Study Sites (6)

Helsinki University Central Hospital

Helsinki, Finland

RECRUITING

Jyväskylä Central Hospital

Jyväskylä, 40620, Finland

RECRUITING

Kuopio University Central Hospital

Kuopio, 70029, Finland

RECRUITING

Oulu University Central Hospital

Oulu, PL23, Finland

RECRUITING

Tampere University Central Hospital

Tampere, 33521, Finland

RECRUITING

Turku University Central Hospital

Turku, Finland

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Azithromycin; Cefuroxime

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Päivi Rahkola-Soisalo, Adj prof, MD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

• Tomi Mikkola, Prof, MD

  Helsinki University Central Hospital

  STUDY CHAIR

• Päivi Rahkola-Soisalo, Adj prof, MD

  Helsinki University Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Päivi K Rahkola-Soisalo, Adj prof,MD

CONTACT

+358504270411; paivi.rahkola-soisalo@hus.fi

Ninja Savonius, MD

CONTACT

+358503466986; ninja.savonius@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: single blinded - the placebo tablets slightly differ from the azithromycin tablets, therefore they are sealed in package which is given straight to the participant
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjuct professor, M.D.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 20, 2022
• Study Start: September 5, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (6)