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Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

Primary Purpose

Infection Post Op, Hysterectomy, Antibiotics

Status

Recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Azithromycin Pill + Cefuroxime

Placebo + Cefuroxime

About this trial

This is an interventional prevention trial for Infection Post Op focused on measuring postoperative, infection, hysterectomy, antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Azithromycin + Cefuroxime

Placebo + Cefuroxime

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

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.

Outcomes

Primary Outcome Measures

Number of post-hysterectomy episodes with deep infections

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 superficial infections, other infections, such has urine tract infections, or fever episodes lasting over 38 ℃ over 2 days

Full Information

NCT ID

NCT05337566

First Posted

April 14, 2022

Last Updated

September 5, 2022

Sponsor

Helsinki University Central Hospital

Collaborators

University of Turku, Tampere University Hospital, Kuopio University Hospital, Oulu University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05337566

Brief Title

Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 5, 2022 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helsinki University Central Hospital

Collaborators

University of Turku, Tampere University Hospital, Kuopio University Hospital, Oulu University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infection Post Op, Hysterectomy, Antibiotics, Prophylactic

Keywords

postoperative, infection, hysterectomy, antibiotics

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

2278 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Azithromycin + Cefuroxime

Arm Type

Experimental

Arm Description

Arm Title

Placebo + Cefuroxime

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Azithromycin Pill + Cefuroxime

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo + Cefuroxime

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of post-hysterectomy episodes with deep infections

Description

Number of deep wound and pelvic organ infection episodes reported by patients and doctors

Time Frame

Deep infections that occur between the first and 30th postoperative day after hysterectomy

Secondary Outcome Measure Information:

Title

Number of other post-hysterectomy infections or fever episodes

Description

Number of superficial infections, other infections, such has urine tract infections, or fever episodes lasting over 38 ℃ over 2 days

Time Frame

Number of other infections or fever episodes that occur between the first and 30th postoperative day after hysterectomy.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Päivi K Rahkola-Soisalo, Adj prof,MD

Phone

+358504270411

paivi.rahkola-soisalo@hus.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Ninja Savonius, MD

Phone

+358503466986

ninja.savonius@hus.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Päivi Rahkola-Soisalo, Adj prof, MD

Organizational Affiliation

Helsinki University Central Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tomi Mikkola, Prof, MD

Organizational Affiliation

Helsinki University Central Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Päivi Rahkola-Soisalo, Adj prof, MD

Organizational Affiliation

Helsinki University Central Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Helsinki University Central Hospital

City

Helsinki

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Päivi K Rahkola-Soisalo, Adj prof,MD

Phone

+358 50 4270411

paivi.rahkola-soisalo@hus.fi

First Name & Middle Initial & Last Name & Degree

Ninja Savonius, MD

Phone

+358503466986

ninja.savonius@hus.fi

First Name & Middle Initial & Last Name & Degree

Liisu Saavalainen, PhD, MD

First Name & Middle Initial & Last Name & Degree

Päivi Härkki, Adj prof, MD

First Name & Middle Initial & Last Name & Degree

Tomi Mikkola, Prof, MD

First Name & Middle Initial & Last Name & Degree

Veli-Jukka Anttila, Adj prof,MD

First Name & Middle Initial & Last Name & Degree

Seppo Virtanen, DI, MD

First Name & Middle Initial & Last Name & Degree

Anne Saloranta, Adj Prof

First Name & Middle Initial & Last Name & Degree

Ilkka Kalliala, Adj Prof, MD

Facility Name

Kuopio University Central Hospital

City

Kuopio

ZIP/Postal Code

70029

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Henna Kärkkäinen, PhD

Phone

+358 44 7172741

henna.karkkainen@kuh.fi

Facility Name

Oulu University Central Hospital

City

Oulu

ZIP/Postal Code

PL23

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sari Koivurova, PhD

Phone

+358 8 3150211

sari.koivurova@ppshp.fi

Facility Name

Tampere University Central Hospital

City

Tampere

ZIP/Postal Code

33521

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Riikka Niemi, PhD

Phone

+358 3 31169083

riikka.niemi@pshp.fi

Facility Name

Turku University Central Hospital

City

Turku

Country

Finland

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pia Heinonen, PhD

Phone

+358 2 313 5002

pia.heinonen@tyks.fi

12. IPD Sharing Statement

Plan to Share IPD

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Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

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