Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections
NCT ID: NCT05337566
Last Updated: 2024-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2278 participants
INTERVENTIONAL
2022-09-05
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Azithromycin + Cefuroxime
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.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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University of Turku
OTHER
Tampere University Hospital
OTHER
Kuopio University Hospital
OTHER
Oulu University Hospital
OTHER
Jyväskylä Central Hospital
OTHER
Helsinki University Central Hospital
OTHER
Responsible Party
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Päivi Rahkola-Soisalo
Adjuct professor, M.D.
Principal Investigators
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Päivi Rahkola-Soisalo, Adj prof, MD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Tomi Mikkola, Prof, MD
Role: STUDY_CHAIR
Helsinki University Central Hospital
Päivi Rahkola-Soisalo, Adj prof, MD
Role: STUDY_DIRECTOR
Helsinki University Central Hospital
Locations
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Helsinki University Central Hospital
Helsinki, , Finland
Jyväskylä Central Hospital
Jyväskylä, , Finland
Kuopio University Central Hospital
Kuopio, , Finland
Oulu University Central Hospital
Oulu, , Finland
Tampere University Central Hospital
Tampere, , Finland
Turku University Central Hospital
Turku, , Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-003467-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HUS/117/2022
Identifier Type: -
Identifier Source: org_study_id
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