Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-01 @ 6:32 PM
Study NCT ID:
NCT05337566
Status:
RECRUITING
Last Update Posted:
2024-08-21
First Post:
2022-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D002444', 'term': 'Cefuroxime'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'single blinded - the placebo tablets slightly differ from the azithromycin tablets, therefore they are sealed in package which is given straight to the participant'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2278}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2022-04-14', 'studyFirstSubmitQcDate': '2022-04-14', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of post-hysterectomy episodes with deep infections', 'timeFrame': 'Deep infections that occur between the first and 30th postoperative day after hysterectomy', 'description': 'Number of deep wound and pelvic organ infection episodes reported by patients and doctors'}], 'secondaryOutcomes': [{'measure': 'Number of other post-hysterectomy infections or fever episodes', 'timeFrame': 'Number of other infections or fever episodes that occur between the first and 30th postoperative day after hysterectomy.', 'description': 'Number of superficial infections, other infections, such has urine tract infections, or fever episodes lasting over 38 ℃ over 2 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative, infection, hysterectomy, antibiotics'], 'conditions': ['Infection Post Op', 'Hysterectomy', 'Antibiotics', 'Prophylactic']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Inability to understand the study protocol.\n* Allergy for either cefuroxime or azithromycin.\n* 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,\n* Electrocardiogram will be checked for all the participants.\n* 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).\n* Use of selective serotonin reuptake inhibitor medication and prolonged Q-T-corrected interval.'}, 'identificationModule': {'nctId': 'NCT05337566', 'briefTitle': 'Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Infections After Hysterectomy - a Placebo-controlled Study Comparing the Prophylactic Use of Azithromycin and Cefuroxime With Single Cefuroxime', 'orgStudyIdInfo': {'id': 'HUS/117/2022'}, 'secondaryIdInfos': [{'id': '2021-003467-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azithromycin + Cefuroxime', 'description': 'Changed with renewed study permissions:\n\nThese 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.\n\nThe previous description:\n\nThese 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.', 'interventionNames': ['Drug: Azithromycin Pill + Cefuroxime']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + Cefuroxime', 'description': 'Changed with new study permissions:\n\nThese 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.\n\nThe previous description:\n\nThese 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.', 'interventionNames': ['Drug: Placebo + Cefuroxime']}], 'interventions': [{'name': 'Azithromycin Pill + Cefuroxime', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Azithromycin + Cefuroxime']}, {'name': 'Placebo + Cefuroxime', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Placebo + Cefuroxime']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Päivi K Rahkola-Soisalo, Adj prof,MD', 'role': 'CONTACT', 'email': 'paivi.rahkola-soisalo@hus.fi', 'phone': '+358 50 4270411'}, {'name': 'Ninja Savonius, MD', 'role': 'CONTACT', 'email': 'ninja.savonius@hus.fi', 'phone': '+358503466986'}, {'name': 'Liisu Saavalainen, PhD, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Päivi Härkki, Adj prof, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tomi Mikkola, Prof, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Veli-Jukka Anttila, Adj prof,MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Seppo Virtanen, DI, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anne Saloranta, Adj Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ilkka Kalliala, Adj Prof, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Suvi Niku, PhD, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '40620', 'city': 'Jyväskylä', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Jaana Seikkula, PhD', 'role': 'CONTACT', 'email': 'jaana.seikkula@fimnet.fi', 'phone': '+358 41 548 3562'}], 'facility': 'Jyväskylä Central Hospital', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'zip': '70029', 'city': 'Kuopio', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Henna Kärkkäinen, PhD', 'role': 'CONTACT', 'email': 'henna.karkkainen@kuh.fi', 'phone': '+358 44 7172741'}], 'facility': 'Kuopio University Central Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': 'PL23', 'city': 'Oulu', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Sari Koivurova, PhD', 'role': 'CONTACT', 'email': 'sari.koivurova@ppshp.fi', 'phone': '+358 8 3150211'}], 'facility': 'Oulu University Central Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '33521', 'city': 'Tampere', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Riikka Niemi, PhD', 'role': 'CONTACT', 'email': 'riikka.niemi@pshp.fi', 'phone': '+358 3 31169083'}, {'name': 'Elina Ylilehto, PhD, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tampere University Central Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Pia Heinonen, PhD', 'role': 'CONTACT', 'email': 'pia.heinonen@tyks.fi', 'phone': '+358 2 313 5002'}], 'facility': 'Turku University Central Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'centralContacts': [{'name': 'Päivi K Rahkola-Soisalo, Adj prof,MD', 'role': 'CONTACT', 'email': 'paivi.rahkola-soisalo@hus.fi', 'phone': '+358504270411'}, {'name': 'Ninja Savonius, MD', 'role': 'CONTACT', 'email': 'ninja.savonius@hus.fi', 'phone': '+358503466986'}], 'overallOfficials': [{'name': 'Päivi Rahkola-Soisalo, Adj prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}, {'name': 'Tomi Mikkola, Prof, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Helsinki University Central Hospital'}, {'name': 'Päivi Rahkola-Soisalo, Adj prof, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Turku', 'class': 'OTHER'}, {'name': 'Tampere University Hospital', 'class': 'OTHER'}, {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, {'name': 'Oulu University Hospital', 'class': 'OTHER'}, {'name': 'Jyväskylä Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjuct professor, M.D.', 'investigatorFullName': 'Päivi Rahkola-Soisalo', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}