Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT06197269
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2023-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071074', 'term': 'Neonatal Sepsis'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2023-12-26', 'studyFirstSubmitQcDate': '2023-12-26', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Incidence of 'Treatment Failure'", 'timeFrame': '15 days of stopping antibiotics', 'description': 'New onset appearance of clinical signs and symptoms requiring initiation of antibiotics'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Till 1 month of life', 'description': 'Death due to any reason'}, {'measure': 'Need for additional courses of antibiotic therapy', 'timeFrame': 'Till 1 month of life', 'description': 'Additional courses during the study time frame'}, {'measure': 'Length of hospital stay', 'timeFrame': 'From date of birth until date of death or discharge whichever come assessed till 1 month of life', 'description': 'Duration of hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Early-Onset Neonatal Sepsis', 'Antibiotic Stewardship']}, 'descriptionModule': {'briefSummary': "Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( \\>28weeks and \\>1000grams ) with culture negative early onset sepsis.", 'detailedDescription': "Enrolled participants will be randomly allocated to one of two study groups: 1) Short duration antibiotic' (72hrs), 2) Standard duration antibiotic'(5 - 7days)\n\nShort duration antibiotic group: Antibiotic therapy stopped at the time of randomization i.e. 72 hours after starting antibiotics\n\nStandard duration antibiotic group: antibiotics therapy continued for 5-7 days further after 72 hrs of starting antibiotics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Weeks', 'minimumAge': '28 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (All must be present)\n\n* All Preterm neonates (Gestational age \\>28weeks and \\>1000grams)\n* age less than 72hours of life\n* Started on antibiotic therapy based on presence of symptoms attributable to sepsis and /or positive sepsis screen but sterile blood culture\n* Symptoms resolved at time of randomization\n\nExclusion Criteria:\n\n* Antibiotics started based on risk factors\n* Infants with major congenital anomalies or syndromes.\n* Presence of site specific infections including meningitis, pneumonia\n* Neonates suspected to have inborn errors of metabolism\n* Neonates with Severe birth asphyxia, (Apgar score at 5min \\<4 and cord Ph\\< 7.0,base excess \\<-16)\n* Neonates underwent major surgery in 1st week of life\n* Deemed by Doctor in charge to be sick enough to be continued on antibiotics'}, 'identificationModule': {'nctId': 'NCT06197269', 'briefTitle': 'Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Lady Hardinge Medical College'}, 'officialTitle': 'Efficacy And Safety Of Short Course Antibiotic Therapy (72hrs) As Compared To Standard Duration (5-7 Days) Of Therapy In Preterm Neonates With Culture Negative Early Onset Sepsis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LHMC/IEC/2019/41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short duration antibiotic', 'description': 'antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment', 'interventionNames': ['Other: Short duration antibiotics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard duration antibiotic', 'description': 'Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment.', 'interventionNames': ['Other: Standard duration antibiotics']}], 'interventions': [{'name': 'Short duration antibiotics', 'type': 'OTHER', 'description': 'antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment', 'armGroupLabels': ['Short duration antibiotic']}, {'name': 'Standard duration antibiotics', 'type': 'OTHER', 'description': 'Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment.', 'armGroupLabels': ['Standard duration antibiotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Lady Hardinge Medical college', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lady Hardinge Medical College', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Professor & Head, Department of Neonatology', 'investigatorFullName': 'Sushma Nangia, M.D.', 'investigatorAffiliation': 'Lady Hardinge Medical College'}}}}