Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-25 @ 9:49 PM
Study NCT ID:
NCT03721302
Status:
COMPLETED
Last Update Posted:
2020-08-19
First Post:
2018-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NeoAMR Observational Study in Neonatal 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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Microbiological isolates'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3202}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-17', 'studyFirstSubmitDate': '2018-10-04', 'studyFirstSubmitQcDate': '2018-10-22', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality Rate', 'timeFrame': '28 days', 'description': 'To estimate mortality rates in hospitalised infants less than 60 days of age who are being treated for significant sepsis (where significant is defined as presenting with 2 or more of the signs /symptoms listed in the inclusion criteria).'}], 'secondaryOutcomes': [{'measure': 'To determine the microbiological epidemiology, including antimicrobial susceptibility and resistance mechanisms, in infants with positive blood and/or cerebrospinal fluid culture', 'timeFrame': '28 days', 'description': 'The incidence of culture positive and culture negative sepsis (both bloodstream and CSF isolates)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal SEPSIS']}, 'referencesModule': {'references': [{'pmid': '29025624', 'type': 'BACKGROUND', 'citation': 'Folgori L, Ellis SJ, Bielicki JA, Heath PT, Sharland M, Balasegaram M. Tackling antimicrobial resistance in neonatal sepsis. Lancet Glob Health. 2017 Nov;5(11):e1066-e1068. doi: 10.1016/S2214-109X(17)30362-5. No abstract available.'}, {'pmid': '37289666', 'type': 'DERIVED', 'citation': 'Russell NJ, Stohr W, Plakkal N, Cook A, Berkley JA, Adhisivam B, Agarwal R, Ahmed NU, Balasegaram M, Ballot D, Bekker A, Berezin EN, Bilardi D, Boonkasidecha S, Carvalheiro CG, Chami N, Chaurasia S, Chiurchiu S, Colas VRF, Cousens S, Cressey TR, de Assis ACD, Dien TM, Ding Y, Dung NT, Dong H, Dramowski A, Ds M, Dudeja A, Feng J, Glupczynski Y, Goel S, Goossens H, Hao DTH, Khan MI, Huertas TM, Islam MS, Jarovsky D, Khavessian N, Khorana M, Kontou A, Kostyanev T, Laoyookhon P, Lochindarat S, Larsson M, Luca M, Malhotra-Kumar S, Mondal N, Mundhra N, Musoke P, Mussi-Pinhata MM, Nanavati R, Nakwa F, Nangia S, Nankunda J, Nardone A, Nyaoke B, Obiero CW, Owor M, Ping W, Preedisripipat K, Qazi S, Qi L, Ramdin T, Riddell A, Romani L, Roysuwan P, Saggers R, Roilides E, Saha SK, Sarafidis K, Tusubira V, Thomas R, Velaphi S, Vilken T, Wang X, Wang Y, Yang Y, Zunjie L, Ellis S, Bielicki JA, Walker AS, Heath PT, Sharland M. Patterns of antibiotic use, pathogens, and prediction of mortality in hospitalized neonates and young infants with sepsis: A global neonatal sepsis observational cohort study (NeoOBS). PLoS Med. 2023 Jun 8;20(6):e1004179. doi: 10.1371/journal.pmed.1004179. eCollection 2023 Jun.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, multinational, multicentre, observational cohort study of neonatal sepsis in partner institutions. The cohort study will be designed to evaluate health care utilization and current clinical practice and to assess risk factors for and outcomes of babies with neonatal sepsis (culture-negative and culture-positive).', 'detailedDescription': '1. NeoSEPSIS: Consecutive hospitalized babies with neonatal sepsis will be recruited and followed up until discharge from hospital or death (for a maximum of 28 days). A minimal neonatal sepsis dataset will determine (i) clinical presentations, associated features and risk factors (for example prematurity, SGA (small for gestational age)), (ii) rates of culture-positivity among babies with sepsis, (iii) current empirical treatment approaches (antimicrobials selected, dose, etc) (iv) outcomes of sepsis, including death, need for intensive care interventions and recurrence of sepsis during the follow-up period. Microbiological samples will be taken from sterile sites, blood and CSF, as clinically indicated and will be processed locally.\n2. NeoBSI: Consecutive babies with positive blood/CSF cultures and sepsis will be recruited. Patient inclusion will be based on identification of relevant specified bacteria from blood / CSF cultures. In addition to the data collected for NeoSEPSIS, information will be collected on the isolates and their antimicrobial susceptibility patterns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized Babies with significant sepsis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In-patient in the hospital (NNU (Neonatal unit) or paediatric ward) of one of the partner institutions\n\n * Age \\<60 days of age\n * Clinical suspicion of a new episode of sepsis (as defined below)\\*\\* together with planned treatment with IV antibiotics OR new episode of confirmed bacterial meningitis\\^ OR new episode of infection in which a Carbapenem-resistant organism (CRO) is isolated from blood culture OR new episode of infection in which a candida species is isolated from blood culture\n * Informed consent from parent / guardian\n * Willingness to provide location information and to be contacted at 28 days from start of antibiotic treatment\n\nExclusion Criteria:\n\n* • Previously enrolled in this study, unless readmitted and re-started on antibiotics before the 28 day follow-up limit is reached\n\n * Enrollment in any interventional trial\n * A serious, non-infective co-morbidity (other than prematurity), anticipated to cause death within 72 hours'}, 'identificationModule': {'nctId': 'NCT03721302', 'briefTitle': 'NeoAMR Observational Study in Neonatal Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Drugs for Neglected Diseases'}, 'officialTitle': 'A Prospective, Multinational, Observational, Cohort Study Sepsis in Hospitalised Neonates in Areas With High Endemic Levels of Antimicrobial Resistance.', 'orgStudyIdInfo': {'id': 'NeoOBS 001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Main Study Clinical Sepsis', 'description': 'Clinical and Antimicrobial Assessments', 'interventionNames': ['Other: Main study clinical sepsis']}, {'label': 'Microbiology Sub study', 'description': 'Clinical and Antimicrobial Assessments', 'interventionNames': ['Other: Main study clinical sepsis', 'Other: Microbiology sub study']}], 'interventions': [{'name': 'Main study clinical sepsis', 'type': 'OTHER', 'description': 'No intervention-Observational study', 'armGroupLabels': ['Main Study Clinical Sepsis', 'Microbiology Sub study']}, {'name': 'Microbiology sub study', 'type': 'OTHER', 'description': 'Analysis of Bacterial isolates', 'armGroupLabels': ['Microbiology Sub study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'Dhaka Shishu Hospital', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'FCM da Santa Casa de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Children Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Obstetrics and Gynecology Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shenzhen', 'country': 'China', 'facility': 'Shenzhen Children Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Hippokration Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Mumbai', 'country': 'India', 'facility': 'King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'New Delhi', 'country': 'India', 'facility': 'Lady Hardinge Medical College', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'city': 'Puducherry', 'country': 'India', 'facility': 'Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)', 'geoPoint': {'lat': 11.93381, 'lon': 79.82979}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Bambino Gesu Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Kilifi', 'country': 'Kenya', 'facility': 'KEMRI/Wellcome Trust Research Programme', 'geoPoint': {'lat': -3.63045, 'lon': 39.84992}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Tygerberg Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Charlotte Maxeke', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Chris Hani Baragwanath Academic Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Queen Sirikit National Institute of Child Health', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Chiang Rai', 'country': 'Thailand', 'facility': 'Chiang Rai Prachanukroh Hospital', 'geoPoint': {'lat': 19.90858, 'lon': 99.8325}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'Mulago Hospital', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Vietnam National Hospital of Paediatrics', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'overallOfficials': [{'name': 'Mike Sharland', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. George's Hospital, University of London"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Drugs for Neglected Diseases', 'class': 'OTHER'}, 'collaborators': [{'name': "St George's, University of London", 'class': 'OTHER'}, {'name': 'PENTA Foundation', 'class': 'NETWORK'}, {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}