Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2026-02-18 @ 1:20 AM
Study NCT ID:
NCT03655561
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-29
First Post:
2018-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lassa Fever Clinical Course and Prognostic Factors in Nigeria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007835', 'term': 'Lassa Fever'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D003128', 'term': 'Coma'}], 'ancestors': [{'id': 'D001117', 'term': 'Arenaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Leftover blood, urine, milk and any other bodily fluid samples. Option for genetic analyses regarding immunity against infectious diseases.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'targetDuration': '60 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2018-08-30', 'studyFirstSubmitQcDate': '2018-08-30', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall mortality', 'timeFrame': '60 days after admission (day 60 after delivery for pregnant women and day 60 after birth for newborns from infected pregnant women).', 'description': 'Mortality rate among participants assessed at final visit.'}], 'secondaryOutcomes': [{'measure': 'Acute kidney injury', 'timeFrame': 'Within 60 days after admission', 'description': 'Acute kidney injury or failure according to RIFLE criteria'}, {'measure': 'Mother status at the end of pregnancy', 'timeFrame': 'Delivery', 'description': 'Is the mother dead or alive at the end of pregnancy'}, {'measure': 'Type of pregnancy termination', 'timeFrame': 'Delivery', 'description': 'Spontaneous delivery, induced delivery, cesarean section, medical interruption, miscarriage'}, {'measure': 'Pregnancy complications', 'timeFrame': 'Delivery', 'description': 'Reporting any type of pregnancy complications'}, {'measure': 'Newborn status at birth', 'timeFrame': 'Birth', 'description': 'Is the newborn dead or alive'}, {'measure': 'Newborn status at day 30', 'timeFrame': 'Day 30 after birth', 'description': 'Is the newborn dead or alive'}, {'measure': 'Newborn status at day 60', 'timeFrame': 'Day 60 after birth', 'description': 'Is the newborn dead or alive'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lassa fever', 'Lassa virus', 'Nigeria', 'Pregnancy', 'Acute kidney injury'], 'conditions': ['Lassa Fever', 'Lassa Virus Infection', 'Pregnancy Complications', 'Acute Kidney Injury', 'Acute Kidney Failure', 'Coma']}, 'referencesModule': {'references': [{'pmid': '31978611', 'type': 'DERIVED', 'citation': "Duvignaud A, Jaspard M, Etafo IC, Serra B, Abejegah C, Gabillard D, Doutchi M, Alabi JF, Adedokun MA, Akinpelu AO, Oyegunle OO, Etafo J, Dede AO, Onyechi MN, Ireneh MU, Gbenga-Ayeni O, Fadiminiyi KG, Ehigbor PI, Ouattara E, Levy-Marchal C, Karcher S, N'guessan-Koffi L, Ahyi I, Amani E, Diabate M, Siloue B, Schaeffer J, Augier A, Ogbaini-Emovon E, Salam AP, Horby P, Ahmed LA, Gunther S, Adedosu AN, Anglaret X, Ayodeji OO, Malvy D. Lassa fever clinical course and setting a standard of care for future randomized trials: A protocol for a cohort study of Lassa-infected patients in Nigeria (LASCOPE). Travel Med Infect Dis. 2020 Jul-Aug;36:101557. doi: 10.1016/j.tmaid.2020.101557. Epub 2020 Jan 21."}]}, 'descriptionModule': {'briefSummary': 'The investigators propose to conduct a nationwide (Nigeria), prospective, non-interventional cohort study describing the clinical course, biological characteristics, case management and outcomes in patients hospitalized for a suspected or confirmed diagnosis of Lassa fever in tertiary medical facilities situated in the most affected Nigerian states. Special focuses will be made on situations at risk of bad outcome such as pregnancies, acute kidney injury and electrolytic imbalance in patients with confirmed Lassa fever. Participants for which the diagnosis of Lassa fever will be finally excluded by reverse-transcriptase polymerase chain reaction (RT-PCR) will constitute the control group.', 'detailedDescription': "The LASCOPE project refers to a nationwide, prospective, non-interventional cohort study describing the clinical course, biological characteristics, case management and outcomes in patients hospitalized for a suspected or already RT-PCR confirmed diagnosis of Lassa fever in tertiary medical facilities situated in the most affected Nigerian states. The project will start during the 2018 Lassa fever season and is intended to be extended to at least three sites throughout Nigeria on a 3 years period.\n\nThe investigators will try to depict the pathophysiological mechanisms underlying the conditions associated to a fatal outcome in patients with RT-PCR confirmed Lassa fever, with a special focus on pregnancies, acute renal injury and electrolytic imbalance.\n\nPopulation and setting - Participants will be recruited in tertiary reference hospitals for Lassa fever case management in the Nigerian States identified to have the highest burden, including Owo Federal Medical Center (OFMC), Owo, Ondo State as a pilot site (list to be completed according to the outbreak dynamics).\n\nInclusion criteria - All the patients hospitalized for suspected or already RT-PCR confirmed Lassa fever will be eligible (no age restriction). Newborns from mothers participating in the study will also be eligible.\n\nSample size - Given the descriptive purpose of the study, there is no pre-determined sample size.\n\nFollow-up - After informed consent collection, data concerning the patient's life habits, contacts, disease history, clinical and biological status, management and outcome will be collected anonymously upon admission and throughout the hospital stay. The follow-up will end 60 days after admission (60 days after delivery for pregnant women and 60 days after birth for newborns) with a phone call or a home visit (or an outpatient visit at hospital if needed).\n\nLeftover biological samples, if any, will be stored for further analysis with the participant's agreement. The biobank will be registered once constituted and further use of stored samples will be subject to material transfer agreements."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "All the patients admitted in an isolation ward of one of the participating sites (tertiary hospitals) in Nigeria for a suspected or already RT-PCR confirmed diagnosis of Lassa fever during the study period are eligible to participate in LASCOPE.\n\nThe newborns from women infected by Lassa virus (RT-PCR confirmed) during their pregnancy are also eligible to participate, with the mother's agreement.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* EITHER admission (inpatient) for suspected or already RT-PCR confirmed Lassa fever OR newborn from woman infected with Lassa virus during pregnancy\n* AND written informed consent of the patient or his/her legal representative (specific procedures for: immature minors, mature minors, incapable adults and unconscious adults; witnessed consent in case of illiteracy)\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03655561', 'acronym': 'LASCOPE', 'briefTitle': 'Lassa Fever Clinical Course and Prognostic Factors in Nigeria', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for International Medical Action'}, 'officialTitle': 'Observational Cohort Study of Lassa Fever Clinical Course and Prognostic Factors in an Epidemic Context in Nigeria', 'orgStudyIdInfo': {'id': 'LAS001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Confirmed Lassa fever cases', 'description': 'Participants with a clinical presentation consistent with acute Lassa virus disease and a positive result for Lassa specific RT-PCR obtained before or after inclusion', 'interventionNames': ['Other: Non interventional research']}, {'label': 'Non-Lassa cases (controls)', 'description': 'Participants with a clinical presentation consistent with acute Lassa virus disease but subsequently found to have a negative result for Lassa specific RT-PCR', 'interventionNames': ['Other: Non interventional research']}], 'interventions': [{'name': 'Non interventional research', 'type': 'OTHER', 'description': 'Participants are receiving the standard of care according to Nigerian Center for Disease Control (NCDC) Standard Operating Procedures for Lassa fever case management. This include the administration of intravenous ribavirin for Lassa confirmed cases as well as critically-ill Lassa suspected cases.', 'armGroupLabels': ['Confirmed Lassa fever cases', 'Non-Lassa cases (controls)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abakaliki', 'state': 'Ebonyi State', 'country': 'Nigeria', 'facility': 'Alex Ekwueme Federal University Teaching Hospital Abakaliki', 'geoPoint': {'lat': 6.32485, 'lon': 8.11368}}, {'zip': 'PMB 1053', 'city': 'Owo', 'state': 'Ondo State', 'country': 'Nigeria', 'facility': 'Owo Federal Medical Centre (Owo FMC)', 'geoPoint': {'lat': 7.1962, 'lon': 5.58681}}], 'overallOfficials': [{'name': 'Denis Malvy, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inserm 1219 - Infectious Diseases in Ressource Limited Countries'}, {'name': 'Oladele O Ayodeji, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Owo Federal Medical Centre'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Upon publication of related scientific works (undefined duration).', 'ipdSharing': 'YES', 'description': 'IPD underlying results in scientific publications will be made available through the deposition of a datafile in a public data repository.', 'accessCriteria': 'Free access.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for International Medical Action', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'University of Oxford', 'class': 'OTHER'}, {'name': 'Irrua Specialist Teaching Hospital', 'class': 'OTHER'}, {'name': 'Bernhard Nocht Institute for Tropical Medicine', 'class': 'OTHER_GOV'}, {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, {'name': 'University of Bordeaux', 'class': 'OTHER'}, {'name': 'PACCI Program', 'class': 'OTHER'}, {'name': 'Institut de Recherche pour le Developpement', 'class': 'OTHER_GOV'}, {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, {'name': 'Federal Medical Centre, Owo', 'class': 'INDUSTRY'}, {'name': 'European and Developing Countries Clinical Trials Partnership (EDCTP)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Infectious Diseases and Tropical Medicine', 'investigatorFullName': 'Denis Malvy', 'investigatorAffiliation': 'Alliance for International Medical Action'}}}}