Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
Study NCT ID:
NCT07190560
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Against Chikungunya Virus and Neonatal Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065632', 'term': 'Chikungunya Fever'}, {'id': 'D001927', 'term': 'Brain Diseases'}], 'ancestors': [{'id': 'D018354', 'term': 'Alphavirus Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-09-17', 'studyFirstSubmitQcDate': '2025-09-17', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the efficacy of early administration of PC-CHIK-V in preventing the occurrence of neonatal CHIK-V encephalitis/encephalopathy (EE) in newborns whose mothers have peripartum CHIK-V infection.', 'timeFrame': 'Five days after inclusion', 'description': 'The primary outcome measure is the proportion of newborns treated with PC-CHIK-V surviving without encephalitis/encephalopathy (EE) within the first 5 days of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chikungunya Virus Infection', 'Neonatal', 'Transfusion', 'Encephalopathy']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn if administration of plasma, from a whole blood donation from an individual who has declared a Chikungunya infection for less than 6 months , to a newborn, whose mother has a peripartum chikungunya infection, will have an impact on the proportion of newborns surviving without encephalitis/encephalopathy (EE) within the first 5 days of life. Researchers will compare results to an observational study of 30 newborns who couldn't have been proposed to participate at the clinical trial, because of delay of diagnosis or delay of transfer to hospital which doesn't allow transfusion or parents not accepting plasma transfusion to the newborn.\n\nParticipants of the clinical trial will:\n\n* receive a transfusion,\n* visit the clinic and undergo biological tests every day until day 7 and once between 1 and 3 months.\n\nParticipant of observational study as part of their regular medical care, and biological data will be reused for the research from the mother's diagnosis until the newborn reaches 3 months of age"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Days', 'minimumAge': '0 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment group\n\nNewborn:\n\n* whose mother has a clinical and/or laboratory diagnosis of Chikungunya (CHIK) infection occurring between 2 days before and 2 days after birth.\n* Hospitalized in a Level III neonatology unit in Mayotte or at the University Hospital of La Réunion.\n* Eligible for experimental treatment (called PC-CHIK-V):\n\n * If the maternal infection was diagnosed between2 days before and the day of delivery, treatment can be administered within the first 12 hours of the newborn\'s life.\n * If the maternal infection was diagnosed between 1 day and 2 days after birth, treatment can be administered within 12 hours of diagnosis.\n* Whose holders of parental authority have given free, informed, and written consent prior to any examination required for the research. Parallel Cohort of\n\nUntreated Newborns (parallel observational cohort)\n\nNewborns:\n\n* Whose mother has a clinical and/or laboratory diagnosis of CHIK-V infection occurring between 2 days before and 2 days after birth.\n* Hospitalized in a Level III neonatology unit in Mayotte or at the University Hospital of La Réunion.\n* Not treated with PC-CHIK-V:\n* Monitored in one of the units of the Neonatology Department for at least 5 days from the day of birth.\n* Whose holders of parental authority (or the holder if the mother is the sole holder of parental authority) have been informed of the research and have not objected to the use of data collected during hospitalization for research purposes.\n\nExclusion Criteria:\n\n* Newborns who present at birth with clinical criteria for ahypoxic-ischemic encephalopathy (HIE) that require therapeutic hypothermia according to the national protocol for "neonatal therapeutic hypothermia"\n* Newborns who require phototherapy treatment at the time of enrollment using devices with a maximum energy wavelength less than 425 nm and/or with an emission bandwidth with a lower limit of \\<375 nm.'}, 'identificationModule': {'nctId': 'NCT07190560', 'acronym': 'ConvictionCHIK', 'briefTitle': 'Against Chikungunya Virus and Neonatal Infection', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Against Chikungunya Virus and Neonatal Infection', 'orgStudyIdInfo': {'id': '2025/RUN/0036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Plasma transfusion in newborns whose mothers are infected with chikungunya around the time of birth.', 'description': 'Biological and medical examination from Day 1 to Day 7 and at a visit between 1 and 3 months', 'interventionNames': ['Biological: plasma transfusion : PC-CHIK-V']}, {'type': 'NO_INTERVENTION', 'label': 'Parallel observational cohort', 'description': 'No intervention, secondary using of care data collected, during standard cares, for the research'}], 'interventions': [{'name': 'plasma transfusion : PC-CHIK-V', 'type': 'BIOLOGICAL', 'description': 'plasma transfusion , from donation from an individual who has declared a Chikungunya infection for less than 6 months , to a newborn, whose mother has a peripartum chikungunya infection', 'armGroupLabels': ['Plasma transfusion in newborns whose mothers are infected with chikungunya around the time of birth.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97410', 'city': 'Saint-Pierre', 'country': 'France', 'contacts': [{'name': 'IACOBELLI', 'role': 'CONTACT', 'email': 'promotion.drci@chu-reunion.fr', 'phone': '+262262359000'}, {'name': 'Duksha RAMFUL, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Soumeth ABASSE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Silvia IACOBELLI, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU La Réunion', 'geoPoint': {'lat': 43.29282, 'lon': 5.40682}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}