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Against Chikungunya Virus and Neonatal Infection

Study acronym: ConvictionCHIK
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Oct 1, 2027 → Oct 1, 2028
See other at-risk trials from Centre Hospitalier Universitaire de la Réunion

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Oct 1, 2027 to Oct 1, 2028 Show 6 more changesShow less
    • Start date: Aug 1, 2026 to Aug 1, 2027
    • Primary endpoints: details revised at 1 of 1 entry
    • Study completion pushed from Dec 1, 2027 to Dec 1, 2029
    • Study sites: 2 to 3
    • Eligibility criteria expanded, about 14 words
    • Publications: details revised at 1 of 1 entry
  2. Recruitment opened
    • Start date: Apr 1, 2026 to Aug 1, 2026
    • Study sites: 1 to 2
    v4
  3. Primary completion date: Apr 1, 2027 to Oct 1, 2027
    • Start date: Nov 1, 2025 to Apr 1, 2026
    • Study completion date: Apr 1, 2027 to Dec 1, 2027
    v3
  4. Eligibility criteria expanded, about 12 wordsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. Participants of the clinical trial will: * receive a transfusion, * visit the clinic and undergo biological tests every day until day 7 and once between 1 and 3 months. Participant 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
Trial Details
NCT Number NCT07190560
Lead Sponsor Centre Hospitalier Universitaire de la Réunion
Conditions
(from sponsor)		 Chikungunya Virus Infection, Neonatal, Transfusion, Encephalopathy
Related terms Brain Diseases, Chikungunya Fever
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov