Against Chikungunya Virus and Neonatal Infection (NCT07190560) | Clinical Trial Compass
RecruitingNot Applicable
Against Chikungunya Virus and Neonatal Infection
France, Mayotte60 participantsStarted 2026-08-01
Plain-language summary
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
Who can participate
Age range
0 Days – 2 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Treatment group
Newborn:
* whose mother has a clinical and/or laboratory diagnosis of Chikungunya (CHIK) infection occurring between 2 days before and 2 days after birth.
* Hospitalized in a Level III neonatology unit in Mayotte or at the University Hospital of La Réunion.
* Eligible for experimental treatment (called PC-CHIK-V):
* 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.
* If the maternal infection was diagnosed between 1 day and 2 days after birth, treatment can be administered within 12 hours of diagnosis.
* Whose holders of parental authority have given free, informed, and written consent prior to any examination required for the research. Parallel Cohort of
Untreated Newborns (parallel observational cohort)
Newborns:
* Whose mother has a clinical and/or laboratory diagnosis of CHIK-V infection occurring between 2 days before and 2 days after birth.
* Hospitalized in a Level III neonatology unit in Mayotte or at the University Hospital of La Réunion.
* Not treated with PC-CHIK-V:
* Monitored in one of the units of the Neonatology Department for at least 5 days from the day of birth.
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Trial details
NCT IDNCT07190560
SponsorCentre Hospitalier Universitaire de la Réunion