Against Chikungunya Virus and Neonatal Infection
Condition(s) studied
Investigational drug(s) / intervention(s)
plasma transfusion : PC-CHIK-V: 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
Study 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
Eligibility
Primary outcome measure(s)
- 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. — Five days after inclusion
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.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU La Réunion | Saint-Pierre | France | Not Yet Recruiting |
| CHU de Guyane , site de Cayenne | Cayenne | French Guiana | Recruiting |
| Centre hospitalier de Mayotte | Mamoudzou | Mayotte | Recruiting |
More Centre Hospitalier Universitaire de la Réunion trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07190560 on ClinicalTrials.gov ↗ ← All trials in France