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New treatment option for Chikungunya Virus Infection
Official title Against Chikungunya Virus and Neonatal Infection
ClinicalTrials.gov ID: NCT07190560
What this study is testing
What is plasma transfusion : PC-CHIK-V?
plasma transfusion : PC-CHIK-V is an investigational medicine, being studied as a potential treatment for chikungunya virus infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 2
You may be able to join if
- 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...
You likely can't join if
- Newborns who present at birth with clinical criteria for ahypoxic-ischemic encephalopathy (HIE) that require therapeutic hypothermia according to the...
- 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...
See the full eligibility 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...
- 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"
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Saint-Pierre, France
- Mamoudzou, Mayotte
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 days to 2 days. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint-Pierre, France; Mamoudzou, Mayotte. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.