Status:
UNKNOWN
Clinical Evaluation of Anti-CHIKV Hyperimmune Intravenous Immunoglobulins
Lead Sponsor:
Centre Hospitalier Universitaire de la Guadeloupe
Conditions:
Chikungunya Virus Infection
Eligibility:
All Genders
Up to 72 years
Phase:
PHASE1
PHASE2
Brief Summary
Chikungunya virus (CHIKV) has been detected in humans in the Caribbean area for the first time in November 2013 (St-Martin Island). By February 2014, the virus had spread to several other Caribbean is...
Detailed Description
The population to be studied will consist of neonates born to mothers presenting with clinical symptoms of Chikungunya within six days before and two days after childbirth. These neonates will therefo...
Eligibility Criteria
Inclusion
- 1\. Inclusion criteria in mothers:
- Clinical symptoms consistent with CHIKV infection (acute-onset high-grade fever combined with bilateral polyarthralgia and no other cause than Chikungunya) during the pre-partum period or within the 48 hours post-partum,
- Written informed consent obtained,
- Negative Dengue fever rapid diagnostic test,
- Blood sampled for CHIKV RT-PCR, processed in emergency, to be used to define 3 diagnosis categories at neonate's birth:
- positive: definite maternal CHIKV infection,
- pending: probable maternal CHIKV infection,
- negative: maternal CHIKV infection excluded.
- 2\. Inclusion criteria in neonates:
- Neonate born to a mother fulfilling ALL maternal inclusion criteria and NO maternal exclusion criteria,
- Written informed consent signed by both neonate's parents (or legal guardians).
Exclusion
- 1\. Exclusion criteria in mothers:
- Delivery more than 6 days after the onset of first symptoms of CHIKV infection,
- Maternal CHIKV infection excluded,
- Chronic active HBV infection (positive HBs Ag),
- HIV infection.
- 2\. Exclusion criteria in neonates:
- Preterm neonate below 28 weeks of gestational age.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02230163
Start Date
September 1 2014
End Date
April 1 2016
Last Update
November 3 2014
Active Locations (3)
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1
Centre Hospitalier de la Basse-Terre
Basse-Terre, Guadeloupe, France, 97109
2
Centre Hospitalier de Cayenne "Andrée ROSEMON"
Cayenne, Guyane, France, 97306
3
CHU de Martinique
Fort-de-France, Martinique, France, 97261