Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT03922594
Status:
TERMINATED
Last Update Posted:
2022-05-20
First Post:
2019-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia
Sponsor:
Institut Pasteur
Organization:
Study Overview
Official Title:
Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The disruptions due to the impact of the ongoing COVID-19 pandemic to the implementation of the study in each of the study sites, as well as to the coordination of the study at Institut Pasteur, prevented the completion of the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will explore whether ZIKV is currently responsible for neurological complications, and particularly microcephaly, in Aedes-infested regions of Sub-Saharan Africa (SSA) and Asia. This will inform regional public health strategies, such as vaccination of women of child-bearing age. It will also demonstrate the public health impact of ZIKV infection and increase the understanding of other regional infectious (e.g. cytomegalovirus) causes of microcephaly.
Detailed Description:
This study will last for 2 years, and will include only new cases of microcephaly.
Surveillance will take place in large maternities in urban areas (standard procedure)
* In each city, \~3000 live births per month will be monitored, so that on average one microcephaly will be diagnosed per month per city (i.e., 24 per city in 2 years)
* Microcephaly is defined as less than -3 standard deviation (SD), according to the INTERGROWTH standards by age and sex with abnormal ultrasound and/or clinical examination.
Data collection (study activity)
* A questionnaire with demographic, exposure and pregnancy details for all mothers Clinical exam and laboratory testing (standard procedure and study activity)
* Various biological samples (e.g. blood, placenta) will be collected from mothers and newborns/fetuses and tested for presence of ZIKV, and for other infectious (e.g. rubella, cytomegalovirus) causes of microcephaly
* Physical, neurological, hearing and visual examinations for all live births will be performed where possible.
Analysis and reporting (study activity)
o All results will be shared publically through conferences and peer-reviewed publications.
Surveillance will take place in large maternities in urban areas (standard procedure)
* In each city, \~3000 live births per month will be monitored, so that on average one microcephaly will be diagnosed per month per city (i.e., 24 per city in 2 years)
* Microcephaly is defined as less than -3 standard deviation (SD), according to the INTERGROWTH standards by age and sex with abnormal ultrasound and/or clinical examination.
Data collection (study activity)
* A questionnaire with demographic, exposure and pregnancy details for all mothers Clinical exam and laboratory testing (standard procedure and study activity)
* Various biological samples (e.g. blood, placenta) will be collected from mothers and newborns/fetuses and tested for presence of ZIKV, and for other infectious (e.g. rubella, cytomegalovirus) causes of microcephaly
* Physical, neurological, hearing and visual examinations for all live births will be performed where possible.
Analysis and reporting (study activity)
o All results will be shared publically through conferences and peer-reviewed publications.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: