Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia

Microcephaly Clinical Trial

Official title:

Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03922594
• Other study ID #: ZIKA_2016-102
• Status: Terminated
• Start date: May 20, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2022
• Source: Institut Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Gender: All
• Age group: N/A to 2 Days

Eligibility

Inclusion Criteria:

• All infants or fetuses with microcephaly, (defined as head circumference =-3SD according to INTERGROWTH standards for gestational age and sex, detected during the mother's pregnancy, or at the end of the mother's pregnancy at one of the participating maternities)

• and with abnormal ultrasound and/or clinical examination findings for newborns.

Exclusion Criteria:

• Infants/fetuses with microcephaly whose mothers are under the age of 18 years,

• or inability or refusal of mothers/ guardians to give informed consent.

Related Conditions & MeSH terms

• Congenital Infection
• Microcephaly

Intervention

Diagnostic Test:
• Differential diagnosis for infectious causes of microcephaly
Zika virus, cytomegalovirus, rubella, toxoplasmosis

Locations

Country	Name	City	State
Cameroon	Central Hospital Maternity	Yaoundé
Cameroon	Essos Hospital Centre Maternity	Yaoundé
China	Guangzhou Women's and Children's Hospital	Guangzhou
Côte D'Ivoire	General Hospital Abobo-Sud	Abidjan
Côte D'Ivoire	General Hospital of Yopougon-Attie	Abidjan
Sri Lanka	Castle Street Hospital for Women	Colombo
Sri Lanka	De Soyza Hospital for Women	Colombo
Vietnam	Tu Du Hospital	Ho Chi Minh City

Sponsors (19)

Lead Sponsor

Collaborator

Institut Pasteur

Castle Street Hospital for Women, Central Hospital Maternity, Centre Pasteur du Cameroun, De Soyza Hospital for Women, Essos Hospital Center, General Hospital Abobo-Sud, General Hospital of Yopougon-Attie, Guangzhou Baiyun Maternal and Child Health Hospital, Guangzhou Women and Children's Medical Center, Institut Pasteur of Cote d'Ivoire, Ministry of Health of Sri Lanka, Pasteur Institute, Ho Chi Minh City, Perinatal Society of Sri Lanka, The University of Hong Kong, Tu Du Hospital, University of Colombo, University of Lausanne, University of Lausanne Hospitals

Countries where clinical trial is conducted

Cameroon,  China,  Côte D'Ivoire,  Sri Lanka,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of microcephaly (per 10,000 live births)	Incidence of microcephaly (per 10,000 live births)	At birth
Primary	Proportion of microcephaly attributable to ZIKV	Proportion of microcephaly attributable to Zika virus infection	At birth
Primary	Proportion of microcephaly linked to other infectious etiologies	Proportion of microcephaly linked to other infectious etiologies (non-ZIKV)	At birth