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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03922594

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted June 25, 2019

Study Description

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.

  • Condition or Disease:Microcephaly
    Congenital Infection
  • Intervention/Treatment: Diagnostic Test: Differential diagnosis for infectious causes of microcephaly
  • Phase: N/A
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.

Study Design
  • Study Type: Observational [Patient Registry]
  • Estimated Enrollment: 125 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: June 2021
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Cameroon
Live newborns with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns
Diagnostic Test: Differential diagnosis for infectious causes of microcephaly
Zika virus, cytomegalovirus, rubella, toxoplasmosis
: China
Fetuses or newborns (still-born, medical abortions or alive) with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns
Diagnostic Test: Differential diagnosis for infectious causes of microcephaly
Zika virus, cytomegalovirus, rubella, toxoplasmosis
: Ivory Coast
Live newborns with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex and severely disproportionate length or weight according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns
Diagnostic Test: Differential diagnosis for infectious causes of microcephaly
Zika virus, cytomegalovirus, rubella, toxoplasmosis
: Sri Lanka
Live newborns with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns
Diagnostic Test: Differential diagnosis for infectious causes of microcephaly
Zika virus, cytomegalovirus, rubella, toxoplasmosis
: Vietnam
Fetuses or newborns (still-born, medical abortions or alive) with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns
Diagnostic Test: Differential diagnosis for infectious causes of microcephaly
Zika virus, cytomegalovirus, rubella, toxoplasmosis
Outcome Measures
  • Primary Outcome Measures: 1. Proportion of microcephaly linked to other infectious etiologies [ Time Frame: At birth ]
    Proportion of microcephaly linked to other infectious etiologies (non-ZIKV)
  • 2. Incidence of microcephaly (per 10,000 live births) [ Time Frame: At birth ]
    Incidence of microcephaly (per 10,000 live births)
  • 3. Proportion of microcephaly attributable to ZIKV [ Time Frame: At birth ]
    Proportion of microcephaly attributable to Zika virus infection
Eligibility Criteria
  • Ages Eligible for Study: up to 2 / (Birth to 17 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • Sampling Method: Non-Probability Sample
  • Study Population: Fetuses or newborns (still-born, medical abortions [China and Vietnam only] or alive) with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns.
Criteria

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.

Contacts and Locations
Contacts

Contact: Arnaud Fontanet +331 45 68 80 00 arnaud.fontanet@pasteur.fr

Contact: Rebecca Grant +331 45 68 80 00 rebecca.grant@pasteur.fr

Locations

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 and Collaborators

Institut Pasteur

Centre Pasteur du Cameroun

Guangzhou Women and Children's Medical Center

Institut Pasteur de Côte d'Ivoire

Institut Pasteur Ho Chi Minh City

Tu Du Hospital

Perinatal Society of Sri Lanka

University of Colombo

University of Lausanne

University of Lausanne Hospitals

The University of Hong Kong

Ministry of Health of Sri Lanka

Central Hospital Maternity

Essos Hospital Center

Guangzhou Baiyun Maternal and Child Health Hospital

General Hospital of Yopougon-Attie

General Hospital Abobo-Sud

Castle Street Hospital for Women

De Soyza Hospital for Women

Investigators

Principal Investigator: Arnaud Fontanet Institut Pasteur

More Information
  • Responsible Party: Institut Pasteur
  • ClinicalTrials.gov Identifier: NCT03922594 History of Changes
  • Other Study ID Numbers: ZIKA_2016-102
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: June 25, 2019
  • Last Verified: June 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Microcephaly