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

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ClinicalTrials.gov Identifier: NCT03922594
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Institut Pasteur

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 Intervention/treatment
Microcephaly Congenital Infection Diagnostic Test: Differential diagnosis for infectious 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021


Group/Cohort 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




Primary Outcome Measures :
  1. Incidence of microcephaly (per 10,000 live births) [ Time Frame: At birth ]
    Incidence of microcephaly (per 10,000 live births)

  2. Proportion of microcephaly attributable to ZIKV [ Time Frame: At birth ]
    Proportion of microcephaly attributable to Zika virus infection

  3. Proportion of microcephaly linked to other infectious etiologies [ Time Frame: At birth ]
    Proportion of microcephaly linked to other infectious etiologies (non-ZIKV)



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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922594


Contacts
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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
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Cameroon
Central Hospital Maternity Recruiting
Yaoundé, Cameroon
Contact: Florent Fouelifack Ymele         
Sub-Investigator: Florent Fouelifack Ymele         
Essos Hospital Centre Maternity Recruiting
Yaoundé, Cameroon
Contact: Anne Njom         
Sub-Investigator: Anne Njom         
China
Guangzhou Women's and Children's Hospital Recruiting
Guangzhou, China
Contact: Xiu (Sue) Qiu         
Principal Investigator: Xiu (Sue) Qiu         
Côte D'Ivoire
General Hospital Abobo-Sud Recruiting
Abidjan, Côte D'Ivoire
Contact: Man-Koumba Soumahoro         
Principal Investigator: Man-Koumba Soumahoro         
General Hospital of Yopougon-Attie Recruiting
Abidjan, Côte D'Ivoire
Contact: Man-Koumba Soumahoro         
Principal Investigator: Man-Koumba Soumahoro         
Sri Lanka
Castle Street Hospital for Women Recruiting
Colombo, Sri Lanka
Contact: Kapila Jayaratne         
Principal Investigator: Kapila Jayaratne         
De Soyza Hospital for Women Recruiting
Colombo, Sri Lanka
Contact: Kapila Jayaratne         
Principal Investigator: Kapila Jayaratne         
Vietnam
Tu Du Hospital Not yet recruiting
Ho Chi Minh City, Vietnam
Contact: Thanh Binh         
Sub-Investigator: Than Binh         
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
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Principal Investigator: Arnaud Fontanet Institut Pasteur

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Microcephaly
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Malformations of Cortical Development, Group I
Malformations of Cortical Development
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities