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出境医 / 临床实验 / Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia
Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia
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 | 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.
Study Design
| 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 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- Incidence of microcephaly (per 10,000 live births) [ Time Frame: At birth ]Incidence of microcephaly (per 10,000 live births)
- Proportion of microcephaly attributable to ZIKV [ Time Frame: At birth ]Proportion of microcephaly attributable to Zika virus infection
- Proportion of microcephaly linked to other infectious etiologies [ Time Frame: At birth ]Proportion of microcephaly linked to other infectious etiologies (non-ZIKV)
Eligibility Criteria
| 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.
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 | 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
| Principal Investigator: | Arnaud Fontanet | Institut Pasteur |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 17, 2019 | ||||
| First Posted Date | April 22, 2019 | ||||
| Last Update Posted Date | June 25, 2019 | ||||
| Actual Study Start Date | May 20, 2019 | ||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia | ||||
| Official Title | Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia | ||||
| 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)
Data collection (study activity)
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] | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 2 Days | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
|
||||
| Intervention | Diagnostic Test: Differential diagnosis for infectious causes of microcephaly
Zika virus, cytomegalovirus, rubella, toxoplasmosis
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
125 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | June 2021 | ||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | up to 2 Days (Child) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Côte D'Ivoire, Cameroon, China, Sri Lanka, Vietnam | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03922594 | ||||
| Other Study ID Numbers | ZIKA_2016-102 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Institut Pasteur | ||||
| Study Sponsor | Institut Pasteur | ||||
| Collaborators |
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| Investigators |
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| PRS Account | Institut Pasteur | ||||
| Verification Date | June 2019 | ||||
