MicrocephalyNCT03922594
Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia
An observational study of Microcephaly and Congenital Infection, run by Institut Pasteur at 8 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 0 to 2 days
- Conditions the study is for
- Microcephaly, Congenital Infection
- What is being tested?
- Differential diagnosis for infectious causes of microcephaly
- How many people
- 150 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 20 May 2019to 31 Aug 2021
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 2 days
- All sexes
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Infants/fetuses with microcephaly whose mothers are under the age of 18 years,
- or inability or refusal of mothers/ guardians to give informed consent.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Cameroon2 sites
Central Hospital Maternity
Yaoundé
Essos Hospital Centre Maternity
Yaoundé
Côte d’Ivoire2 sites
General Hospital Abobo-Sud
Abidjan
General Hospital of Yopougon-Attie
Abidjan
Sri Lanka2 sites
Castle Street Hospital for Women
Colombo
De Soyza Hospital for Women
Colombo
About this study
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.
Read the 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)
- All results will be shared publically through conferences and peer-reviewed publications.
- Conditions
- Microcephaly, Congenital Infection
- Being tested
- Differential diagnosis for infectious causes of microcephaly
- Medical subject headings
- Microcephaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differential diagnosis for infectious causes of microcephalyDiagnostic test
Zika virus, cytomegalovirus, rubella, toxoplasmosis
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Differential diagnosis for infectious causes of microcephaly | |
| 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 Receives: Diagnostic Test: Differential diagnosis for infectious causes of microcephaly | |
| 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 Receives: Diagnostic Test: Differential diagnosis for infectious causes of microcephaly | |
| 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 Receives: Diagnostic Test: Differential diagnosis for infectious causes of microcephaly | |
| 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 Receives: Diagnostic Test: Differential diagnosis for infectious causes of microcephaly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of microcephaly (per 10,000 live births)
Incidence of microcephaly (per 10,000 live births)
Measured: At birth
Proportion of microcephaly attributable to ZIKV
Proportion of microcephaly attributable to Zika virus infection
Measured: At birth
Proportion of microcephaly linked to other infectious etiologies
Proportion of microcephaly linked to other infectious etiologies (non-ZIKV)
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start20 May 2019
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Why it stopped: 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrocephalyStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Pasteur du Cameroun, Guangzhou Women and Children's Medical Center, Institut Pasteur of Cote d'Ivoire, Pasteur Institute, 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, 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
- Responsible party
- Sponsor
- Investigators
- Arnaud Fontanet, Principal investigator, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922594
- Sponsor's protocol ID
- ZIKA_2016-102
- Status last verified
- Mar 2022
- First submitted
- 17 Apr 2019
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia
- ClinicalTrials.gov ID
- NCT03922594
- Acronym / sponsor ID
- ZIKA_2016-102
- Conditions
- Microcephaly, Congenital Infection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 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
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Centre Pasteur du Cameroun, Guangzhou Women and Children's Medical Center, Institut Pasteur of Cote d'Ivoire, Pasteur Institute, 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, 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
- Study start
- 20 May 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- All results will be shared publically through conferences and peer-reviewed publications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cameroon | – | Diagnostic Test: Differential diagnosis for infectious causes of microcephalyLive 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 |
| China | – | Diagnostic Test: Differential diagnosis for infectious causes of microcephalyFetuses 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 |
| Ivory Coast | – | Diagnostic Test: Differential diagnosis for infectious causes of microcephalyLive 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 |
| Sri Lanka | – | Diagnostic Test: Differential diagnosis for infectious causes of microcephalyLive 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 |
| Vietnam | – | Diagnostic Test: Differential diagnosis for infectious causes of microcephalyFetuses 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 |
Who may qualify
- Ages
- 0 to 2 days
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Infants/fetuses with microcephaly whose mothers are under the age of 18 years,
- or inability or refusal of mothers/ guardians to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Differential diagnosis for infectious causes of microcephalyZika virus, cytomegalovirus, rubella, toxoplasmosis | Diagnostic test | Cameroon, China, Ivory Coast, Sri Lanka, Vietnam |
Primary outcome
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)
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Fontanet principal investigator
Institut Pasteur
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microcephaly and Congenital Infection, run by Institut Pasteur at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Cameroon, Côte d’Ivoire, Sri Lanka, China, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of microcephaly (per 10,000 live births) (time frame: At birth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.