Zika Virus Disease (Disorder)NCT02856984
Zika in Infants and Pregnancy (ZIP)
An observational study of Zika Virus Disease (Disorder), run by RTI International at 10 sites in 6 countries.
Trial summary
The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Zika Virus Disease (Disorder)
- How many people
- 6,461 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Jun 2016to 5 May 2020
- 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 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will recruit up to 10,000 pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test from ZIKV-endemic regions and follow them longitudinally to study the impact of incident ZIKV during pregnancy on maternal, fetal, and newborn outcomes. Researchers will identify cases of incident ZIKV among pregnant women by monitoring for symptoms of Zika-like illness and performing serial laboratory sampling for diagnosis of seroconversion and viral shedding. After delivery, infants born with evidence of ZIKV or born to mothers diagnosed with incident virus infection will be followed in a prospective longitudinal cohort for at least 1 year. In addition, a control group of infants born to mothers without evidence of ZIKV during pregnancy will be followed.
Who may be able to join
- Informed consent
- Age >15 years
- Assent and consent as required per local country regulations
- Confirmation of pregnancy by beta human chorionic gonadotropin (hCG) measurement in blood/urine or ultrasound confirmation of pregnancy with fetal heart tones present
- Pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test.
- All infants born to women enrolled in the observational cohort are eligible for enrollment
Who cannot join
- Women who cannot adhere to proposed testing schedule
- Pregnant women enrolled in other research including other ZIKV research
- Mother or custodial parent does not consent to have child participate
- Infants born to mothers that are not part of the ZIP cohort study
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Brazil4 sites
Departamento de Medicina Tropical da Universidade Federal de Pernambuco-UFPE
Recife, Pernambuco, CEP: 50670-901
Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes, 3900 - Monte Alegre
Ribeirão Preto, São Paulo, 14049-900
Instituto Fernandes Figueira - FIOCRUZ
Rio de Janeiro, Rio de Janeiro, 22250-020
Centro de Pesquisas Gonçalo Moniz, Fundação Oswaldo Cruz/MS; Rue Waldemar Falcao
Salvador, Estado de Bahia, 40296-710
Puerto Rico2 sites
University of Puerto Rico Medical Sciences Campus
San Juan, 00921
University of Puerto Rico - Recinto de Río Piedras
San Juan, 00936
Guatemala1 site
Fundación para la Alimentación y Nutrición de Centro América y Panamá (INCAP)
Guatemala City
Nicaragua1 site
MINSA Central
Managua, 16064
About this study
Official title: International Prospective Observational Cohort Study of Zika in Infants
The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The study will prospectively enroll a cohort of pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test. The study will follow these women through their pregnancy to identify for clinical evidence of acute ZIKV, while controlling for potential confounders. Outcomes in the women, the developing fetus, and infants will be assessed. All protocol-specified data will be recorded and entered in a central data management system for the purposes of analysis of composite data from the study.
Read the detailed description
The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The study will prospectively enroll a cohort of pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test. The study will follow these women through their pregnancy to identify for clinical evidence of acute ZIKV, while controlling for potential confounders. Outcomes in the women, the developing fetus, and infants will be assessed. All protocol-specified data will be recorded and entered in a central data management system for the purposes of analysis of composite data from the study.
The study will recruit up to10,000 pregnant women in their first trimester from ZIKV-endemic regions and follow them longitudinally to study the impact of incident ZIKV during pregnancy on maternal, fetal, and newborn outcomes. Researchers will identify cases of incident ZIKV among pregnant women by monitoring for symptoms of Zika-like illness and performing serial laboratory sampling for diagnosis of seroconversion and viral shedding. After delivery, infants born with evidence of ZIKV or born to mothers diagnosed with incident virus infection will be followed in a prospective longitudinal cohort for at least 1 year. In addition, a control group of infants born to mothers without evidence of ZIKV during pregnancy will be followed.
- Conditions
- Zika Virus Disease (Disorder)
- Keywords
- Pregnancy, Infant
- Medical subject headings
- Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ZIKV infected women | The study will prospectively enroll pregnant women up to 17 weeks and 6 days gestation and follow them through their pregnancy for clinical evidence of acute ZIKV infection while controlling for potential confounders. All pregnant women will be followed throughout the pregnancy, delivery, and 6 weeks postpartum. Outcomes in women, the developing fetus, and infants will be assessed. | |
| Control (uninfected women) | The women who remain uninfected will serve as the internal comparison group. The infants who remain uninfected at delivery and throughout the follow-up period will serve as the internal comparison group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of congenital malformations for ZIKV infected participants
To measure the incidence of congenital malformations in fetuses/infants.
Measured: Time of birth of infant
Incidence of congenital malformations for ZIKV infected participants
To measure the incidence of congenital malformations in fetuses/infants.
Measured: 3 months of age
Incidence of congenital malformations for ZIKV infected participants
To measure the incidence of congenital malformations in fetuses/infants.
Measured: 6 months of age
Incidence of congenital malformations for ZIKV infected participants
To measure the incidence of congenital malformations in fetuses/infants.
Measured: 12 months of age
Incidence of adverse fetal outcomes for ZIKV infected participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Measured: Time of birth of infant
Incidence of adverse fetal outcomes for ZIKV infected participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Measured: 3 months of age
Incidence of adverse fetal outcomes for ZIKV infected participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Measured: 6 months of age
Incidence of adverse fetal outcomes for ZIKV infected participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Measured: 12 months of age
Incidence of congenital malformations for ZIKV symptomatic participants
To measure the incidence of congenital malformations in fetuses/infants.
Measured: Time of birth of infant
Incidence of congenital malformations for ZIKV symptomatic participants
To measure the incidence of congenital malformations in fetuses/infants.
Measured: 3 months of age
Incidence of congenital malformations for ZIKV symptomatic participants
To measure the incidence of congenital malformations in fetuses/infants.
Measured: 6 months of age
Incidence of congenital malformations for ZIKV symptomatic participants
To measure the incidence of congenital malformations in fetuses/infants.
Measured: 12 months of age
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Measured: Time of birth of infant
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Measured: 3 months of age
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Measured: 6 months of age
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Measured: 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJun 2016
- Primary completion5 May 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Zika Virus Disease (Disorder)Studies of the same condition, open and under way.
- 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
- 6,461 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Environmental Health Sciences (NIEHS), Oswaldo Cruz Foundation
- Responsible party
- Sponsor
- Investigators
- Ricardo Ximenes, MD, Principal investigator, Departamento de Medicina Tropical da Universidade Federal de Pernambuco-UFPEWilliam Britt, MD, Principal investigator, University of Alabama Birmingham School of MedicineMarisa Mussi, MD, Principal investigator, University of Sao PauloAlbert Ko, MD, Principal investigator, Yale University, Laboratory of Epidemiology and Public HealthDeolinda Scalabrin, Principal investigator, Centro de Pesquisas Gonçalo Moniz, Fundação Oswaldo Cruz/MSMarisa Elisabeth Lopes, Principal investigator, Instituto Fernandes Figueira - FIOCRUZAna Garces, MD, Principal investigator, Fundación para la Alimentación y Nutrición de Centro América y Panamá (INCAP)Jose Cordero, MD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856984
- Sponsor's protocol ID
- GN ZIKA
- Status last verified
- Aug 2021
- First submitted
- 20 Jul 2016
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: de-identified participant data will be entered into the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (N-DASH) system.
Publications
WHO statement on the first meeting of the International Health Regulations (2005) (IHR 2005) Emergency Committee on Zika virus and observed increase in neurological disorders and neonatal malformations; 1 February 2016. Available at http://www.who.int/ mediacentre/news/statements/2016/1st-emergency-committee-zika/en/
Petersen EE, Staples JE, Meaney-Delman D, Fischer M, Ellington SR, Callaghan WM, Jamieson DJ. Interim Guidelines for Pregnant Women During a Zika Virus Outbreak--United States, 2016. MMWR Morb Mortal Wkly Rep. 2016 Jan 22;65(2):30-3. doi: 10.15585/mmwr.mm6502e1.
PubMed 26796813Powles R, Smith C, Milan S, Treleaven J, Millar J, McElwain T, Gordon-Smith E, Milliken S, Tiley C. Human recombinant GM-CSF in allogeneic bone-marrow transplantation for leukaemia: double-blind, placebo-controlled trial. Lancet. 1990 Dec 8;336(8728):1417-20. doi: 10.1016/0140-6736(90)93111-2.
PubMed 1978880CDC. Chikungunya virus. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. http://www.cdc.gov/chikungunya/hc/clinicalevaluation.html
Dengue: Guidelines for Diagnosis, Treatment, Prevention and Control: New Edition. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK143157/
PubMed 23762963CDC Zika Virus; Areas with Zika http://www.cdc.gov/zika/geo/index.html
Oliveira Melo AS, Malinger G, Ximenes R, Szejnfeld PO, Alves Sampaio S, Bispo de Filippis AM. Zika virus intrauterine infection causes fetal brain abnormality and microcephaly: tip of the iceberg? Ultrasound Obstet Gynecol. 2016 Jan;47(1):6-7. doi: 10.1002/uog.15831. No abstract available.
PubMed 26731034CDC. West Nile virus: insect repellent use & safety. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. http://www.cdc.gov/westnile/faq/repellent.html.
CDC. Zika virus. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. http://www.cdc.gov/zika/index.html
Oduyebo T, Petersen EE, Rasmussen SA, Mead PS, Meaney-Delman D, Renquist CM, Ellington SR, Fischer M, Staples JE, Powers AM, Villanueva J, Galang RR, Dieke A, Munoz JL, Honein MA, Jamieson DJ. Update: Interim Guidelines for Health Care Providers Caring for Pregnant Women and Women of Reproductive Age with Possible Zika Virus Exposure - United States, 2016. MMWR Morb Mortal Wkly Rep. 2016 Feb 12;65(5):122-7. doi: 10.15585/mmwr.mm6505e2.
PubMed 26866840Babaliche P, Doshi D. Catching Dengue Early: Clinical Features and Laboratory Markers of Dengue Virus Infection. J Assoc Physicians India. 2015 May;63(5):38-41.
PubMed 26591143Wahala WM, Silva AM. The human antibody response to dengue virus infection. Viruses. 2011 Dec;3(12):2374-95. doi: 10.3390/v3122374. Epub 2011 Nov 25.
PubMed 22355444Gibney KB, Edupuganti S, Panella AJ, Kosoy OI, Delorey MJ, Lanciotti RS, Mulligan MJ, Fischer M, Staples JE. Detection of anti-yellow fever virus immunoglobulin m antibodies at 3-4 years following yellow fever vaccination. Am J Trop Med Hyg. 2012 Dec;87(6):1112-5. doi: 10.4269/ajtmh.2012.12-0182. Epub 2012 Oct 29.
PubMed 23109371Roehrig JT, Nash D, Maldin B, Labowitz A, Martin DA, Lanciotti RS, Campbell GL. Persistence of virus-reactive serum immunoglobulin m antibody in confirmed west nile virus encephalitis cases. Emerg Infect Dis. 2003 Mar;9(3):376-9. doi: 10.3201/eid0903.020531.
PubMed 12643836http://www.salud.gov.pr/Estadisticas-Registros-y-Publicaciones/Informes %20Arbovirales/Reporte%20ArboV%20semana%204-2016.pdf
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Prospective Observational Cohort Study of Zika in Infants
- ClinicalTrials.gov ID
- NCT02856984
- Acronym / sponsor ID
- GN ZIKA
- Conditions
- Zika Virus Disease (Disorder)
- Keywords
- Pregnancy, Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,461 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Environmental Health Sciences (NIEHS), Oswaldo Cruz Foundation
- Study start
- Jun 2016
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 5 Aug 2016 (estimated)
- 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.
The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The study will prospectively enroll a cohort of pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test. The study will follow these women through their pregnancy to identify for clinical evidence of acute ZIKV, while controlling for potential confounders. Outcomes in the women, the developing fetus, and infants will be assessed. All protocol-specified data will be recorded and entered in a central data management system for the purposes of analysis of composite data from the study.
Detailed description
The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The study will prospectively enroll a cohort of pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test. The study will follow these women through their pregnancy to identify for clinical evidence of acute ZIKV, while controlling for potential confounders. Outcomes in the women, the developing fetus, and infants will be assessed. All protocol-specified data will be recorded and entered in a central data management system for the purposes of analysis of composite data from the study.
The study will recruit up to10,000 pregnant women in their first trimester from ZIKV-endemic regions and follow them longitudinally to study the impact of incident ZIKV during pregnancy on maternal, fetal, and newborn outcomes. Researchers will identify cases of incident ZIKV among pregnant women by monitoring for symptoms of Zika-like illness and performing serial laboratory sampling for diagnosis of seroconversion and viral shedding. After delivery, infants born with evidence of ZIKV or born to mothers diagnosed with incident virus infection will be followed in a prospective longitudinal cohort for at least 1 year. In addition, a control group of infants born to mothers without evidence of ZIKV during pregnancy will be followed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZIKV infected women | – | –The study will prospectively enroll pregnant women up to 17 weeks and 6 days gestation and follow them through their pregnancy for clinical evidence of acute ZIKV infection while controlling for potential confounders. All pregnant women will be followed throughout the pregnancy, delivery, and 6 weeks postpartum. Outcomes in women, the developing fetus, and infants will be assessed. |
| Control (uninfected women) | – | –The women who remain uninfected will serve as the internal comparison group. The infants who remain uninfected at delivery and throughout the follow-up period will serve as the internal comparison group. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will recruit up to 10,000 pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test from ZIKV-endemic regions and follow them longitudinally to study the impact of incident ZIKV during pregnancy on maternal, fetal, and newborn outcomes. Researchers will identify cases of incident ZIKV among pregnant women by monitoring for symptoms of Zika-like illness and performing serial laboratory sampling for diagnosis of seroconversion and viral shedding. After delivery, infants born with evidence of ZIKV or born to mothers diagnosed with incident virus infection will be followed in a prospective longitudinal cohort for at least 1 year. In addition, a control group of infants born to mothers without evidence of ZIKV during pregnancy will be followed.
Key inclusion criteria (6 listed)
- Informed consent
- Age >15 years
- Assent and consent as required per local country regulations
- Confirmation of pregnancy by beta human chorionic gonadotropin (hCG) measurement in blood/urine or ultrasound confirmation of pregnancy with fetal heart tones present
- Pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test.
Key exclusion criteria (4 listed)
- Women who cannot adhere to proposed testing schedule
- Pregnant women enrolled in other research including other ZIKV research
- Mother or custodial parent does not consent to have child participate
- Infants born to mothers that are not part of the ZIP cohort study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of congenital malformations for ZIKV infected participants
Time frame: Time of birth of infant
To measure the incidence of congenital malformations in fetuses/infants.
Incidence of congenital malformations for ZIKV infected participants
Time frame: 3 months of age
To measure the incidence of congenital malformations in fetuses/infants.
Incidence of congenital malformations for ZIKV infected participants
Time frame: 6 months of age
To measure the incidence of congenital malformations in fetuses/infants.
Incidence of congenital malformations for ZIKV infected participants
Time frame: 12 months of age
To measure the incidence of congenital malformations in fetuses/infants.
Incidence of adverse fetal outcomes for ZIKV infected participants
Time frame: Time of birth of infant
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Incidence of adverse fetal outcomes for ZIKV infected participants
Time frame: 3 months of age
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Incidence of adverse fetal outcomes for ZIKV infected participants
Time frame: 6 months of age
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Incidence of adverse fetal outcomes for ZIKV infected participants
Time frame: 12 months of age
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Incidence of congenital malformations for ZIKV symptomatic participants
Time frame: Time of birth of infant
To measure the incidence of congenital malformations in fetuses/infants.
Incidence of congenital malformations for ZIKV symptomatic participants
Time frame: 3 months of age
To measure the incidence of congenital malformations in fetuses/infants.
Incidence of congenital malformations for ZIKV symptomatic participants
Time frame: 6 months of age
To measure the incidence of congenital malformations in fetuses/infants.
Incidence of congenital malformations for ZIKV symptomatic participants
Time frame: 12 months of age
To measure the incidence of congenital malformations in fetuses/infants.
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
Time frame: Time of birth of infant
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
Time frame: 3 months of age
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
Time frame: 6 months of age
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Incidence of adverse fetal outcomes for ZIKV symptomatic participants
Time frame: 12 months of age
To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- BackgroundWHO statement on the first meeting of the International Health Regulations (2005) (IHR 2005) Emergency Committee on Zika virus and observed increase in neurological disorders and neonatal malformations; 1 February 2016. Available at http://www.who.int/ mediacentre/news/statements/2016/1st-emergency-committee-zika/en/
- Background: PubMed 26796813Petersen EE, Staples JE, Meaney-Delman D, Fischer M, Ellington SR, Callaghan WM, Jamieson DJ. Interim Guidelines for Pregnant Women During a Zika Virus Outbreak--United States, 2016. MMWR Morb Mortal Wkly Rep. 2016 Jan 22;65(2):30-3. doi: 10.15585/mmwr.mm6502e1.
- Background: PubMed 1978880Powles R, Smith C, Milan S, Treleaven J, Millar J, McElwain T, Gordon-Smith E, Milliken S, Tiley C. Human recombinant GM-CSF in allogeneic bone-marrow transplantation for leukaemia: double-blind, placebo-controlled trial. Lancet. 1990 Dec 8;336(8728):1417-20. doi: 10.1016/0140-6736(90)93111-2.
- BackgroundCDC. Chikungunya virus. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. http://www.cdc.gov/chikungunya/hc/clinicalevaluation.html
- Background: PubMed 23762963Dengue: Guidelines for Diagnosis, Treatment, Prevention and Control: New Edition. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK143157/
- BackgroundCDC Zika Virus; Areas with Zika http://www.cdc.gov/zika/geo/index.html
- Background: PubMed 26731034Oliveira Melo AS, Malinger G, Ximenes R, Szejnfeld PO, Alves Sampaio S, Bispo de Filippis AM. Zika virus intrauterine infection causes fetal brain abnormality and microcephaly: tip of the iceberg? Ultrasound Obstet Gynecol. 2016 Jan;47(1):6-7. doi: 10.1002/uog.15831. No abstract available.
- BackgroundCDC. West Nile virus: insect repellent use & safety. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. http://www.cdc.gov/westnile/faq/repellent.html.
- BackgroundCDC. Zika virus. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. http://www.cdc.gov/zika/index.html
- Background: PubMed 26866840Oduyebo T, Petersen EE, Rasmussen SA, Mead PS, Meaney-Delman D, Renquist CM, Ellington SR, Fischer M, Staples JE, Powers AM, Villanueva J, Galang RR, Dieke A, Munoz JL, Honein MA, Jamieson DJ. Update: Interim Guidelines for Health Care Providers Caring for Pregnant Women and Women of Reproductive Age with Possible Zika Virus Exposure - United States, 2016. MMWR Morb Mortal Wkly Rep. 2016 Feb 12;65(5):122-7. doi: 10.15585/mmwr.mm6505e2.
- Background: PubMed 26591143Babaliche P, Doshi D. Catching Dengue Early: Clinical Features and Laboratory Markers of Dengue Virus Infection. J Assoc Physicians India. 2015 May;63(5):38-41.
- Background: PubMed 22355444Wahala WM, Silva AM. The human antibody response to dengue virus infection. Viruses. 2011 Dec;3(12):2374-95. doi: 10.3390/v3122374. Epub 2011 Nov 25.
- Individual participant dataSharing planned: Yes. de-identified participant data will be entered into the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (N-DASH) system.
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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.
Ricardo Ximenes, MD principal investigator
Departamento de Medicina Tropical da Universidade Federal de Pernambuco-UFPE
William Britt, MD principal investigator
University of Alabama Birmingham School of Medicine
Marisa Mussi, MD principal investigator
University of Sao Paulo
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Zika Virus Disease (Disorder), run by RTI International at 10 sites in 6 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Brazil, Puerto Rico, Colombia, Guatemala, Nicaragua and 1 more country. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 congenital malformations for ZIKV infected participants (time frame: Time of birth of infant). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02856984, which also lists 28 linked publications.
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 19 Aug 2021.