Plasmodium Vivax MalariaNCT00138489
Papua New Guinean Duffy Negativity And Vivax Malar
An observational study of Plasmodium Vivax Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Papua New Guinea.
Trial summary
The purpose of this study is to learn more about vivax malaria in very young children, how the growth of children is affected by malaria infections, and how inherited traits protect children from getting malaria. Read more about this study
- Who is it for?
- Ages Up to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Vivax Malaria
- How many people
- 266 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- 10 Feb 2004to not given
- 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 Up to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The following criteria are applicable to this study. All three of the inclusion criteria must be met.
- < = 12 months of age at the time of eligibility assessment Residence in a designated study village Parental / legal guardian consent
- Participants who move outside the study area during the course of the study will be dropped from further participation. However, data collected to that point may be included in statistical analyses. Parental consent to study is essential. No blood samples or measurements will be taken on a child without informed consent.
Who cannot join
- The following exclusion criteria are applicable to this study. Any one or more of the criteria is sufficient to exclude study participation.
- > 12 months of age at the time of eligibility assessment Chronic illness, severe malnutrition, permanent disability, or a congenital malformation that prevents or impedes study participation Short-term, temporary residence (less than 6 months) in a designated study village Residence in a village outside of the study area Parental refusal to consent to study
Trial locations and contacts
1 site in 1 country.
Papua New Guinea1 site
Papua New Guinea Institute of Medical Research
Goroka, EHP 441
About this study
Official title: Protocol 3B Susceptibility to Plasmodium Vivax Infection and Malaria During Early Childhood
The purpose of this study is to learn more about vivax malaria in very young children, how the growth of children is affected by malaria infections, and how inherited traits protect children from getting malaria. Participants will be 266 children 24 months of age or younger who live in certain villages in East Sepik Province, Papua New Guinea, where malaria is very common. The study also will find out how malaria spreads in the area. By learning how and when a child develops resistance to vivax malaria, researchers can try to find ways to help people from getting it. And, they can get a better understanding of how inherited traits influence all types of malaria infections. In this study, the parent and child will be visited by the study team or health workers every week to check health and bednet use. Every 2 weeks, the study team will take a small blood sample to check for malaria and take measurements to study the child's growth. Participants will be followed for up to 2 years.
Read the detailed description
This study specifically seeks to document infection by Plasmodium species parasites in a prospective longitudinal study using blood smear and polymerase chain reaction (PCR)/Ligase Detection Reaction (LDR) diagnostic techniques and to determine when a child becomes susceptible to blood-stage malaria in a cohort of non-immune children from villages where a genetic polymorphism that blocks expression of Duffy (Fy) blood group antigen has been identified. The goal of this project is to prospectively study the natural history of Plasmodium vivax malaria in a malaria-endemic region of Papua New Guinea among a cohort of children 24 months of age and older for a period of up to two years. The primary objectives of this study are to: 1) determine the mean time to first P. vivax infection, and 2) determine the incidence rate of P. vivax infection. The secondary objectives of this study are to: 1) assess the impact of recurrent Plasmodium infections on child growth, 2) estimate the sensitivity and specificity of blood smear versus PCR-based diagnostic methods for P. vivax infection, and 3) evaluate the effect of the FY genotype on P. vivax malaria. Cross-sectional malaria prevalence data based on blood smear diagnosis suggest that the risk of malaria is extremely low during infancy in this population. Therefore, at the start of the study, children 12 months of age and younger will be eligible for the study, and all new births occurring over the next 15 months will be added to the cohort ensuring that the last newborn will have a minimum of 9 months of follow-up. All children enrolled in this study will be followed weekly to detect clinical malaria and biweekly blood samples will be taken for the detection of asymptomatic malaria. Follow-up will continue for a period of up to 2 years until participants reach 24 months of age, or withdraw from the study or until the study ends, whichever event comes first.
- Conditions
- Plasmodium Vivax Malaria
- Keywords
- Malaria, Papua New Guinea, infants, children
- Medical subject headings
- Malaria, Vivax, Malaria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study start10 Feb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Vivax MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Time perspective
- Prospective
- Enrolment
- 266 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138489
- Sponsor's protocol ID
- 02-004
- Other IDs
- Protocol 3B
- Status last verified
- Oct 2007
- First submitted
- 26 Aug 2005
- Last updated
- 4 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol 3B Susceptibility to Plasmodium Vivax Infection and Malaria During Early Childhood
- ClinicalTrials.gov ID
- NCT00138489
- Acronym / sponsor ID
- 02-004
- Conditions
- Plasmodium Vivax Malaria
- Keywords
- Malaria, Papua New Guinea, infants, children
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 266 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 10 Feb 2004
- First posted
- 30 Aug 2005 (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 purpose of this study is to learn more about vivax malaria in very young children, how the growth of children is affected by malaria infections, and how inherited traits protect children from getting malaria. Participants will be 266 children 24 months of age or younger who live in certain villages in East Sepik Province, Papua New Guinea, where malaria is very common. The study also will find out how malaria spreads in the area. By learning how and when a child develops resistance to vivax malaria, researchers can try to find ways to help people from getting it. And, they can get a better understanding of how inherited traits influence all types of malaria infections. In this study, the parent and child will be visited by the study team or health workers every week to check health and bednet use. Every 2 weeks, the study team will take a small blood sample to check for malaria and take measurements to study the child's growth. Participants will be followed for up to 2 years.
Detailed description
This study specifically seeks to document infection by Plasmodium species parasites in a prospective longitudinal study using blood smear and polymerase chain reaction (PCR)/Ligase Detection Reaction (LDR) diagnostic techniques and to determine when a child becomes susceptible to blood-stage malaria in a cohort of non-immune children from villages where a genetic polymorphism that blocks expression of Duffy (Fy) blood group antigen has been identified. The goal of this project is to prospectively study the natural history of Plasmodium vivax malaria in a malaria-endemic region of Papua New Guinea among a cohort of children 24 months of age and older for a period of up to two years. The primary objectives of this study are to: 1) determine the mean time to first P. vivax infection, and 2) determine the incidence rate of P. vivax infection. The secondary objectives of this study are to: 1) assess the impact of recurrent Plasmodium infections on child growth, 2) estimate the sensitivity and specificity of blood smear versus PCR-based diagnostic methods for P. vivax infection, and 3) evaluate the effect of the FY genotype on P. vivax malaria. Cross-sectional malaria prevalence data based on blood smear diagnosis suggest that the risk of malaria is extremely low during infancy in this population. Therefore, at the start of the study, children 12 months of age and younger will be eligible for the study, and all new births occurring over the next 15 months will be added to the cohort ensuring that the last newborn will have a minimum of 9 months of follow-up. All children enrolled in this study will be followed weekly to detect clinical malaria and biweekly blood samples will be taken for the detection of asymptomatic malaria. Follow-up will continue for a period of up to 2 years until participants reach 24 months of age, or withdraw from the study or until the study ends, whichever event comes first.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The following criteria are applicable to this study. All three of the inclusion criteria must be met.
- < = 12 months of age at the time of eligibility assessment Residence in a designated study village Parental / legal guardian consent
- Participants who move outside the study area during the course of the study will be dropped from further participation. However, data collected to that point may be included in statistical analyses. Parental consent to study is essential. No blood samples or measurements will be taken on a child without informed consent.
Key exclusion criteria (2 listed)
- The following exclusion criteria are applicable to this study. Any one or more of the criteria is sufficient to exclude study participation.
- > 12 months of age at the time of eligibility assessment Chronic illness, severe malnutrition, permanent disability, or a congenital malformation that prevents or impedes study participation Short-term, temporary residence (less than 6 months) in a designated study village Residence in a village outside of the study area Parental refusal to consent to 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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasmodium Vivax Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Papua New Guinea.
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 3 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Papua New Guinea. 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. 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.
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 4 Feb 2019.