Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138489
Status:
TERMINATED
Last Update Posted:
2019-02-04
First Post:
2005-08-26
Brief Title:
Papua New Guinean Duffy Negativity And Vivax Malar
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Protocol 3B Susceptibility to Plasmodium Vivax Infection and Malaria During Early Childhood
Status:
TERMINATED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 childs 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 PCRLigase 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol 3B | None | None | None |