Papua New Guinean Duffy Negativity And Vivax Malar

This study has suspended participant recruitment.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00138489
First received: August 26, 2005
Last updated: August 26, 2010
Last verified: October 2007
  Purpose

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.


Condition
Plasmodium Vivax Malaria

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Protocol 3B Susceptibility to Plasmodium Vivax Infection and Malaria During Early Childhood

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 266
Study Start Date: January 2004
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.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138489

Locations
Papua New Guinea
Papua New Guinea Institute of Medical Research
Goroka, Papua New Guinea, EHP 441
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00138489     History of Changes
Other Study ID Numbers: 02-004, Protocol 3B
Study First Received: August 26, 2005
Last Updated: August 26, 2010
Health Authority: Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Malaria, Papua New Guinea, infants, children

Additional relevant MeSH terms:
Malaria
Malaria, Vivax
Parasitic Diseases
Protozoan Infections

ClinicalTrials.gov processed this record on October 23, 2014