Malaria Surveillance in Rakai, Uganda

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01265407
First received: December 22, 2010
Last updated: June 11, 2014
Last verified: May 2014
  Purpose

Background:

- Malaria is a leading cause of morbidity and mortality in Uganda, accounting for more than a quarter of all outpatient visits at health facilities, 20 percent of hospital admissions, and about 10 percent of inpatient deaths. Children under 10 years of age, pregnant women, and HIV-infected individuals bear the greatest burden of disease. To provide baseline information for future malaria vaccine research, development, and testing, researchers are interested in collecting malaria infection data from the Rakai district in southern Uganda.

Objectives:

- To assess the epidemiology of malaria infection among children aged 6 months to less than 10 years and adults living in same households with children in Rakai district, Uganda.

Eligibility:

- Children between 6 months and 10 years of age, as well as their primary caregiver and an additional randomly selected adolescent or adult resident of the household, from the Rakai district of Uganda.

Design:

  • Participants will have monthly household visits for a 1-year surveillance period.
  • Each visit will include a structured interview/questionnaire of the primary caregiver or legal guardian of the child and clinical and laboratory assessments of each child, the primary caregiver, and the additional adolescent or adult resident of the household. The questionnaire will ask about malaria treatment and prevention measures.
  • Children will provide a blood sample for testing. Individuals (children or adults) who are diagnosed with malaria or anemia during the course of the study will be recommended for treatment.
  • Researchers will also track usage of the district health clinic and hospital services to link medical records for study participants.

Condition
Malaria

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Malaria Surveillance in Rakai, Uganda

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Episodes of uncomplicated and severe clinical malaria per year in children and adults. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Malaria rates (episodes/per year) in individuals and communities and by seasonality. Clinical episodes will be determined using RDT among febrile participants. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Determine the rates of asymptomatic parasitemia among afebrileparticipants (determined by malaria smears and PCR). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The prevalence of enlarged palpable spleen (splenomegaly) in children [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1700
Study Start Date: December 2010
Detailed Description:

Malaria is a leading cause of morbidity and mortality in Uganda, accounting for 25-40 percent of all outpatient visits at health facilities, 20 percent of hospital admissions, and 9-14 percent of inpatient deaths. Malaria is meso- to holoendemic in Rakai, southwestern Uganda and children under 10 years, pregnant women and HIVinfected individuals bear the greatest burden of disease. Substantial progress has been made in malaria vaccine development and vaccine trials will be conducted over the coming years. The design of these trials will be contingent on understanding the epidemiology of malaria and disease burden in different epidemic settings.

This study will determine the epidemiology of malaria infection in children and adolescents/adults by conducting surveillance in 320 households selected from two of the 10 clusters under the Rakai Community Cohort Study (RCCS). Monthly visits will be made to randomly selected households during a one year surveillance period. Visit procedures include: structured interview/questionnaire of the primary care giver or legal guardian of the child; clinical and laboratory assessment of each child aged 6 months up to 10 years and the primary care giver; and clinical and laboratory assessment of one additional randomly selected adolescent/adult resident of the household. The study team will track usage of health clinic or hospital services within the district in order to link medical records for study participants. This community-based surveillance study will be linked to a separate facility-based surveillance study in health clinics/hospitals servicing the selected communities. This study will enhance the investigators understanding of the epidemiology of pediatric and adult malaria infection in Rakai district in preparation for future malaria vaccine trials. Investigators will be able to estimate the incidence of uncomplicated and severe malaria in children and adults. This protocol will also investigate the prevalence and association of sickle cell trait, xlinked glucose-6-phosphatase dehydrogenase deficiency and hemoglobinopathies (Hemoglobin C) and their associations with severe malaria among children and adults.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Child aged 6 months to less than 10 years, primary care giver of an enrolled child, or an adolescent/adult resident in a household of an enrolled child.
    2. Willingness to participate in the study as evidenced by a completed and signed parental informed consent document and consent for child research participation (with assent of child/adolescent if appropriate).

EXCLUSION CRITERIA:

  1. Clinical evidence of an acute, life-threatening illness requiring immediate medical care at time of baseline household visit, not including severe malaria.
  2. Intent to stay in a study household for less than 12 months from the start of the study.
  3. School-going child in a boarding school who spends most of their time in a year at school rather than at home.
  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: NCT01265407

Locations
Uganda
Rakai Health Sciences Program
Rakai, Uganda
Sponsors and Collaborators
Investigators
Principal Investigator: Steven J Reynolds, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01265407     History of Changes
Other Study ID Numbers: 999911050, 11-I-N050
Study First Received: December 22, 2010
Last Updated: June 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Children
Hemoglobinopathies
Epidemiology
Malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on September 18, 2014