Rapid Diagnostic Tests (RDTs) for Malaria in Kampala, Uganda
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Malaria remains a disease that causes much death and sickness, especially in sub-Saharan Africa. An accurate, simple, and inexpensive method of diagnosing malaria is urgently needed. The purpose of this study is to evaluate a different diagnostic method compared to those most frequently used. The study may also identify the factors causing false positive and false negative results using the alternative method. Participants will be 600 Ugandan children aged 1-10 years who are enrolled in protocol 04-068. Those who develop a fever over the 12 month duration of the study will be tested for malaria by both the standard and the new methods. These tests will require a few drops of blood to be collected by finger prick. Subjects will be treated on the basis of standard diagnostic testing (i.e. expert microscopy).
Condition | Intervention |
---|---|
Febrile Illness Malaria |
Other: -none- |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Official Title: | Utility of Rapid Diagnostic Tests (RDTs) for Malaria in Kampala, Uganda |
- RDT accuracy [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Dried blood spots on filter paper
Enrollment: | 600 |
Study Start Date: | October 2005 |
Study Completion Date: | May 2006 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
study population
601 children enrolled in an on-going longitudinal antimalarial treatment efficacy trial in Kampala, Uganda.
|
Other: -none-
Other Name: No intervention - this is an observational study
|
Detailed Description:
Malaria remains one of the most devastating infectious diseases, causing high morbidity and mortality especially in sub-Saharan Africa. The need for an accurate, simple, and inexpensive method to diagnose malaria has become increasingly urgent. Rapid diagnostic tests (RDTs), based on detection of Plasmodium antigens, may represent a more practical diagnostic tool than traditional light microscopy. This longitudinal study's objectives are (1) to evaluate the clinical performance (sensitivity, specificity, positive and negative predictive values) of RDTs, as compared with presumptive diagnosis and microscopy, for the diagnosis of malaria in children in Kampala, Uganda, and (2) to identify host and test factors that lead to false positive and false negative RDT results by comparison with polymerase chain reaction (PCR) analysis. Study subjects in this RDT study will have already been enrolled in a larger on-going longitudinal study of antimalarial drug efficacy, tolerability, and safety that began at the Kampala study site in late 2004. In the RDT study, over a one-year period, study participants' blood samples will be evaluated with the current gold standard for malaria diagnosis (microscopy) as well as two types of RDT whenever they present with a new fever episode (the first fever after study enrollment, or a fever that occurs more than 14 days after the patient's most recently diagnosed episode of malaria). As part of the on-going longitudinal drug efficacy trial, probability sampling was used to select a random sample of 600 children, who will be followed for three years for all their health-care needs. The RDT study will involve evaluation of the cohort over 12 months, beginning in approximately the third quarter of 2005. This protocol is a substudy of 04-068.
Ages Eligible for Study: | 1 Year to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
601 children enrolled in a longitudinal antimalarial treatment efficacy trial in Kampala, Uganda.
Inclusion Criteria: Member of the cohort participating in clinical trial of antimalarial drug efficacy in Kampala, which was enrolled based on criteria including the following characteristics:
- Ages 1-10 (at time of original enrollment)
- Parents' or guardians' agreement to bring the child to the study clinic for any fevers or other illnesses
- Agreement to avoid medications administered outside the study
- Intention to remain in Kampala for the full study period
- Native Ugandan
Exclusion Criteria:
- Presence of any known serious chronic disease (e.g. AIDS, sickle cell disease, malignancy)
- Serious side effects to study medications used in cohort clinical trial of antimalarial drug efficacy
Additional Information:
Publications:
Responsible Party: | Heidi Hopkins, MD, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00327964 History of Changes |
Other Study ID Numbers: | NIH/DMID 05-0110 |
Study First Received: | May 18, 2006 |
Last Updated: | October 1, 2008 |
Health Authority: | United States: Institutional Review Board Uganda: Research Ethics Committee |
Keywords provided by University of California, San Francisco:
malaria fever Uganda children |
rapid diagnostic tests RDTs Africa |
Additional relevant MeSH terms:
Malaria Protozoan Infections Parasitic Diseases |
ClinicalTrials.gov processed this record on October 16, 2012