Malaria Clinical Trial
Official title:
Utility of Rapid Diagnostic Tests (RDTs) for Malaria in Kampala, Uganda
NCT number | NCT00327964 |
Other study ID # | NIH/DMID 05-0110 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2005 |
Est. completion date | May 2006 |
Verified date | February 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 600 |
Est. completion date | May 2006 |
Est. primary completion date | May 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 11 Years |
Eligibility |
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: 1. Ages 1-10 (at time of original enrollment) 2. Parents' or guardians' agreement to bring the child to the study clinic for any fevers or other illnesses 3. Agreement to avoid medications administered outside the study 4. Intention to remain in Kampala for the full study period 5. Native Ugandan Exclusion Criteria: 1. Presence of any known serious chronic disease (e.g. AIDS, sickle cell disease, malignancy) 2. Serious side effects to study medications used in cohort clinical trial of antimalarial drug efficacy |
Country | Name | City | State |
---|---|---|---|
Uganda | Mulago Hospital | Kampala |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Institute of Allergy and Infectious Diseases (NIAID) |
Uganda,
Hopkins H, Kambale W, Kamya MR, Staedke SG, Dorsey G, Rosenthal PJ. Comparison of HRP2- and pLDH-based rapid diagnostic tests for malaria with longitudinal follow-up in Kampala, Uganda. Am J Trop Med Hyg. 2007 Jun;76(6):1092-7. — View Citation
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