Clinical Trials Logo

Clinical Trial Summary

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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00327964
Study type Observational
Source University of California, San Francisco
Contact
Status Completed
Phase
Start date October 2005
Completion date May 2006

See also
  Status Clinical Trial Phase
Completed NCT04601714 - Baseline Cohort Malaria Morbidity Study
Withdrawn NCT04020653 - A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria Phase 2
Terminated NCT04368910 - Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria Phase 3
Completed NCT03641339 - Defining Skin Immunity of a Bite of Key Insect Vectors in Humans N/A
Completed NCT02544048 - Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
Completed NCT00527163 - Role of Nitric Oxide in Malaria
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Active, not recruiting NCT04704674 - Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia
Completed NCT03276962 - Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age Phase 2
Completed NCT04966871 - Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults Phase 1
Completed NCT00289185 - Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants Phase 2
Recruiting NCT03937817 - Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
Active, not recruiting NCT06153862 - Africa Ready Malaria Screening N/A
Completed NCT04545905 - Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso
Recruiting NCT06278181 - Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
Completed NCT02909712 - Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania Phase 2
Completed NCT02793622 - Prevention of Malaria in HIV-uninfected Pregnant Women and Infants Phase 3
Withdrawn NCT02793388 - A Trial on Supervised Primaquine Use in Ethiopia Phase 4
Withdrawn NCT02793414 - Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
Completed NCT02315690 - Evaluation of Reactive Focal Mass Drug Administration for Malaria Elimination in Swaziland Phase 3