Clinical Trial: Use of Rapid Diagnostic Tests for Malaria Case Management in Kenya

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Introduction of Malaria Rapid Diagnostic Tests, Artemisinin-based Combination Therapy, and Malaria Case Management Guidelines at Health Facili

Brief Summary: The purpose of this study is to investigate the impact of rapid diagnostic tests (RDTs) in the context of a newly implemented malaria case management guidelines using artemisinin-based combination therapy on the malaria prescribing practices of health care workers in Kenya.

Detailed Summary:

Malaria causes an estimated 300-500 million infections and over 1 million deaths per year, predominantly in children <5 years old in sub-Saharan Africa. In most parts of malaria endemic sub-Saharan Africa, clinical or presumptive diagnosis, often based on the presence of fever, is the primary means of diagnosing malaria. Clinical diagnosis is sensitive but poorly specific, leading to substantial over-diagnosis. Personnel and supplies to perform microscopic examination of blood smears of persons suspected of having malaria (the current gold standard for diagnosis of malaria) are not available at most health facilities. Over-diagnosis and subsequent over-treatment of patients as a result of clinical diagnosis can lead to increased drug pressure that may facilitate the development of drug resistance in P. falciparum, the malaria parasite responsible for most associated morbidity and mortality in sub-Saharan Africa. This may also increase costs, particularly with the shift from inexpensive antimalarials (such as chloroquine and sulfadoxine-pyrimethamine) to newer, more expensive artemisinin-based combination therapies (ACTs) (such as artemether plus lumefantrine, also known as Coartem®). Over-diagnosis also exposes patients to the unnecessary risk of adverse drug events and, among some patients, leaves the real cause of illness untreated.

Rapid diagnostic tests (RDTs) use immunochromatographic methods to detect antigens derived from malaria parasites in lysed blood. RDTs have generally been reported to achieve field sensitivities and specificities of >90% in the detection of Plasmodium falciparum at densities above 100 parasites/μL blood. RDTs are easy to use and interpret, do not require electricity or special equipment, and can be shipped and stored at ambient conditions.

We hypothesize the use of RDTs should
Sponsor: Centers for Disease Control and Prevention

Current Primary Outcome: Sensitivity and specificity of malaria diagnosis 6 weeks after the introduction of malaria rapid diagnostic tests

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adherence to malaria case management guidelines by health care workers
  • Cost effectiveness of malaria case management guidelines using malaria rapid diagnostic tests
  • Acceptability of malaria rapid diagnostic tests to health care workers
  • Acceptability of malaria rapid diagnostic tests to patients


Original Secondary Outcome: Same as current

Information By: Centers for Disease Control and Prevention

Dates:
Date Received: June 10, 2006
Date Started: July 2006
Date Completion:
Last Updated: March 8, 2010
Last Verified: March 2010