A Phase 4 interventional study of Rapid diagnostic test in Malaria and Fever, sponsored by London School of Hygiene and Tropical Medicine. Completed at 2 sites in Afghanistan. Per ClinicalTrials.gov, last updated 2014-02-07.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 4, Interventional, and Diagnostic
In areas of which are co-endemic for vivax and falciparum malaria, treatments for the two diseases often differ and this may lead to mistreatment. This places an emphasis on diagnosis at the health service provision level. Diagnosis is also important when malaris endemicity is low - most fevers are not caused by disease. These two issues mean that most malaria and fevers are not adequately treated, even though the drugs may be effective; many patients who do not have malaria are treated for the disease, and patients with malaria may get the wrong treatment for their species. The study aims to test the effectiveness of employing rapid diagnostic tests and will study the effect on correct treatment.
The study will randomly assign diagnostic methods, either with clinical diagnosis, field microscopy or rapid diagnostic tests. The study will take place in 22 clinics in Eastern and Northern Afghanistan, both areas with low transmission of predominantly vivax malaria. They differ in their locations and their current standard diagnostic methods.
The study will examine the result of the diagnostic test in the clinic against the result of reference slides and PCR to estimate the number of cases correctly treated in each arm. This will be a measure of the effectiveness of diagnosis (and the physicians response to the diagnosis) and be influential in considering modalities for diagnostic delivery
Exclusion Criteria:
malaria diagnosis by rapid diagnostic test
Other: Rapid diagnostic test
malaria diagnosed with field light-microscopy
Malaria diagnosed on the basis of clinical symptoms alone (i.e. not laboratory diagnosis)
Dual species test for P. vivax and P. falciparum malaria
Proportion of patients correctly treated
Composite measure defined as patients with Pf malaria receiving ACT Drugs; Pv malaria receiving CQ; patients with no malaria receiving no antimalarial drugs. NOTE: Previously reported here as "Proportion of patients incorrectly treated" being 1 minus the Proportion correctly treated. No change in how the outcome was measured.
Time frame: 2009-2010
% of PV patients not receiving CQ % of PF patients not receiving SP/AS
Time frame: 2009-2010
Diagnostic Accuracy of the different malaria tests
Sensitivity and specificity of mRDTs, Microscopy and clinical diagnosis.
Time frame: 2009-2010
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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London School of Hygiene and Tropical Medicine