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
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 4,200 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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