Examination of ACT Implementation in a Vivax / Falciparum Co-endemic Area
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||An Examination of ACT Strategy in South-central Asia on Falciparum Malaria in a Context Where Vivax is the Major Species|
- Proportion of patients correctly treated [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
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.
- % of PV patients not receiving CQ % of PF patients not receiving SP/AS [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
- Diagnostic Accuracy of the different malaria tests [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]Sensitivity and specificity of mRDTs, Microscopy and clinical diagnosis.
|Study Start Date:||May 2009|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: Rapid diagnostic tests
malaria diagnosis by rapid diagnostic test
Other: Rapid diagnostic test
Dual species test for P. vivax and P. falciparum malaria
No Intervention: Clinic Microscopy
malaria diagnosed with field light-microscopy
No Intervention: Clinical Diagnosis
Malaria diagnosed on the basis of clinical symptoms alone (i.e. not laboratory diagnosis)
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935688
|Jalalabad, Nangahar, Afghanistan|
|Principal Investigator:||Toby Leslie, PhD||LSHTM|