Examination of ACT Implementation in a Vivax / Falciparum Co-endemic Area
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00935688|
Recruitment Status : Completed
First Posted : July 9, 2009
Last Update Posted : February 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Malaria Fever||Other: Rapid diagnostic test||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||An Examination of ACT Strategy in South-central Asia on Falciparum Malaria in a Context Where Vivax is the Major Species|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
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)
- Proportion of patients correctly treated [ Time Frame: 2009-2010 ]
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 ]
- Diagnostic Accuracy of the different malaria tests [ Time Frame: 2009-2010 ]Sensitivity and specificity of mRDTs, Microscopy and clinical diagnosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935688
|Jalalabad, Nangahar, Afghanistan|
|Principal Investigator:||Toby Leslie, PhD||LSHTM|