drugset / Trial / NCT00720811

Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs

NCT00720811

RandomizedParallel-groupOpen-labelTreatment

Summary

This study is to assess the value of incorporating a malaria RDT based strategy in HMM. The primary activity of the study wil be a two armed cluster randomised trial in two study sites in Uganda, one in Ghana and one in Burkina Faso. One of the Uganda sites is highly endemic and the other meso-endemic for malaria. In one arm the children will be treated presumptively for malaria with ACT (control arm) and the other arm the children will receive ACT only when they have a positive RDT result (implementation arm). The children in the implementation arm will also receive antibiotics if they have a raised respiratory rate. The primary outcome will be the recovery rate in the intervention arm compared to that of the control arm on Day 3. In addition, an acceptability assessment of RDTs in the community will be undertaken both before and after the intervention trial and a cost-effectiveness analysis of the RDT strategy will also be completed. For a sub-sample, microscopy slides will also be taken on Day 0 to demonstrate comparable levels of endemicity in control and intervention groups. These activities will be carried out over a two year period.

Timeline

Start
2009-10
Primary completion
2012-01
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 250 mg
Comparator Artemether Small molecule 20 mg
Comparator lumefantrine Small molecule 120 mg
Background Acetaminophen Small molecule 500 mg

Indications