A Randomised Trial of Rapid Diagnostic Tests in the Diagnosis of Malaria in Tanzania
There is clear evidence diagnosis of malaria in much of Africa is sub-optimal and this has a negative impact on patient care. Many of those treated for malaria do not have it. Rapid diagnostic tests (RDTs) are dipsticks which diagnose malaria rapidly and accurately. The main objective of this trial is to determine by means of a randomised trial the impact of introducing RDTs into a standard outpatient setting in Tanzania has on the appropriate prescription of antimalarials. Other objectives are:
- To compare at high, moderate and low P.falciparum transmission intensity the sensitivity and specificity of malaria diagnosis using hospital slide results and RDTs, using research quality slides as the reference.
- To estimate the specificity of clinical diagnosis of malaria at high, moderate and low transmission intensity of P. falciparum.
- To compare the proportion of cases reported as slide-negative who are treated for malaria with the proportion of RDT-negative cases treated for malaria.
- To evaluate the cost effectiveness of introducing RDTs compared to current diagnostic practice in facilities with microscopic diagnosis of malaria at different levels of transmission of P.falciparum.
Device: Rapid diagnostic test for malaria
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Randomised Trial of Rapid Diagnostic Tests in the Diagnosis of Non-Severe Malaria at Different Transmission Intensities of Plasmodium Falciparum in Tanzania|
- The proportion of slide negative cases given an antimalarial (overprescription of antimalarials) in the RDT arm compared to the standard care arm.
- The proportion of slide positives not given an antimalarial who are slide positive (underprescription of antimalarials).
- Proportion of cases who are treated for malaria on clinical grounds alone
- Sensitivity and specificity of RDT and hospital malaria slide compared to double read research slide results.
- The proportion of patients receiving additional or alternative treatments to antimalarials following a negative blood slide or RDT result. This will inform cost-effectiveness models
|Study Start Date:||January 2005|
|Study Completion Date:||November 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146796
|Kilimanjaro Christian Medical College|
|Moshi, Tanzania, Private Bag|
|Principal Investigator:||Christopher Whitty, FRCP||London School of Hygiene and Tropical Medicine|