A Randomised Trial of Rapid Diagnostic Tests in the Diagnosis of Malaria in Tanzania
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|ClinicalTrials.gov Identifier: NCT00146796|
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : January 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Malaria Febrile Illness||Device: Rapid diagnostic test for malaria||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2005|
|Actual Study Completion Date :||November 2005|
- 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
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): NCT00146796
|Kilimanjaro Christian Medical College|
|Moshi, Tanzania, Private Bag|
|Principal Investigator:||Christopher Whitty, FRCP||London School of Hygiene and Tropical Medicine|