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A Randomised Trial of Rapid Diagnostic Tests in the Diagnosis of Malaria in Tanzania

This study has been completed.
Kilimanjaro Christian Medical Centre, Tanzania
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine Identifier:
First received: September 5, 2005
Last updated: January 11, 2017
Last verified: January 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:

  1. 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.
  2. To estimate the specificity of clinical diagnosis of malaria at high, moderate and low transmission intensity of P. falciparum.
  3. 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.
  4. 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 Intervention Phase
Febrile Illness
Device: Rapid diagnostic test for malaria
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:

Further study details as provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:

Secondary Outcome Measures:
  • 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

Enrollment: 2400
Study Start Date: January 2005
Study Completion Date: November 2005
  Show Detailed Description


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. All patients of any age attending the outpatient facility will be eligible to be considered for the trial
  2. A clinician decision to request a malaria test.

Exclusion Criteria:

Where a clinician decides that they would prefer a hospital slide to the patient entering the trial- these cases will be noted but excluded from the trial.

Patients are admitted from outpatients to the ward Those who appear to the study clinical officer to be too distressed or ill to participate.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00146796

Kilimanjaro Christian Medical College
Moshi, Tanzania, Private Bag
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Kilimanjaro Christian Medical Centre, Tanzania
Principal Investigator: Christopher Whitty, FRCP London School of Hygiene and Tropical Medicine
  More Information

Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine Identifier: NCT00146796     History of Changes
Other Study ID Numbers: ITIMVG38
Study First Received: September 5, 2005
Last Updated: January 11, 2017

Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases processed this record on May 25, 2017