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

This study has been completed.
Sponsor:
Collaborator:
Kilimanjaro Christian Medical Centre, Tanzania
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00146796
First received: September 5, 2005
Last updated: July 3, 2007
Last verified: September 2005
  Purpose

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
Malaria
Febrile Illness
Device: Rapid diagnostic test for malaria
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00146796

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

Publications:
ClinicalTrials.gov Identifier: NCT00146796     History of Changes
Other Study ID Numbers: ITIMVG38
Study First Received: September 5, 2005
Last Updated: July 3, 2007
Health Authority: Tanzania: Ministry of Health

Keywords provided by Gates Malaria Partnership:
Malaria
Diagnosis
RDT
Africa
Tanzania

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on October 19, 2014