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

NCT00146796 | Completed Phase 4

• 1 other identifier: ITIMVG38
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.To estimate the specificity of clinical diagnosis of malaria at high, moderate and low transmission intensity of P. falciparum.
3. 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. 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.

Conditions

Malaria; Febrile Illness

Keywords

Malaria; Diagnosis; RDT; Africa; Tanzania

Outcome Measures

Secondary Outcomes (5)

• 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

Interventions

Rapid diagnostic test for malaria DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Kilimanjaro Christian Medical Centre, Tanzania: collaborator

Study Sites (1)

Kilimanjaro Christian Medical College

Moshi, Moshi, Private Bag, Tanzania

Location

Related Publications (2)

• Reyburn H, Mbatia R, Drakeley C, Carneiro I, Mwakasungula E, Mwerinde O, Saganda K, Shao J, Kitua A, Olomi R, Greenwood BM, Whitty CJ. Overdiagnosis of malaria in patients with severe febrile illness in Tanzania: a prospective study. BMJ. 2004 Nov 20;329(7476):1212. doi: 10.1136/bmj.38251.658229.55. Epub 2004 Nov 12.

  PMID: 15542534 BACKGROUND

• Reyburn H, Mbakilwa H, Mwangi R, Mwerinde O, Olomi R, Drakeley C, Whitty CJ. Rapid diagnostic tests compared with malaria microscopy for guiding outpatient treatment of febrile illness in Tanzania: randomised trial. BMJ. 2007 Feb 24;334(7590):403. doi: 10.1136/bmj.39073.496829.AE. Epub 2007 Jan 26.

  PMID: 17259188 RESULT

MeSH Terms

Conditions

Malaria; Disease

Interventions

Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Study Officials

• Christopher Whitty, FRCP

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2005
• First Posted: September 7, 2005
• Study Start: January 1, 2005
• Study Completion: November 1, 2005
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

TA (1)