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OpenTrials
Completed

NCT Number: NCT00935688

Examination of ACT Implementation in a Vivax / Falciparum Co-endemic Area

In areas of which are co-endemic for vivax and falciparum malaria, treatments for the two diseases often differ and this may lead to mistreatment. This places an emphasis on diagnosis at the health service provision level. Diagnosis is also important when malaris endemicity is low - most fevers are not caused by disease. These two issues mean that most malaria and fevers are not adequately treated, even though the drugs may be effective; many patients who do not have malaria are treated for the disease, and patients with malaria may get the wrong treatment for their species. The study aims to test the effectiveness of employing rapid diagnostic tests and will study the effect on correct treatment.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Merlin, Kunduz, Afghanistan

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About this study

The study will randomly assign diagnostic methods, either with clinical diagnosis, field microscopy or rapid diagnostic tests. The study will take place in 22 clinics in Eastern and Northern Afghanistan, both areas with low transmission of predominantly vivax malaria. They differ in their locations and their current standard diagnostic methods.

The study will examine the result of the diagnostic test in the clinic against the result of reference slides and PCR to estimate the number of cases correctly treated in each arm. This will be a measure of the effectiveness of diagnosis (and the physicians response to the diagnosis) and be influential in considering modalities for diagnostic delivery

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient where the clinician* considers malaria in the diagnosis - either prescribing an antimalarial or would request a malaria test if available or referring for diagnosis of malaria elsewhere.
  • Patient, or parent/guardian, gives informed consent to the study.

Exclusion criteria

  • Patients with a result from another facility
  • Patients referred on for diagnosis in the private sector
  • Patients the clinician decides to treat presumptively without requesting a test (defined as treating prior to randomisation)
  • Where the clinician requests microscopy specifically due to clinical need prior to randomisation will not be randomised in the trial, but will be noted as part of the study and a reference slide and clinical information will be taken following consent.

Treatment and study plan

Rapid diagnostic test

Other

Dual species test for P. vivax and P. falciparum malaria

Primary outcomes

  1. Proportion of patients correctly treated

    Time frame: 2009-2010

    Composite measure defined as patients with Pf malaria receiving ACT Drugs; Pv malaria receiving CQ; patients with no malaria receiving no antimalarial drugs.

    NOTE: Previously reported here as "Proportion of patients incorrectly treated" being 1 minus the Proportion correctly treated. No change in how the outcome was measured.

Secondary outcomes

  1. % of PV patients not receiving CQ % of PF patients not receiving SP/AS

    Time frame: 2009-2010

  2. Diagnostic Accuracy of the different malaria tests

    Time frame: 2009-2010

    Sensitivity and specificity of mRDTs, Microscopy and clinical diagnosis.

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Health Protection and Research Organisation
  • HealthNet TPO
  • Medical Emergency Relief International (Merlin)

Registry information

Official study title

An Examination of ACT Strategy in South-central Asia on Falciparum Malaria in a Context Where Vivax is the Major Species

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 9, 2009
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.