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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00935688
Recruitment Status : Completed
First Posted : July 9, 2009
Last Update Posted : February 7, 2014
Health Protection and Research Organisation
HealthNet TPO
Medical Emergency Relief International (Merlin)
Information provided by (Responsible Party):
Mark Rowland, London School of Hygiene and Tropical Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malaria Fever Other: Rapid diagnostic test Phase 4

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: An Examination of ACT Strategy in South-central Asia on Falciparum Malaria in a Context Where Vivax is the Major Species
Study Start Date : May 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Malaria

Arm Intervention/treatment
Experimental: Rapid diagnostic tests
malaria diagnosis by rapid diagnostic test
Other: Rapid diagnostic test
Dual species test for P. vivax and P. falciparum malaria

No Intervention: Clinic Microscopy
malaria diagnosed with field light-microscopy
No Intervention: Clinical Diagnosis
Malaria diagnosed on the basis of clinical symptoms alone (i.e. not laboratory diagnosis)

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00935688

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HealthNet TPO
Jalalabad, Nangahar, Afghanistan
Kunduz, Afghanistan
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Health Protection and Research Organisation
HealthNet TPO
Medical Emergency Relief International (Merlin)
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Principal Investigator: Toby Leslie, PhD LSHTM
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mark Rowland, Principle Investigator, Professor of Entomology and Malaria Control, London School of Hygiene and Tropical Medicine Identifier: NCT00935688    
Other Study ID Numbers: ACT Consortium
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014
Keywords provided by Mark Rowland, London School of Hygiene and Tropical Medicine:
rapid diagnostic tests
Non-specific fever
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases