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

NCT ID: NCT00935688

Last Updated: 2014-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 4200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-10-31

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.

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

Conditions

Malaria; Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Rapid diagnostic tests

malaria diagnosis by rapid diagnostic test

Group Type: EXPERIMENTAL

Rapid diagnostic test

Intervention Type: OTHER

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

Clinic Microscopy

malaria diagnosed with field light-microscopy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Clinical Diagnosis

Malaria diagnosed on the basis of clinical symptoms alone (i.e. not laboratory diagnosis)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rapid diagnostic test

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Protection and Research Organisation

UNKNOWN

Sponsor Role: collaborator

HealthNet TPO

OTHER

Sponsor Role: collaborator

Medical Emergency Relief International (Merlin)

UNKNOWN

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Mark Rowland

Principle Investigator, Professor of Entomology and Malaria Control

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Toby Leslie, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

Merlin

Kunduz, Kunduz, Afghanistan

HealthNet TPO

Jalalabad, Nangarhar, Afghanistan

Countries

Afghanistan

References

Hansen KS, Grieve E, Mikhail A, Mayan I, Mohammed N, Anwar M, Baktash SH, Drake TL, Whitty CJ, Rowland MW, Leslie TJ. Cost-effectiveness of malaria diagnosis using rapid diagnostic tests compared to microscopy or clinical symptoms alone in Afghanistan. Malar J. 2015 May 28;14:217. doi: 10.1186/s12936-015-0696-1.

Reference Type: DERIVED

PMID: 26016871 (View on PubMed)

Leslie T, Mikhail A, Mayan I, Cundill B, Anwar M, Bakhtash SH, Mohammed N, Rahman H, Zekria R, Whitty CJ, Rowland M. Rapid diagnostic tests to improve treatment of malaria and other febrile illnesses: patient randomised effectiveness trial in primary care clinics in Afghanistan. BMJ. 2014 Jun 19;348:g3730. doi: 10.1136/bmj.g3730.

Reference Type: DERIVED

PMID: 24948695 (View on PubMed)

Other Identifiers

ACT Consortium

Identifier Type: -

Identifier Source: org_study_id