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

NCT00935688 | Completed Phase 4 DMC

• 1 other identifier: ACT Consortium
• Study Type: interventional
• Target: 4,200
• Locations: 1 country
• Sites: 2

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.

Conditions

Malaria; Fever

Keywords

malaria; rapid diagnostic tests; afghanistan; Non-specific fever

Outcome Measures

Primary Outcomes (1)

• Proportion of patients correctly treated

  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.

  2009-2010

Secondary Outcomes (2)

• % of PV patients not receiving CQ % of PF patients not receiving SP/AS

  2009-2010

• Diagnostic Accuracy of the different malaria tests

  2009-2010

Study Arms (3)

Rapid diagnostic tests

EXPERIMENTAL

malaria diagnosis by rapid diagnostic test

Other: Rapid diagnostic test

Clinic Microscopy

NO INTERVENTION

malaria diagnosed with field light-microscopy

Clinical Diagnosis

NO INTERVENTION

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

Interventions

Rapid diagnostic test OTHER

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

Rapid diagnostic tests

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Health Protection and Research Organisation: collaborator
• HealthNet TPO: collaborator
• Medical Emergency Relief International (Merlin): collaborator

Study Sites (2)

Merlin

Kunduz, Kunduz, Afghanistan

Location

HealthNet TPO

Jalalabad, Nangarhar, Afghanistan

Location

Related Publications (2)

• 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.

  PMID: 26016871 DERIVED

• 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.

  PMID: 24948695 DERIVED

MeSH Terms

Conditions

Malaria; Fever

Interventions

Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Body Temperature Changes; Signs and Symptoms; 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

• Toby Leslie, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Professor of Entomology and Malaria Control

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 9, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

AF (2)