Clinical trial NCT00935688: Examination of ACT Implementation in a Vivax / Falciparum Co-endemic Area
Official title: An Examination of ACT Strategy in South-central Asia on Falciparum Malaria in a Context Where Vivax is the Major Species
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Fever
Keywords: malaria
rapid diagnostic tests
afghanistan
Non-specific fever
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Health Protection and Research Organisation
name: HealthNet TPO
name: Medical Emergency Relief International (Merlin)
First posted: 2009-07-09
Enrollment: 4200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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.

Primary outcomes:
measure: Proportion of patients correctly treated
timeFrame: 2009-2010
Secondary outcomes:
measure: % of PV patients not receiving CQ % of PF patients not receiving SP/AS
timeFrame: 2009-2010
measure: Diagnostic Accuracy of the different malaria tests
timeFrame: 2009-2010
Other outcomes:
Locations:
city: Jalalabad
country: Afghanistan
facility: HealthNet TPO
state: Nangahar
city: Kunduz
country: Afghanistan
facility: Merlin
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Toby Leslie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.