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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935688
• Other study ID #: ACT Consortium
• Status: Completed
• Phase: Phase 4
• First received: July 8, 2009
• Last updated: February 6, 2014
• Start date: May 2009
• Est. completion date: October 2010

Study information

• Verified date: February 2014
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyAfghanistan: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4200
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fever
• Malaria

Intervention

Other:
• Rapid diagnostic test
Dual species test for P. vivax and P. falciparum malaria

Locations

Country	Name	City	State
Afghanistan	HealthNet TPO	Jalalabad	Nangahar
Afghanistan	Merlin	Kunduz

Sponsors (4)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Health Protection and Research Organisation, HealthNet TPO, Medical Emergency Relief International (Merlin)

Country where clinical trial is conducted

Afghanistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	% of PV patients not receiving CQ % of PF patients not receiving SP/AS		2009-2010	No
Secondary	Diagnostic Accuracy of the different malaria tests	Sensitivity and specificity of mRDTs, Microscopy and clinical diagnosis.	2009-2010	No