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

Primary Purpose

Malaria, Fever

Status
Completed
Phase
Phase 4
Locations
Afghanistan
Study Type
Interventional
Intervention
Rapid diagnostic test
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malaria focused on measuring malaria, rapid diagnostic tests, afghanistan, Non-specific fever

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HealthNet TPO
  • Merlin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Rapid diagnostic tests

Clinic Microscopy

Clinical Diagnosis

Arm Description

malaria diagnosis by rapid diagnostic test

malaria diagnosed with field light-microscopy

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

% of PV patients not receiving CQ % of PF patients not receiving SP/AS
Diagnostic Accuracy of the different malaria tests
Sensitivity and specificity of mRDTs, Microscopy and clinical diagnosis.

Full Information

First Posted
July 8, 2009
Last Updated
February 6, 2014
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Health Protection and Research Organisation, HealthNet TPO, Medical Emergency Relief International (Merlin)
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1. Study Identification

Unique Protocol Identification Number
NCT00935688
Brief Title
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Health Protection and Research Organisation, HealthNet TPO, Medical Emergency Relief International (Merlin)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Fever
Keywords
malaria, rapid diagnostic tests, afghanistan, Non-specific fever

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapid diagnostic tests
Arm Type
Experimental
Arm Description
malaria diagnosis by rapid diagnostic test
Arm Title
Clinic Microscopy
Arm Type
No Intervention
Arm Description
malaria diagnosed with field light-microscopy
Arm Title
Clinical Diagnosis
Arm Type
No Intervention
Arm Description
Malaria diagnosed on the basis of clinical symptoms alone (i.e. not laboratory diagnosis)
Intervention Type
Other
Intervention Name(s)
Rapid diagnostic test
Intervention Description
Dual species test for P. vivax and P. falciparum malaria
Primary Outcome Measure Information:
Title
Proportion of patients correctly treated
Description
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.
Time Frame
2009-2010
Secondary Outcome Measure Information:
Title
% of PV patients not receiving CQ % of PF patients not receiving SP/AS
Time Frame
2009-2010
Title
Diagnostic Accuracy of the different malaria tests
Description
Sensitivity and specificity of mRDTs, Microscopy and clinical diagnosis.
Time Frame
2009-2010

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toby Leslie, PhD
Organizational Affiliation
LSHTM
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthNet TPO
City
Jalalabad
State/Province
Nangahar
Country
Afghanistan
Facility Name
Merlin
City
Kunduz
Country
Afghanistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26016871
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.
Results Reference
derived
PubMed Identifier
24948695
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.
Results Reference
derived

Learn more about this trial

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

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