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

This study has been completed.
Sponsor:
Collaborators:
Health Protection and Research Organisation
HealthNet TPO
Medical Emergency Relief International (Merlin)
Information provided by (Responsible Party):
Mark Rowland, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00935688
First received: July 8, 2009
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Malaria
Fever
Other: Rapid diagnostic test
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: An Examination of ACT Strategy in South-central Asia on Falciparum Malaria in a Context Where Vivax is the Major Species

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Proportion of patients correctly treated [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]

    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 [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
  • Diagnostic Accuracy of the different malaria tests [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
    Sensitivity and specificity of mRDTs, Microscopy and clinical diagnosis.


Enrollment: 4200
Study Start Date: May 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rapid diagnostic tests
malaria diagnosis by rapid diagnostic test
Other: Rapid diagnostic test
Dual species test for P. vivax and P. falciparum malaria
No Intervention: Clinic Microscopy
malaria diagnosed with field light-microscopy
No Intervention: Clinical Diagnosis
Malaria diagnosed on the basis of clinical symptoms alone (i.e. not laboratory diagnosis)

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935688

Locations
Afghanistan
HealthNet TPO
Jalalabad, Nangahar, Afghanistan
Merlin
Kunduz, Afghanistan
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Health Protection and Research Organisation
HealthNet TPO
Medical Emergency Relief International (Merlin)
Investigators
Principal Investigator: Toby Leslie, PhD LSHTM
  More Information

No publications provided

Responsible Party: Mark Rowland, Principle Investigator, Professor of Entomology and Malaria Control, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00935688     History of Changes
Other Study ID Numbers: ACT Consortium
Study First Received: July 8, 2009
Last Updated: February 6, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Afghanistan: Ministry of Public Health

Keywords provided by London School of Hygiene and Tropical Medicine:
malaria
rapid diagnostic tests
afghanistan
Non-specific fever

Additional relevant MeSH terms:
Fever
Malaria
Body Temperature Changes
Signs and Symptoms
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on April 17, 2014