Examination of ACT Implementation in a Vivax / Falciparum Co-endemic Area
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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 |
- Proportion of patients incorrectly treated [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
- % of PV patients not receiving CQ % of PF patients not receiving SP/AS [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
| 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 |
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| Afghanistan | |
| HealthNet TPO | |
| Jalalabad, Nangahar, Afghanistan | |
| Merlin | |
| Kunduz, Afghanistan | |
| Principal Investigator: | Toby Leslie, PhD | LSHTM |
More Information
No publications provided
| Responsible Party: | Dr Mark Rowland, Principal Investigator, London School of Hygiene & Tropical Medicine, London, UK |
| ClinicalTrials.gov Identifier: | NCT00935688 History of Changes |
| Other Study ID Numbers: | ACT Consortium |
| Study First Received: | July 8, 2009 |
| Last Updated: | October 25, 2010 |
| 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 May 23, 2013