Malaria Clinical Trial
Official title:
Introducing Rapid Diagnostic Tests Into the Private Health Sector in Uganda: a Randomised Trial Among Registered Drug Shops to Evaluate Impact on Antimalarial Drug Use
Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor
access to health facilities, home management of malaria (HMM) can improve the timeliness of
treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and
impact, artemisinin combination therapies (ACTs) should be deployed in HMM programmes, as
well as in formal health facilities. Up to 80% of malaria cases are treated outside the
formal health sector and shops are frequently visited as the first (and in some cases only)
source of treatment. Strategies to deploy ACTs in Africa thus also need to examine the role
of shops in home management and to ensure that drugs sold are appropriate. The current
practice of presumptive treatment of any febrile illness as malaria (both at health
facilities and in the context of HMM) based solely on clinical symptoms without routine
laboratory confirmation, results in significant over-use of antimalarial drugs. With ACT
being a more costly regimen, it is important to be more restrictive in its administration
and rapid diagnostic tests (RDTs) provide a simple means of confirming malaria diagnosis in
remote locations lacking electricity and qualified health staff.
This study therefore proposes to evaluate the feasibility, acceptability, and
cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by ocal drug
shops in an area with high malaria transmission.
Status | Completed |
Enrollment | 2600 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month and older |
Eligibility |
Inclusion Criteria: - Patients with fever - uncomplicted malaria Exclusion Criteria: - Complicated malaria - known allergic reactions to Lumartem |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Uganda | Mukono District | Mukono |
Lead Sponsor | Collaborator |
---|---|
DBL -Institute for Health Research and Development | Artemisinin-based Combination Therapy, London School of Hygiene and Tropical Medicine, Ministry of Health, Uganda |
Uganda,
Chandler CI, Hall-Clifford R, Asaph T, Pascal M, Clarke S, Mbonye AK. Introducing malaria rapid diagnostic tests at registered drug shops in Uganda: limitations of diagnostic testing in the reality of diagnosis. Soc Sci Med. 2011 Mar;72(6):937-44. doi: 10.1016/j.socscimed.2011.01.009. Epub 2011 Feb 3. — View Citation
Mbonye AK, Ndyomugyenyi R, Turinde A, Magnussen P, Clarke S, Chandler C. The feasibility of introducing rapid diagnostic tests for malaria in drug shops in Uganda. Malar J. 2010 Dec 21;9:367. doi: 10.1186/1475-2875-9-367. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Appropriateness of treatment | 36 months | No | |
Secondary | Appropriateness of referral of complicated malaria cases | 36 months | No |
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