Introducing Rapid Diagnostic Tests Into the Private Health Sector

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194557
• Other study ID #: ACTUGA3
• Status: Completed
• Phase: N/A
• First received: September 2, 2010
• Last updated: October 11, 2012
• Start date: September 2010
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: DBL -Institute for Health Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Services
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diagnosis
• Fever
• Malaria
• Referral

Intervention

Device:
• Rapid diagnostic test
Diagnosis of malaria using rapid diagnostic test

Drug:
• Lumartem
Presumptive treatment of malaria/fever

Locations

Country	Name	City	State
Uganda	Mukono District	Mukono

Sponsors (4)

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

Country where clinical trial is conducted

Uganda, 

References & Publications (2)

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

Outcome

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