Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria

Malaria Clinical Trial

— ACTUGA2  

Official title:

Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria: Comparative Trials in Two Areas of High and Low Transmission in Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048801
• Other study ID #: ACTUGA2
• Status: Completed
• Phase: N/A
• First received: January 13, 2010
• Last updated: October 11, 2012
• Start date: March 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 Service
• 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, 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 community-based drug distributors.The accuracy of RDTs, and the acceptability of this approach, will be evaluated in both low and high transmission areas.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Months to 59 Months

Eligibility

Inclusion Criteria:

• Children aged between 6 months and 5 years (< 5 years)reported with fever by the mother/ caretaker of the child

• Children with uncomplicated malaria/ fever episodes

• Children whose mothers consent to participate

Exclusion Criteria:

• Children aged less 6 months or greater than 4 years (= 5 years)

• Children requiring referral to a health facility (severe malaria, complicated fever episode, convulsions/fits, loss of consciousness, and other danger signs)

• Children whose mothers refuse to consent

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fever
• Malaria

Intervention

Device:
• Rapid diagnostic test
Use of rapid daignostic tests for diagnosis of malaria

Other:
• presumptive malaria treatment
Treatment of malariabased on clinical diagnosis without use of diagnostic test

Locations

Country	Name	City	State
Uganda	Rukungiri District	Rukungiri

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 (1)

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	Proportion of patients given prompt effective treatment by CDDs: % of <5-year-old children diagnosed with malaria who receive appropriate ACT treatment within 24 hours of onset of malaria.		36 months	No
Secondary	Coverage of prompt effective treatment: % of <5-year-old children with fever who received ACT treatment within 24 hours of onset of malaria, measured through household surveys.		36 months	No