Text Size

Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria (ACTUGA2)

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, Uganda
London School of Hygiene and Tropical Medicine
Artemisinin based combination Therapies Consortium
Information provided by (Responsible Party):
Pascal Magnussen, DBL -Institute for Health Research and Development
ClinicalTrials.gov Identifier:
NCT01048801
First received: January 13, 2010
Last updated: October 11, 2012
Last verified: October 2012
History of Changes

January 13, 2010
October 11, 2012
March 2010
July 2012   (final data collection date for primary outcome measure)
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. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01048801 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria
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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Fever
  • Malaria
  • 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
  • Active Comparator: Rapid diagnostic test and treatment
    Intervention: Device: Rapid diagnostic test
  • Treatment without rapid daignostic test
    Intervention: Other: presumptive malaria treatment
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2000
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
5 Months to 59 Months
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT01048801
ACTUGA2
Yes
Pascal Magnussen, DBL -Institute for Health Research and Development
DBL -Institute for Health Research and Development
  • Ministry of Health, Uganda
  • London School of Hygiene and Tropical Medicine
  • Artemisinin based combination Therapies Consortium
Principal Investigator: Richard Ndyomugyenyi, MD Ministry of Health, Uganda
DBL -Institute for Health Research and Development
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP