Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Introducing Rapid Diagnostic Tests Into the Private Health Sector

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:
NCT01194557
First received: September 2, 2010
Last updated: October 11, 2012
Last verified: October 2012

September 2, 2010
October 11, 2012
September 2010
July 2012   (final data collection date for primary outcome measure)
Appropriateness of treatment [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01194557 on ClinicalTrials.gov Archive Site
Appropriateness of referral of complicated malaria cases [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Introducing Rapid Diagnostic Tests Into the Private Health Sector
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Fever
  • Malaria
  • Diagnosis
  • Referral
  • Device: Rapid diagnostic test
    Diagnosis of malaria using rapid diagnostic test
  • Drug: Lumartem
    Presumptive treatment of malaria/fever
  • Active Comparator: rapid diagnostic test
    Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests
    Interventions:
    • Device: Rapid diagnostic test
    • Drug: Lumartem
  • No Intervention: Presumptive malaria treatment
    Presumptive treatment for malaria in drug shops

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2600
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with fever
  • uncomplicted malaria

Exclusion Criteria:

  • Complicated malaria
  • known allergic reactions to Lumartem
Both
1 Month and older
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT01194557
ACTUGA3
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: Anthony K Mbonye, PhD 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