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Completed

NCT Number: NCT01194557

Introducing Rapid Diagnostic Tests Into the Private Health Sector

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.

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Key information

Age range

1 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mukono District

Mukono, Uganda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with fever
  • uncomplicted malaria

Exclusion criteria

  • Complicated malaria
  • known allergic reactions to Lumartem

Treatment and study plan

Rapid diagnostic test

Device

Diagnosis of malaria using rapid diagnostic test

Lumartem

Drug

Presumptive treatment of malaria/fever

Primary outcomes

  1. Appropriateness of treatment

    Time frame: 36 months

Secondary outcomes

  1. Appropriateness of referral of complicated malaria cases

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

DBL -Institute for Health Research and Development

Other

Collaborators

  • Artemisinin-based Combination Therapy
  • London School of Hygiene and Tropical Medicine
  • Ministry of Health, Uganda

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 3, 2010
Registry last updated
Oct 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.