Introducing Rapid Diagnostic Tests Into the Private Health Sector
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ClinicalTrials.gov Identifier: NCT01194557 |
Recruitment Status :
Completed
First Posted : September 3, 2010
Last Update Posted : October 12, 2012
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fever Malaria Diagnosis Referral | Device: Rapid diagnostic test Drug: Lumartem | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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 |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |

Arm | Intervention/treatment |
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Active Comparator: rapid diagnostic test
Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests
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Device: Rapid diagnostic test
Diagnosis of malaria using rapid diagnostic test Drug: Lumartem Presumptive treatment of malaria/fever |
No Intervention: Presumptive malaria treatment
Presumptive treatment for malaria in drug shops
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- Appropriateness of treatment [ Time Frame: 36 months ]
- Appropriateness of referral of complicated malaria cases [ Time Frame: 36 months ]

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Ages Eligible for Study: | 1 Month and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with fever
- uncomplicted malaria
Exclusion Criteria:
- Complicated malaria
- known allergic reactions to Lumartem

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194557
Uganda | |
Mukono District | |
Mukono, Uganda |
Principal Investigator: | Anthony K Mbonye, PhD | Ministry of Health, Uganda |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pascal Magnussen, Senior Researcher, DBL -Institute for Health Research and Development |
ClinicalTrials.gov Identifier: | NCT01194557 |
Other Study ID Numbers: |
ACTUGA3 |
First Posted: | September 3, 2010 Key Record Dates |
Last Update Posted: | October 12, 2012 |
Last Verified: | October 2012 |
history of fever measured fever appropriate treatment appropriate referral |
Malaria Fever Protozoan Infections Parasitic Diseases |
Infections Vector Borne Diseases Body Temperature Changes |