Introducing Rapid Diagnostic Tests Into the Private Health Sector

DBL -Institute for Health Research and Development

Status: Completed

Conditions: Fever; Referral; Diagnosis; Malaria

Treatments: Device: Rapid diagnostic test; Drug: Lumartem

Study type: Interventional

Funder types: Other

Identifiers

NCT01194557

ACTUGA3

Details and patient eligibility

About

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.

Enrollment: 2,600 patients

Sex: All

Ages: 1+ month old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with fever
• uncomplicted malaria

Exclusion criteria

• Complicated malaria
• known allergic reactions to Lumartem

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,600 participants in 2 patient groups

rapid diagnostic test

Active Comparator group

Description:

Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests

Treatment:

Drug: Lumartem

Device: Rapid diagnostic test

Presumptive malaria treatment

No Intervention group

Description:

Presumptive treatment for malaria in drug shops