Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by Community Health Workers

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00301015

Enrollment

3005

Registered

2006-03-10

Start date

2006-03-31

Completion date

2006-08-31

Last updated

2007-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated Plasmodium Falciparum Malaria

Brief summary

The purpose of this study is to evaluate the efficiency of a rapid diagnostic test (Paracheck Pf) for the diagnosis of uncomplicated Plasmodium falciparum malaria by community health workers at village level in Tanzania and how the use of rapid diagnostic test may influence prescription of antimalarial drugs. The hypothesis is that rapid diagnostic tests used by community health workers will reduce the use of antimalarial drugs (Coartem; Novartis) by 30% without affecting the health outcome.

Interventions

DEVICERapid diagnostic test for malaria

We used Paracheck Pf® (Orchid Biomedical Systems, India) as rapid diagnostic test in this trial

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Fever * Informed consent

Exclusion criteria

* Severe clinical manifestations, which require immediate referral * Pregnancy * Previous enrollment in the study within the last 28 days

Design outcomes

Primary

Measure	Time frame
Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups	28 days

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026