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

Karolinska University Hospital

Status and phase: Completed; Phase 4

Conditions: Uncomplicated Plasmodium Falciparum Malaria

Treatments: Device: Rapid diagnostic test for malaria

Study type: Interventional

Funder types: Other

Identifiers

NCT00301015

RapAct 28-02-2006

Details and patient eligibility

About

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.

Enrollment: 3,005 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

3,005 participants in 2 patient groups

1

Experimental group

Description:

Malaria diagnosis aided with rapid diagnostic test

Treatment:

Device: Rapid diagnostic test for malaria

2

Active Comparator group

Description:

Malaria diagnosis based on clinical judgement only

Treatment:

Device: Rapid diagnostic test for malaria