Restricting the Use of Artesunate Plus Amodiaquine Combination Therapy to Malaria Cases Confirmed by a Dipstick Test: A Cluster Randomised Control Trial

Summary

Effective use of Rapid Diagnostic Test (RDT) and artemisinin-based combination therapy (ACT) depends on the accuracy and safety of RDT based treatment practices and on factors related to the health delivery system. We propose to study the accuracy and safety of RDT based diagnosis and treatment of febrile illness, health system determinants of effective use of RDTs and the public health outcomes of RDT based ACT for malaria.A cluster randomised trial of RDT based versus clinical judgment based treatment of febrile illness on the incidence of malaria in \<48 month old children will be conducted. Health Centres will be randomly allocated to RDT based treatment or clinical judgment based treatment arm and children under 2years of age from the catchment area of each health centre will be followed for 2 years. The cost effectiveness of RDT based approach will be compare with the clinical judgement based treatment.

Conditions

• Malaria

Interventions

DEVICE

RDT

Study children attending RDT+ACT HCs with a febrile illness will be tested with an RDT to confirm malaria and treated with ACT only if they have a positive test for malaria parasite. However if there are signs suggestive of other co-morbidities they will be treated with appropriate medicines in addition to AS+AQ.

OTHER

Clinical Judgement as basis for treatment of malaria with ACT

Study children attending RDT+ACT HCs with a febrile illness will be tested with an RDT to confirm malaria and treated with ACT only if they have a positive test for malaria parasite. However if there are signs suggestive of other co-morbidities they will be treated with appropriate medicines in addition to AS+AQ.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Kintampo Health Research Centre, Ghana

  lead OTHER

Principal Investigators

• Frank E Baiden · Kintampo Health Research Center

• Jayne Webster · London School of Hygiene and Tropical Medicine

• Christopher Whitty · London School of Hygiene and Tropical Medicine

• Seth Owusu-Agyei · Kintampo Health Research Center

• Daniel Chandramohan · London School of Hygiene and Tropical Medicine

• Jane Bruce · London School of Hygiene and Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

48 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2012-08-31

Completion

2012-12-31

Countries

• Ghana

Study Locations