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

Kintampo Health Research Centre, Ghana

Status and phase: Completed; Phase 4

Conditions: Malaria

Treatments: Device: RDT; Other: Clinical Judgement as basis for treatment of malaria with ACT

Study type: Interventional

Funder types: Other

Identifiers

NCT00832754

KHRC1

Details and patient eligibility

About

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.

Full description

Two-stage, four component study Stage I - Component A: Accuracy of RDT and the outcome of treatment based on RDT results Primary outcome:What is the sensitivity and specificity of Paracheck cassettes in Ghana to diagnose malaria?

Stage 1 - Component B: delivery system determinants of effective RDT based ACT Primary outcome: What are the delivery system determinants of effective RDT based ACT?

Stage 2 - Component A: effects of restricted use of ACTs based on RDT results: a randomised controlled trial Primary outcome: Incidence of malaria (fever + any level of parasite density) in < 48 month-old children

Stage 2 - component B: Cost effectiveness analysis:

Primary outcome:What is the cost effectiveness of RDT based ACT for treatment of children under 4 years compared with ACT based on clinical judgement?

Enrollment: 3,063 patients

Sex: All

Ages: Under 48 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All children aged less than 48mths reporting to health center with suspected malaria

Exclusion criteria

• Children having chronic illnesses such as severe malnutrition and heart disease will be excluded from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,063 participants in 2 patient groups

RDT+ACT group

Experimental group

Description:

RDT+ACT group (ACT offered to RDT positive cases only)

Treatment:

Other: Clinical Judgement as basis for treatment of malaria with ACT

Device: RDT

Clinical judgement+ACT group

Active Comparator group

Description:

Clinical judgement+ACT group (ACT offered to all suspected cases of malaria by clinical judgement)

Treatment:

Other: Clinical Judgement as basis for treatment of malaria with ACT

Device: RDT