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

Overview

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 Title of Study: “Effects of Restricting the Use of AS-AQ Combination Therapy to Malaria Cases Confirmed by a Dipstick Test: A Cluster Randomised Control Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2012

Detailed 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?

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.

Arms, Groups and Cohorts

  • Experimental: RDT+ACT group
    • RDT+ACT group (ACT offered to RDT positive cases only)
  • Active Comparator: Clinical judgement+ACT group
    • Clinical judgement+ACT group (ACT offered to all suspected cases of malaria by clinical judgement)

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of malaria (fever + any level of parasite density) in < 48 month-old children (Stage 2, Component A)
    • Time Frame: Three years

Secondary Measures

  • Incidence of severe anaemia (Hb <8 g/dl) in < 48 month old children
    • Time Frame: Three years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 48 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kintampo Health Research Centre, Ghana
  • Collaborator
    • London School of Hygiene and Tropical Medicine
  • Provider of Information About this Clinical Study
    • Prof. Daniel Chandramohan, London School of Hygiene and Tropical Medicine
  • Overall Official(s)
    • Frank E Baiden, Principal Investigator, Kintampo Health Research Center
    • Jayne Webster, Principal Investigator, London School of Hygiene and Tropical Medicine
    • Christopher Whitty, Principal Investigator, London School of Hygiene and Tropical Medicine
    • Seth Owusu-Agyei, Principal Investigator, Kintampo Health Research Center
    • Daniel Chandramohan, Principal Investigator, London School of Hygiene and Tropical Medicine
    • Jane Bruce, Principal Investigator, London School of Hygiene and Tropical Medicine

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