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

December 20, 2012 updated by: Kintampo Health Research Centre, Ghana

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Actual)

3063

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
    • BAR
      • Kintampo, BAR, Ghana, 200
        • Kintampo Health Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RDT+ACT group
RDT+ACT group (ACT offered to RDT positive cases only)
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.
Active Comparator: Clinical judgement+ACT group
Clinical judgement+ACT group (ACT offered to all suspected cases of malaria by clinical judgement)
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kintampo Health Research Centre, Ghana

Collaborators

London School of Hygiene and Tropical Medicine

Investigators

  • Principal Investigator: Christopher Whitty, London School of Hygiene and Tropical Medicine
  • Principal Investigator: Frank E Baiden, Kintampo Health Research Center
  • Principal Investigator: Jayne Webster, London School of Hygiene and Tropical Medicine
  • Principal Investigator: Seth Owusu-Agyei, Kintampo Health Research Center
  • Principal Investigator: Daniel Chandramohan, London School of Hygiene and Tropical Medicine
  • Principal Investigator: Jane Bruce, London School of Hygiene and Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

January 30, 2009

Study Record Updates

Last Update Posted (Estimate)

December 21, 2012

Last Update Submitted That Met QC Criteria

December 20, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHRC1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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