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

This study has been completed.
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by:
Kintampo Health Research Centre, Ghana
ClinicalTrials.gov Identifier:
NCT00832754
First received: January 29, 2009
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Malaria
Device: RDT
Other: Clinical Judgement as basis for treatment of malaria with ACT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Restricting the Use of AS-AQ Combination Therapy to Malaria Cases Confirmed by a Dipstick Test: A Cluster Randomised Control Trial

Resource links provided by NLM:


Further study details as provided by Kintampo Health Research Centre, Ghana:

Primary Outcome Measures:
  • Incidence of malaria (fever + any level of parasite density) in < 48 month-old children (Stage 2, Component A) [ Time Frame: Three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of severe anaemia (Hb <8 g/dl) in < 48 month old children [ Time Frame: Three years ] [ Designated as safety issue: Yes ]

Enrollment: 3063
Study Start Date: March 2009
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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?

  Eligibility

Ages Eligible for Study:   up to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00832754

Locations
Ghana
Kintampo Health Research Center
Kintampo, BAR, Ghana, 200
Sponsors and Collaborators
Kintampo Health Research Centre, Ghana
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Frank E Baiden Kintampo Health Research Center
Principal Investigator: Jayne Webster London School of Hygiene and Tropical Medicine
Principal Investigator: Christopher Whitty 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
  More Information

No publications provided by Kintampo Health Research Centre, Ghana

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Daniel Chandramohan, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00832754     History of Changes
Other Study ID Numbers: KHRC1
Study First Received: January 29, 2009
Last Updated: December 20, 2012
Health Authority: Ghana: Ministry of Health

Keywords provided by Kintampo Health Research Centre, Ghana:
malaria
rapid diagnostic test
artemisinin
Ghana

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on September 29, 2014