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

Malaria Clinical Trial

— RDT-ACT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832754
• Other study ID #: KHRC1
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2009
• Last updated: December 20, 2012
• Start date: March 2009
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Kintampo Health Research Centre, Ghana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ghana: Ministry of Health
• Study type: Interventional

Clinical 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3063
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 48 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

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.

Locations

Country	Name	City	State
Ghana	Kintampo Health Research Center	Kintampo	BAR

Sponsors (2)

Lead Sponsor	Collaborator
Kintampo Health Research Centre, Ghana	London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of malaria (fever + any level of parasite density) in < 48 month-old children (Stage 2, Component A)		Three years	No
Secondary	Incidence of severe anaemia (Hb <8 g/dl) in < 48 month old children		Three years	Yes