Clinical trial NCT00832754: Restricting the Use of Artesunate Plus Amodiaquine Combination Therapy to Malaria Cases Confirmed by a Dipstick Test: A Cluster Randomised Control Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Keywords: malaria
rapid diagnostic test
artemisinin
Ghana
Lead sponsor: Kintampo Health Research Centre, Ghana
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
First posted: 2009-01-30
Enrollment: 3063
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Incidence of malaria (fever + any level of parasite density) in < 48 month-old children (Stage 2, Component A)
timeFrame: Three years
Secondary outcomes:
measure: Incidence of severe anaemia (Hb <8 g/dl) in < 48 month old children
timeFrame: Three years
Other outcomes:
Locations:
city: Kintampo
country: Ghana
facility: Kintampo Health Research Center
state: BAR
Study officials:
affiliation: Kintampo Health Research Center
name: Frank E Baiden
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Jayne Webster
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Christopher Whitty
role: PRINCIPAL_INVESTIGATOR
affiliation: Kintampo Health Research Center
name: Seth Owusu-Agyei
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Daniel Chandramohan
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Jane Bruce
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tawiah T, Hansen KS, Baiden F, Bruce J, Tivura M, Delimini R, Amengo-Etego S, Chandramohan D, Owusu-Agyei S, Webster J. Cost-Effectiveness Analysis of Test-Based versus Presumptive Treatment of Uncomplicated Malaria in Children under Five Years in an Area of High Transmission in Central Ghana. PLoS One. 2016 Oct 3;11(10):e0164055. doi: 10.1371/journal.pone.0164055. eCollection 2016.
citation: Baiden F, Bruce J, Webster J, Tivura M, Delmini R, Amengo-Etego S, Owusu-Agyei S, Chandramohan D. Effect of Test-Based versus Presumptive Treatment of Malaria in Under-Five Children in Rural Ghana--A Cluster-Randomised Trial. PLoS One. 2016 Apr 7;11(4):e0152960. doi: 10.1371/journal.pone.0152960. eCollection 2016.
citation: Baiden F, Webster J, Tivura M, Delimini R, Berko Y, Amenga-Etego S, Agyeman-Budu A, Karikari AB, Bruce J, Owusu-Agyei S, Chandramohan D. Accuracy of rapid tests for malaria and treatment outcomes for malaria and non-malaria cases among under-five children in rural Ghana. PLoS One. 2012;7(4):e34073. doi: 10.1371/journal.pone.0034073. Epub 2012 Apr 13.