Malaria
Conditions
Keywords
malaria, rapid diagnostic test, artemisinin, Ghana
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?
Interventions
DEVICERDT
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.
OTHERClinical 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.
Sponsors
London School of Hygiene and Tropical Medicine
Kintampo Health Research Centre, Ghana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 48 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of malaria (fever + any level of parasite density) in < 48 month-old children (Stage 2, Component A) | Three years |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of severe anaemia (Hb <8 g/dl) in < 48 month old children | Three years |
Countries
Ghana
Outcome results
None listed