Restricting the Use of Artesunate Plus Amodiaquine Combination Therapy to Malaria Cases Confirmed by a Dipstick Test: A Cluster Randomised Control Trial (RDT-ACT)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
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| Ghana | |
| Kintampo Health Research Center | |
| Kintampo, BAR, Ghana, 200 | |
| 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 May 19, 2013