MedDataX Logo

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

NCT ID: NCT00832754

Last Updated: 2012-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3063 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malaria

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

malaria rapid diagnostic test artemisinin Ghana

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RDT+ACT group

RDT+ACT group (ACT offered to RDT positive cases only)

Group Type EXPERIMENTAL

RDT

Intervention Type DEVICE

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.

Clinical Judgement as basis for treatment of malaria with ACT

Intervention Type OTHER

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.

Clinical judgement+ACT group

Clinical judgement+ACT group (ACT offered to all suspected cases of malaria by clinical judgement)

Group Type ACTIVE_COMPARATOR

RDT

Intervention Type DEVICE

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.

Clinical Judgement as basis for treatment of malaria with ACT

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Kintampo Health Research Centre, Ghana

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

London School of Hygiene and Tropical Medicine

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Frank E Baiden

Role: PRINCIPAL_INVESTIGATOR

Kintampo Health Research Center

Jayne Webster

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Christopher Whitty

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Seth Owusu-Agyei

Role: PRINCIPAL_INVESTIGATOR

Kintampo Health Research Center

Daniel Chandramohan

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Jane Bruce

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kintampo Health Research Center

Kintampo, BAR, Ghana

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ghana

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27695130 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27055275 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22514617 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KHRC1

Identifier Type: -

Identifier Source: org_study_id