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

NCT00832754 | Completed Phase 4 DMC

• 1 other identifier: KHRC1
• Study Type: interventional
• Target: 3,063
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

malaria; rapid diagnostic test; artemisinin; Ghana

Outcome Measures

Primary Outcomes (1)

• Incidence of malaria (fever + any level of parasite density) in < 48 month-old children (Stage 2, Component A)

  Three years

Secondary Outcomes (1)

• Incidence of severe anaemia (Hb <8 g/dl) in < 48 month old children

  Three years

Study Arms (2)

RDT+ACT group

EXPERIMENTAL

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

Device: RDT; Other: Clinical Judgement as basis for treatment of malaria with ACT

Clinical judgement+ACT group

ACTIVE COMPARATOR

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

Device: RDT; Other: Clinical Judgement as basis for treatment of malaria with ACT

Interventions

RDT 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+ACT group; RDT+ACT group

Clinical Judgement as basis for treatment of malaria with ACT 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; RDT+ACT group

Eligibility Criteria

• Age: Up to 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children aged less than 48mths reporting to health center with suspected malaria

You may not qualify if:

• Children having chronic illnesses such as severe malnutrition and heart disease will be excluded from the study.

Sponsors & Collaborators

• Kintampo Health Research Centre, Ghana: lead
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Kintampo Health Research Center

Kintampo, BAR, 200, Ghana

Location

Related Publications (3)

• 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.

  PMID: 27695130 DERIVED

• 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.

  PMID: 27055275 DERIVED

• 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.

  PMID: 22514617 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: January 30, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

GH (1)