Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs

This study has been completed.

Sponsor:

Collaborators:

Makerere University

Ministry of Health, Uganda

Navrongo Health Research Centre, Ghana

National Malaria Research and Training Centre, Burkina Faso

Information provided by (Responsible Party):

Mbarara University of Science and Technology

ClinicalTrials.gov Identifier:

NCT00720811

First received: July 21, 2008

Last updated: March 15, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 21, 2008

Last Updated Date

March 15, 2012

Start Date ^ICMJE

October 2009

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Recovery rate from fever at Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00720811 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

use of antimalarial and antibiotic drugs by community health workers [ Time Frame: After patient enrollment ] [ Designated as safety issue: No ]
Recovery rate from fever at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Description of feasibility of using RDTs by the Community Medicine Distributors [ Time Frame: After patient enrollment ] [ Designated as safety issue: No ]
Recovery rate from fever at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs

Official Title ^ICMJE

Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs

Brief Summary

This study is to assess the value of incorporating a malaria RDT based strategy in HMM. The primary activity of the study wil be a two armed cluster randomised trial in two study sites in Uganda, one in Ghana and one in Burkina Faso. One of the Uganda sites is highly endemic and the other meso-endemic for malaria. In one arm the children will be treated presumptively for malaria with ACT (control arm) and the other arm the children will receive ACT only when they have a positive RDT result (implementation arm). The children in the implementation arm will also receive antibiotics if they have a raised respiratory rate. The primary outcome will be the recovery rate in the intervention arm compared to that of the control arm on Day 3. In addition, an acceptability assessment of RDTs in the community will be undertaken both before and after the intervention trial and a cost-effectiveness analysis of the RDT strategy will also be completed. For a sub-sample, microscopy slides will also be taken on Day 0 to demonstrate comparable levels of endemicity in control and intervention groups. These activities will be carried out over a two year period.

Detailed Description

This is an open, cluster randomised multicentre two arm trial in the three countries of Burkina Faso, Ghana and Uganda. Clusters are villages (catchment populations) of individual community health workers (CHWs). Within the study areas, clusters that are more than 5 km from a designate health facility where CHWs referred cases for special care will be excluded. A cluster randomized design was chosen over an individually randomized design to reduce contamination, facilitate supervision, reduce costs, and to ensure that the CHWs maintained the correct treatments based on the tests in the Intervention arm and the presumptive treatment in the Control arm.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Malaria
Pneumonia

Intervention ^ICMJE

Drug: Artemether-lumefantrine combination
20/120mg Artemether-lumefantrine 4-35 months: 1 tablet twice daily for 3 days; 36-59 months: 2 tablets twice daily for 3 days

Other Name: Coartem
Drug: amoxycillin
amoxycillin 250mg tab 4-12 months: 1/2x2; 13-35 months: 1x2; 36-59 months: 11/2x2
Drug: paracetamol
paracetamol 500mg tablet <36months: 1/4x4 for 2 days; 36-59months: 1/2x4 for 2 days
Device: malaria rapid diagnostic test, respiratory rate timer
malaria dipstick, and breath timer
Drug: Artemether-lumefantrine combination
20/120mg tablet arthermether-lumefantrine 4-35months: 1x2; 36-59months: 2x2

Study Arm (s)

Experimental: ACT, antibiotic, paracetamol
CHWs will test children with acute febrile illness for malaria using RDTs, and for pneumonia by counting their respiratory rate with RRTs. Treatment will then be provided on the basis of the test results, in line with national guidelines. Children with a positive RDT will receive artemether-lumefantrine in Burkina Faso and Uganda, and artesunate-amodiaquine in Ghana. Children with a cough and a high respiratory rate will receive amoxicillin in Ghana and Uganda, and cotrimoxazole in Burkina Faso. Additionally, paracetamol (PCT) will be provided to all children with an axillary temperature > 38.5°C.
Interventions:
- Drug: Artemether-lumefantrine combination
- Drug: amoxycillin
- Drug: paracetamol
- Device: malaria rapid diagnostic test, respiratory rate timer
No Intervention: Presumptive fever management
Presumptive treatment of malaria with ACTs. No antibiotic treatment available

Intervention: Drug: Artemether-lumefantrine combination

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

6456

Completion Date

January 2012

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Children between 4-59 months of age with a history of fever in the last 24 hours presenting to the community medicine distributor

Exclusion Criteria:

Children classified as having severe illness according to IMCI guidelines. Children suffering from Chronic disease(s), those with reported anti malarial or antibiotic treatment (intervention) arm in previous two weeks and those whose caregivers refuse to consent to participate

Gender

Both

Ages

4 Months to 59 Months (Child)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Burkina Faso, Ghana, Uganda

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00720811

Other Study ID Numbers ^ICMJE

A60487

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Mbarara University of Science and Technology

Study Sponsor ^ICMJE

Mbarara University of Science and Technology

Collaborators ^ICMJE

Makerere University
Ministry of Health, Uganda
Navrongo Health Research Centre, Ghana
National Malaria Research and Training Centre, Burkina Faso

Investigators ^ICMJE

Study Director:	Francis Bajunirwe, MBChB PhD	Mbarara University of Science and Technology
Study Director:	George Pariyo, MB ChB, PhD	Makerere University
Principal Investigator:	James Tibenderana, MB ChB, PhD	Malaria Consortium
Principal Investigator:	Alfred Tiono, PhD	National Malaria Research and Training Center, Burkina Faso
Principal Investigator:	Thomas Anyorigiya, MSc	Navrongo Health Research Centre, Ghana

Information Provided By

Mbarara University of Science and Technology

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top