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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720811
• Other study ID #: A60487
• Status: Completed
• Phase: N/A
• First received: July 21, 2008
• Last updated: March 15, 2012
• Start date: October 2009
• Est. completion date: January 2012

Study information

• Verified date: March 2012
• Source: Mbarara University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Nations: World Health Organization
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6456
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Months to 59 Months

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Malaria
• Pneumonia

Intervention

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
• amoxycillin
amoxycillin 250mg tab 4-12 months: 1/2x2; 13-35 months: 1x2; 36-59 months: 11/2x2
• 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

Locations

Country	Name	City	State
Burkina Faso	Sapone Site	Sapone
Ghana	Kassena Nankana Site	Kassana
Uganda	Iganga Site	Iganga
Uganda	Mbarara Site	Mbarara

Sponsors (5)

Lead Sponsor	Collaborator
Mbarara University of Science and Technology	Makerere University, Ministry of Health, Uganda, National Malaria Research and Training Centre, Burkina Faso, Navrongo Health Research Centre, Ghana

Countries where clinical trial is conducted

Burkina Faso,  Ghana,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery rate from fever at Day 3		Day 3	No
Secondary	use of antimalarial and antibiotic drugs by community health workers		After patient enrollment	No
Secondary	Recovery rate from fever at Day 7		Day 7	No