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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
  Purpose

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.


Condition Intervention
Malaria
Pneumonia
Drug: Artemether-lumefantrine combination
Drug: amoxycillin
Drug: paracetamol
Device: malaria rapid diagnostic test, respiratory rate timer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs

Resource links provided by NLM:


Further study details as provided by Mbarara University of Science and Technology:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 6456
Study Start Date: October 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
No Intervention: Presumptive fever management
Presumptive treatment of malaria with ACTs. No antibiotic treatment available
Drug: Artemether-lumefantrine combination
20/120mg tablet arthermether-lumefantrine 4-35months: 1x2; 36-59months: 2x2

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.

  Eligibility

Ages Eligible for Study:   4 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720811

Locations
Burkina Faso
Sapone Site
Sapone, Burkina Faso
Ghana
Kassena Nankana Site
Kassana, Ghana
Uganda
Iganga Site
Iganga, Uganda
Mbarara Site
Mbarara, Uganda
Sponsors and Collaborators
Mbarara University of Science and Technology
Makerere University
Ministry of Health, Uganda
Navrongo Health Research Centre, Ghana
National Malaria Research and Training Centre, Burkina Faso
Investigators
Study Director: Francis Bajunirwe, MBChB PhD Mbarara University of Science and Technology
Study Director: George Pariyo, MB ChB, PhD Makerere University School of Public Health
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
  More Information

No publications provided

Responsible Party: Mbarara University of Science and Technology
ClinicalTrials.gov Identifier: NCT00720811     History of Changes
Other Study ID Numbers: A60487
Study First Received: July 21, 2008
Last Updated: March 15, 2012
Health Authority: United Nations: World Health Organization

Keywords provided by Mbarara University of Science and Technology:
Malaria ACT
Rapid
Diagnosis
Community
health
worker
Artemesinin
based
Combination
Therapy
Anti Malarial
Treatment
antibiotics

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections
Acetaminophen
Amoxicillin
Anti-Bacterial Agents
Antibiotics, Antitubercular
Artemether
Artemether-lumefantrine combination
Artemisinins
Lumefantrine
Analgesics
Analgesics, Non-Narcotic
Anthelmintics
Anti-Infective Agents
Antifungal Agents
Antimalarials
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Antipyretics
Antitubercular Agents
Central Nervous System Agents
Coccidiostats
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Schistosomicides
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014