Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs
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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 |
- Recovery rate from fever at Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
- 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 |
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| Burkina Faso | |
| Sapone Site | |
| Sapone, Burkina Faso | |
| Ghana | |
| Kassena Nankana Site | |
| Kassana, Ghana | |
| Uganda | |
| Iganga Site | |
| Iganga, Uganda | |
| Mbarara Site | |
| Mbarara, Uganda | |
| 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 Pneumonia Protozoan Infections Parasitic Diseases Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Acetaminophen Amoxicillin Anti-Bacterial Agents Artemether Lumefantrine Artemether-lumefantrine combination Artemisinins Antipyretics |
Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Infective Agents Antifungal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Coccidiostats Schistosomicides |
ClinicalTrials.gov processed this record on June 17, 2013