Pneumonia Clinical Trial
Official title:
Effect of Enhanced Feedback to Hospitals That Are Part of an Emerging Clinical Information Network on Uptake of Revised Childhood Pneumonia Treatment Policy: A Pragmatic Cluster Randomized Trial Protocol
Verified date | July 2017 |
Source | KEMRI-Wellcome Trust Collaborative Research Program |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A cluster randomised pragmatic trial will be conducted within an emerging clinical information network composed of 12 Kenyan county hospitals. Hospitals will be randomised to an enhanced feedback intervention delivered over a nine-month period and compared to standard feedback. The trial to be implemented during a phase of implementing change in guideline recommendations for pneumonia will assess the impact of enhanced feedback on hospital uptake of the revised pneumonia treatment recommendations.
Status | Completed |
Enrollment | 900 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 59 Months |
Eligibility |
Inclusion Criteria: - Children aged 2 to 59 months admitted to participating network hospitals with WHO pneumonia diagnosis eligible for treatment with oral amoxicillin Exclusion Criteria: - Children aged 2 to 59 months with WHO pneumonia diagnosis and co-morbid illnesses requiring intravenous antibiotic treatment including severe acute malnutrition, bacteraemia, meningitis, or - children presenting with pneumonia and tuberculosis or cough lasting more than 2 weeks, or severe malaria |
Country | Name | City | State |
---|---|---|---|
Kenya | Busia County Hospital | Busia | |
Kenya | Embu County Hospital | Embu | |
Kenya | Kakamega County Referral Hospital | Kakamega | |
Kenya | Vihiga County Hospital | Kakamega | |
Kenya | Karatina County Hospital | Karatina | |
Kenya | Kerugoya County Hospital | Kerugoya | |
Kenya | Kiambu County Hospital | Kiambu | |
Kenya | Kisumu County Hospital | Kisumu | |
Kenya | Kitale County Hospital | Kitale | |
Kenya | Machakos County Hospital | Machakos | |
Kenya | Mama Lucy Kibaki Hospital | Nairobi | |
Kenya | Nyeri County Hospital | Nyeri |
Lead Sponsor | Collaborator |
---|---|
KEMRI-Wellcome Trust Collaborative Research Program |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pneumonia classification and treatment | The proportion of all pneumonia admissions (fulfilling criteria for treatment with oral amoxicillin) who are correctly classified and treated using new guideline recommendations | 9 months | |
Secondary | Antibiotic change | The proportion of treatment change from oral amoxicillin to alternative antibiotics for pneumonia (considered a proxy measure of treatment failure) | 9 months |
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