Status:
COMPLETED
Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia
Lead Sponsor:
KEMRI-Wellcome Trust Collaborative Research Program
Collaborating Sponsors:
University of Oxford
London School of Hygiene and Tropical Medicine
Conditions:
Pneumonia
Eligibility:
All Genders
2-59 years
Phase:
PHASE3
Brief Summary
This study seeks to determine whether clinical outcome following initial treatment of severe pneumonia with oral amoxicillin is as effective as the current standard benzyl penicillin. The study will a...
Detailed Description
Case management for the treatment of childhood acute respiratory infections has been widely promoted in many developing countries for over 20 years. Despite this, pneumonia continues to claim over 1.5...
Eligibility Criteria
Inclusion
- Clinical signs of WHO-defined severe pneumonia
- Age 2 months to 59 months
Exclusion
- Clinical signs of WHO-defined very severe pneumonia
- Clinical or laboratory diagnosis of meningitis
- Clinical diagnosis of severe malnutrition (marasmus/kwashiorkor)
- Clinical or laboratory diagnosis of severe anaemia requiring transfusion
- HIV-exposure on rapid HIV antibody test (only observational data will be collected from these patients)
- Elimination of signs of severe pneumonia in a child with wheeze after outpatient bronchodilator therapy
- Chronic condition that may underlie or contribute to a presentation with respiratory distress such as: known chronic renal or cardiac disease, presence of cerebral palsy predisposing child to aspiration/hypostatic pneumonia
- Established bronchiectasis or congenital abnormality of the lower respiratory tract
- Upper airway obstruction producing stridor
- Admission from outpatient clinic specifically for treatment of TB
- Referral from another inpatient facility following treatment with injectable antibiotics for more than 24 hours or because the initial regimen is considered to have failed
- Documented history of \>48hours treatment with oral amoxicillin
- Failure to obtain informed consent
- Penicillin allergy
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
561 Patients enrolled
Trial Details
Trial ID
NCT01399723
Start Date
September 1 2011
End Date
September 1 2013
Last Update
February 13 2015
Active Locations (6)
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1
Kerugoya District Hospital
Kerugoya, Central, Kenya
2
Embu Provincial General Hospital
Embu, Eastern, Kenya
3
Mbagathi District Hospital
Nairobi, Nairobi County, Kenya
4
Kisumu East District Hospital
Kisumu, Nyanza, Kenya