Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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 also provide an estimate of the proportion of Kenyan children with severe pneumonia who fail treatment with a single antibiotic.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KEMRI-Wellcome Trust Collaborative Research Program
• Collaborators: London School of Hygiene and Tropical Medicine; University of Nairobi; University of Oxford
• Treatments: Amoxicillin; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine; Penicillins

Criteria

Inclusion Criteria:

• Clinical signs of WHO-defined severe pneumonia

• Age 2 months to 59 months

Exclusion Criteria:

• 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