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

NCT01399723 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 561

Last updated 2015-02-13

Study results available
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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.

Conditions

Interventions

DRUG

Amoxicillin

Oral 45mg/kg 12 hourly

DRUG

Benzyl penicillin

Intravenous 50,000IU/kg 6 hourly

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • University of Nairobi

    collaborator OTHER

  • KEMRI-Wellcome Trust Collaborative Research Program

    lead OTHER

Principal Investigators

  • Ambrose Agweyu, MSc · Kemri- Wellcome Trust Research Programme, Nairobi, Kenya

  • Elizabeth Obimbo, MMed · Department of Paediatrics and Child Health, University of Nairobi, Nairobi, Kenya

  • Roma Chilengi, MD · Centre for Infectious Disease Research, Zambia

  • Tansy Edwards, MSc · London School of Hygiene and Tropical Medicine

  • Mike English, MD · Kemri - Wellcome Trust Research Programme, Nairobi, Kenya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01399723 on ClinicalTrials.gov