Comparison Between Amoxycillin/Clavulanic Acid and Oxacillin/Ceftriaxone for Community Acquired-pneumonia
Information source: UPECLIN HC FM Botucatu Unesp
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Condition(s) targeted: Community-Acquired Pneumonia
Intervention: Amoxycillin/clavulanic acid (Drug); ceftriaxone/oxacillin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: UPECLIN HC FM Botucatu Unesp Official(s) and/or principal investigator(s):
Cristiane F Ribeiro, MD, Principal Investigator, Affiliation: UNESP - Botucatu Medical School
Summary
Objective: To compare the clinical effectiveness and hospital costs, the initial empirical
treatment, Oxacillin / Ceftriaxone and Amoxicillin / Clavulanate in children with Community
Acquired Pneumonia (CAP) severe.
Methods: Clinical prospective randomized study in children aged two months to five years of
age with a diagnosis of severe CAP, according to criteria of World Health Organization
(WHO), admitted to the Pediatrics Ward of the Hospital of the Medical School of Botucatu-
UNESP. We excluded children with comorbid disorders (primary and secondary immunodeficiency)
with acute or chronic kidney disease, referred patients receiving antibiotics proposal and
history of allergy to antibiotics proposed. We included 104 children who were randomized
into two groups to receive: Oxacillin / Ceftriaxone IV (GCO, n = 48) and Amoxicillin /
Clavulanate IV (GAA, n = 56). Patients of the GAA, after clinical improvement, has been
receiving the same oral antibiotic, and maintaining clinical stability, were discharged from
hospital, the GOC received any IV treatment. The outcomes analyzed were time to clinical
improvement (fever and tachypnea), duration of oxygen therapy, hospitalization time, need to
expand the antimicrobial spectrum progression to pleural effusion / empyema (DP / E) and
hospital costs. Treatment failure was determined by the need to expand the antimicrobial
spectrum after 48 hours of hospitalization.
Clinical Details
Official title: COMPARISON OF CLINICAL EFFICACY OF COMBINATION Amoxycillin Plus Clavulanic Acid and Oxacillin Plus Ceftriaxone for HOSPITAL TREATMENT OF COMMUNITY Acquired PNEUMONIA IN CHILDREN : A Randomized Clinical Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
Primary outcome: length of stay at pediatric ward.
Secondary outcome: need for broadening the spectrum antimicrobials.
Detailed description:
eligibility: Children aged two months to five years with diagnosis of severe community
acquired pneumonia, requiring hospitalization.
Outcomes measures: time to clinical improvement (respiratory rate and fever), duration of
oxygen therapy, length of stay in the Division of Pediatrics, evolution with clinical
complications, need for broadening the spectrum antimicrobials.
Eligibility
Minimum age: 2 Months.
Maximum age: 5 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- children aged from 2 months to 5 years
- children diagnosed with severe community-acquired pneumonia, who require
hospitalization.
Exclusion Criteria:
- chronical diseases
- severe comorbidities
- children admitted at PICU
Locations and Contacts
Cristiane Franco Ribeiro, Botucatu, Sao Paulo 18.618-970, Brazil
Additional Information
Starting date: April 2005
Last updated: October 29, 2010
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