Comparison Between Amoxycillin/Clavulanic Acid and Oxacillin/Ceftriaxone for Community Acquired-pneumonia
NCT ID: NCT01166932
Last Updated: 2010-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
104 participants
INTERVENTIONAL
2005-04-30
2009-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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amoxicillin/clavulanic acid
patients who received amoxicillin/clavulanic acid
Amoxycillin/clavulanic acid
100mg/Kg/day/10 days.
ceftriaxone/oxacillin
ceftriaxone/oxacillin
75 mg/Kg/day/10 days.
Interventions
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Amoxycillin/clavulanic acid
100mg/Kg/day/10 days.
ceftriaxone/oxacillin
75 mg/Kg/day/10 days.
Eligibility Criteria
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Inclusion Criteria
* children diagnosed with severe community-acquired pneumonia, who require hospitalization.
Exclusion Criteria
* severe comorbidities
* children admitted at PICU
2 Months
5 Years
ALL
No
Sponsors
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UPECLIN HC FM Botucatu Unesp
OTHER
Responsible Party
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UNESP HC FM Botucatu Unesp
Principal Investigators
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Cristiane F Ribeiro, MD
Role: PRINCIPAL_INVESTIGATOR
UNESP - Botucatu Medical School
Locations
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Cristiane Franco Ribeiro
Botucatu, São Paulo, Brazil
Countries
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References
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Ribeiro CF, Ferrari GF, Fioretto JR. Antibiotic treatment schemes for very severe community-acquired pneumonia in children: a randomized clinical study. Rev Panam Salud Publica. 2011 Jun;29(6):444-50.
Other Identifiers
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upeclin/HC/FMB-Unesp-44
Identifier Type: -
Identifier Source: org_study_id