Comparison Between Amoxycillin/Clavulanic Acid and Oxacillin/Ceftriaxone for Community Acquired-pneumonia

Phase 4

Completed

• Conditions: Community-Acquired Pneumonia
• Interventions: Drug: Amoxycillin/clavulanic acid; Drug: ceftriaxone/oxacillin

• Registration Number: NCT01166932
• Lead Sponsor: UPECLIN HC FM Botucatu Unesp

Brief 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.

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.

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2007-04
• Study Completion: 2009-04
• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-21
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-29
• Last Update Posted: 2010-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amoxicillin/clavulanic acid	Amoxycillin/clavulanic acid	patients who received amoxicillin/clavulanic acid
ceftriaxone/oxacillin	ceftriaxone/oxacillin	-

Primary Outcome Measures

Name	Time	Method
length of stay at pediatric ward.	3 years

Secondary Outcome Measures

Name	Time	Method
need for broadening the spectrum antimicrobials.	3 years

Trial Locations

Locations (1)

Cristiane Franco Ribeiro; 🇧🇷 Botucatu, Sao Paulo, Brazil