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

UPECLIN HC FM Botucatu Unesp

Status and phase: Completed; Phase 4

Conditions: Community-Acquired Pneumonia

Treatments: Drug: Amoxycillin/clavulanic acid; Drug: ceftriaxone/oxacillin

Study type: Interventional

Funder types: Other

Identifiers

NCT01166932

upeclin/HC/FMB-Unesp-44

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 2 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

amoxicillin/clavulanic acid

Active Comparator group

Description:

patients who received amoxicillin/clavulanic acid

Treatment:

Drug: Amoxycillin/clavulanic acid

ceftriaxone/oxacillin

Active Comparator group

Treatment:

Drug: ceftriaxone/oxacillin