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

Information source: UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Page last updated: August 23, 2015

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