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

October 29, 2010 updated by: UPECLIN HC FM Botucatu Unesp

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18.618-970
        • Cristiane Franco Ribeiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: amoxicillin/clavulanic acid
patients who received amoxicillin/clavulanic acid
Drug: Amoxycillin/clavulanic acid
100mg/Kg/day/10 days.
ACTIVE_COMPARATOR: ceftriaxone/oxacillin
Drug: ceftriaxone/oxacillin
75 mg/Kg/day/10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
length of stay at pediatric ward.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
need for broadening the spectrum antimicrobials.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UPECLIN HC FM Botucatu Unesp

Investigators

  • Principal Investigator: Cristiane F Ribeiro, MD, UNESP - Botucatu Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

April 1, 2007

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

July 20, 2010

First Posted (ESTIMATE)

July 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2010

Last Update Submitted That Met QC Criteria

October 29, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • upeclin/HC/FMB-Unesp-44

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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