Working… Menu
Trial record 16 of 19 for:    Infections | Oxacillin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01166932
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : November 1, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Community-Acquired Pneumonia Drug: Amoxycillin/clavulanic acid Drug: ceftriaxone/oxacillin Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
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 Start Date : April 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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.

Primary Outcome Measures :
  1. length of stay at pediatric ward. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. need for broadening the spectrum antimicrobials. [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   2 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01166932

Layout table for location information
Cristiane Franco Ribeiro
Botucatu, Sao Paulo, Brazil, 18.618-970
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Layout table for investigator information
Principal Investigator: Cristiane F Ribeiro, MD UNESP - Botucatu Medical School

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jose Roberto Fioretto, UNESP HC FM Botucatu Unesp Identifier: NCT01166932     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-44
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: November 1, 2010
Last Verified: October 2010
Keywords provided by UPECLIN HC FM Botucatu Unesp:
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Clavulanic Acids
Clavulanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors