Comparison Between Amoxycillin/Clavulanic Acid and Oxacillin/Ceftriaxone for Community Acquired-pneumonia
Primary Purpose
Community-Acquired Pneumonia
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Amoxycillin/clavulanic acid
ceftriaxone/oxacillin
Sponsored by
About this trial
This is an interventional treatment trial for Community-Acquired Pneumonia focused on measuring pneumonia, children, antibiotics
Eligibility 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
Sites / Locations
- Cristiane Franco Ribeiro
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
amoxicillin/clavulanic acid
ceftriaxone/oxacillin
Arm Description
patients who received amoxicillin/clavulanic acid
Outcomes
Primary Outcome Measures
length of stay at pediatric ward.
Secondary Outcome Measures
need for broadening the spectrum antimicrobials.
Full Information
NCT ID
NCT01166932
First Posted
May 11, 2010
Last Updated
October 29, 2010
Sponsor
UPECLIN HC FM Botucatu Unesp
1. Study Identification
Unique Protocol Identification Number
NCT01166932
Brief Title
Comparison Between Amoxycillin/Clavulanic Acid and Oxacillin/Ceftriaxone for Community Acquired-pneumonia
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 Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UPECLIN HC FM Botucatu Unesp
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-Acquired Pneumonia
Keywords
pneumonia, children, antibiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
amoxicillin/clavulanic acid
Arm Type
Active Comparator
Arm Description
patients who received amoxicillin/clavulanic acid
Arm Title
ceftriaxone/oxacillin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Amoxycillin/clavulanic acid
Intervention Description
100mg/Kg/day/10 days.
Intervention Type
Drug
Intervention Name(s)
ceftriaxone/oxacillin
Intervention Description
75 mg/Kg/day/10 days.
Primary Outcome Measure Information:
Title
length of stay at pediatric ward.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
need for broadening the spectrum antimicrobials.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristiane F Ribeiro, MD
Organizational Affiliation
UNESP - Botucatu Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cristiane Franco Ribeiro
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18.618-970
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
21829969
Citation
Ribeiro CF, Ferrari GF, Fioretto JR. Antibiotic treatment schemes for very severe community-acquired pneumonia in children: a randomized clinical study. Rev Panam Salud Publica. 2011 Jun;29(6):444-50.
Results Reference
derived
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Comparison Between Amoxycillin/Clavulanic Acid and Oxacillin/Ceftriaxone for Community Acquired-pneumonia
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