Comparison Between Amoxycillin/Clavulanic Acid and Oxacillin/Ceftriaxone for Community Acquired-pneumonia
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.
|Community-Acquired Pneumonia||Drug: Amoxycillin/clavulanic acid Drug: ceftriaxone/oxacillin||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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|
- length of stay at pediatric ward. [ Time Frame: 3 years ]
- need for broadening the spectrum antimicrobials. [ Time Frame: 3 years ]
|Study Start Date:||April 2005|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Active Comparator: amoxicillin/clavulanic acid
patients who received amoxicillin/clavulanic acid
Drug: Amoxycillin/clavulanic acid
|Active Comparator: ceftriaxone/oxacillin||
75 mg/Kg/day/10 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166932
|Cristiane Franco Ribeiro|
|Botucatu, Sao Paulo, Brazil, 18.618-970|
|Principal Investigator:||Cristiane F Ribeiro, MD||UNESP - Botucatu Medical School|