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.|
|ClinicalTrials.gov Identifier: NCT01166932|
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : November 1, 2010
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|
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 (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|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|
|Primary Completion Date :||April 2007|
|Study Completion Date :||April 2009|
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.
- length of stay at pediatric ward. [ Time Frame: 3 years ]
- need for broadening the spectrum antimicrobials. [ Time Frame: 3 years ]
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 ClinicalTrials.gov identifier (NCT number): NCT01166932
|Cristiane Franco Ribeiro|
|Botucatu, Sao Paulo, Brazil, 18.618-970|
|Principal Investigator:||Cristiane F Ribeiro, MD||UNESP - Botucatu Medical School|