Ignite Creation Date:
2024-05-05 @ 10:41 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01166932
Status:
COMPLETED
Last Update Posted:
2010-11-01
First Post:
2010-05-11
Brief Title:
Comparison Between AmoxycillinClavulanic Acid and OxacillinCeftriaxone for Community Acquired-pneumonia
Sponsor:
UPECLIN HC FM Botucatu Unesp
Organization:
UPECLIN HC FM Botucatu Unesp
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None