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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01166932
Other study ID # upeclin/HC/FMB-Unesp-44
Secondary ID
Status Completed
Phase Phase 4
First received May 11, 2010
Last updated October 29, 2010
Start date April 2005
Est. completion date April 2009

Study information

Verified date October 2010
Source UPECLIN HC FM Botucatu Unesp
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date April 2009
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group 2 Months to 5 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Amoxycillin/clavulanic acid
100mg/Kg/day/10 days.
ceftriaxone/oxacillin
75 mg/Kg/day/10 days.

Locations

Country Name City State
Brazil Cristiane Franco Ribeiro Botucatu Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
UPECLIN HC FM Botucatu Unesp

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary length of stay at pediatric ward. 3 years Yes
Secondary need for broadening the spectrum antimicrobials. 3 years Yes
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