NCT01166932

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 21, 2010

Completed
Last Updated

November 1, 2010

Status Verified

October 1, 2010

Enrollment Period

2 years

First QC Date

May 11, 2010

Last Update Submit

October 29, 2010

Conditions

Community-Acquired Pneumonia

Keywords

pneumoniachildrenantibiotics

Outcome Measures

Primary Outcomes (1)

  • length of stay at pediatric ward.

    3 years

Secondary Outcomes (1)

  • need for broadening the spectrum antimicrobials.

    3 years

Study Arms (2)

amoxicillin/clavulanic acid

ACTIVE COMPARATOR

patients who received amoxicillin/clavulanic acid

Drug: Amoxycillin/clavulanic acid

ceftriaxone/oxacillin

ACTIVE COMPARATOR
Drug: ceftriaxone/oxacillin

Interventions

Amoxycillin/clavulanic acidDRUG

100mg/Kg/day/10 days.

amoxicillin/clavulanic acid
ceftriaxone/oxacillinDRUG

75 mg/Kg/day/10 days.

ceftriaxone/oxacillin

Eligibility Criteria

Age2 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children aged from 2 months to 5 years
  • children diagnosed with severe community-acquired pneumonia, who require hospitalization.

You may not qualify if:

  • chronical diseases
  • severe comorbidities
  • children admitted at PICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cristiane Franco Ribeiro

Botucatu, São Paulo, 18.618-970, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 21829969DERIVED

MeSH Terms

Conditions

Community-Acquired PneumoniaPneumonia

Interventions

Amoxicillin-Potassium Clavulanate CombinationCeftriaxoneOxacillin

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesLung Diseases

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsCefotaximeCephacetrileCephalosporinsThiazines

Study Officials

  • Cristiane F Ribeiro, MD

    UNESP - Botucatu Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2010

First Posted

July 21, 2010

Study Start

April 1, 2005

Primary Completion

April 1, 2007

Study Completion

April 1, 2009

Last Updated

November 1, 2010

Record last verified: 2010-10

Locations

BR(1)