Comparison Between Amoxycillin/Clavulanic Acid and Oxacil... | NCT01166932

Studies
Comparison Between Amoxycillin/Clavulanic Acid and Oxacillin/Ceftriaxone for Community Acquired-pneumonia

NCT01166932

Sponsor

UPECLIN HC FM Botucatu Unesp

Status

Completed

Last Update Posted

Nov 1, 2010Estimated

Enrollment

104Actual

Phase

Phase 4

Conditions

Community-Acquired Pneumonia

Interventions

Amoxycillin/clavulanic acid
ceftriaxone/oxacillin

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2009Actual

First Submitted Date

May 11, 2010

First Submission Date that Met QC Criteria

Jul 20, 2010

First Posted Date

Jul 21, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2010

Last Update Posted Date

Nov 1, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
amoxicillin/clavulanic acid	Active Comparator	patients who received amoxicillin/clavulanic acid	Drug: Amoxycillin/clavulanic acid
ceftriaxone/oxacillin	Active Comparator		Drug: ceftriaxone/oxacillin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amoxycillin/clavulanic acid	Drug	100mg/Kg/day/10 days.	amoxicillin/clavulanic acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
length of stay at pediatric ward.		3 years

Secondary Outcomes

Measure	Description	Time Frame
need for broadening the spectrum antimicrobials.		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cristiane F Ribeiro, MD	UNESP - Botucatu Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cristiane Franco Ribeiro		Botucatu	São Paulo	18.618-970	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21829969	Derived	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.

ID	Term
D017714	Community-Acquired Infections
D007239	Infections
D012141	Respiratory Tract Infections
D012140	Respiratory Tract Diseases

ID	Term
D019980	Amoxicillin-Potassium Clavulanate Combination
D002443	Ceftriaxone
D010068	Oxacillin

ID	Term
D019818	Clavulanic Acid
D002969	Clavulanic Acids
D047090	beta-Lactams
D007769	Lactams