NSAIDs Treatment in Children With Pleuropneumonia | NCT01586299

Studies
NSAIDs Treatment in Children With Pleuropneumonia

NCT01586299

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Nov 14, 2014Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Pleuro-pneumonia

Interventions

Ibuprofen
Acetaminophen

Countries

Israel

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

Jan 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Jun 2015Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Mar 19, 2012

First Submission Date that Met QC Criteria

Apr 25, 2012

First Posted Date

Apr 26, 2012Estimated

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

Nov 13, 2014

Last Update Posted Date

Nov 14, 2014Estimated

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

The purpose of this study is to evaluate the influence of routine NSAIDs treatment for hospitalized children with pleuropneumonia in comparison with acetominophen treatment (all in conjunction with adequate antibiotic therapy).

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ibuprofen	Experimental		Drug: Ibuprofen
acetaminophen	Active Comparator		Drug: Acetaminophen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ibuprofen	Drug	10 mg/kg every 8 hours until 24 hours after resolution of fever	ibuprofen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical improvement as manifested by resolution of fever and length of hospital admission.		participants will be followed for the duration of hospital stay, an expected average of 10 days

Secondary Outcomes

Measure	Description	Time Frame
clinical improvement as manifested by respiratory parameters (tachypnea, dyspnea, Fio2),and inflammatory markers.		participants will be followed for the duration of hospital stay, an expected average of 10 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age less than 18 years
admission in Schneider childrenMC of Israel, wards a/c
clinical diagnosis of pneumonia with evidence of pleural effusion on chest X-ray
parental informed consent
follow-up ability after discharge

Exclusion Criteria:

pneumonia secondary to foreign body aspiration
immune deficiency
chronic lung disease other than asthma (CF, CLD of prematurity, Familial Dysautonomia, etc)
significant premorbidity (organ failure, rheumatic disease, etc)
endotracheal/endobronchial devices including tracheostomy.
parental refusal to participate in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
shai ashkenazi, Prof	Contact	972-3-9253680		sashkenazi@clalit.org.il
havatzelet yarden-bilavsky, Dr	Contact	972-54-6777054		yojiby@gmail.com

Overall Officials

Name	Affiliation	Role
havatzelet yarden-bilavsky, MD	schneider children MC of Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schneider's medical center of Israel	Recruiting	Petah Tikva			Israel

Condition Browse Module

MeSH Terms

ID	Term
D010996	Pleural Effusion
D011014	Pneumonia

Ancestor Terms

ID	Term
D010995	Pleural Diseases
D012140	Respiratory Tract Diseases
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007052	Ibuprofen
D000082	Acetaminophen

Ancestor Terms

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided