NSAIDs Treatment in Children With Pleuropneumonia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2012 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01586299
First received: March 19, 2012
Last updated: April 25, 2012
Last verified: January 2012
  Purpose

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).


Condition Intervention
Pleuro-pneumonia
Drug: Ibuprofen
Drug: Acetaminophen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of Non Steroidal Anti Inflammatory Drugs in the Treatment of Pleuropneumonia in Children. a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • clinical improvement as manifested by resolution of fever and length of hospital admission. [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical improvement as manifested by respiratory parameters (tachypnea, dyspnea, Fio2),and inflammatory markers. [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ibuprofen Drug: Ibuprofen
10 mg/kg every 8 hours until 24 hours after resolution of fever
Other Names:
  • nurofen
  • advil
Active Comparator: acetaminophen Drug: Acetaminophen
15 mg/kg every 6 hours until 24 hours after resolution of fever
Other Names:
  • paracetamol
  • acamol

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586299

Contacts
Contact: shai ashkenazi, Prof 972-3-9253680 sashkenazi@clalit.org.il
Contact: havatzelet yarden-bilavsky, Dr 972-54-6777054 yojiby@gmail.com

Locations
Israel
Schneider's medical center of Israel Not yet recruiting
Petah Tikva, Israel
Contact: Havatzelet -- Yarden-Bilavski, MD    +972-3-9253680    yoji@netvision.net.il   
Principal Investigator: Havatzelet -- Yarden-Bilavski, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: havatzelet yarden-bilavsky, MD schneider children MC of Israel
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01586299     History of Changes
Other Study ID Numbers: 262-11-RMC
Study First Received: March 19, 2012
Last Updated: April 25, 2012
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Rabin Medical Center:
pleuropneumonia children
non steroidal anti inflammatory drugs
pleural effusion
severe pneumonia

Additional relevant MeSH terms:
Pleurisy
Pneumonia
Pleuropneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pleural Diseases
Anti-Inflammatory Agents
Ibuprofen
Acetaminophen
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Antipyretics
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014