NSAIDs Treatment in Children With Pleuropneumonia

NCT ID: NCT01586299

Last Updated: 2014-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pleuro-pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ibuprofen

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

10 mg/kg every 8 hours until 24 hours after resolution of fever

acetaminophen

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

15 mg/kg every 6 hours until 24 hours after resolution of fever

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ibuprofen

10 mg/kg every 8 hours until 24 hours after resolution of fever

Intervention Type DRUG

Acetaminophen

15 mg/kg every 6 hours until 24 hours after resolution of fever

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

nurofen advil paracetamol acamol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

havatzelet yarden-bilavsky, MD

Role: PRINCIPAL_INVESTIGATOR

schneider children MC of Israel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Schneider's medical center of Israel

Petah Tikva, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

shai ashkenazi, Prof

Role: CONTACT

972-3-9253680

havatzelet yarden-bilavsky, Dr

Role: CONTACT

972-54-6777054

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Havatzelet -- Yarden-Bilavski, MD

Role: primary

+972-3-9253680

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

262-11-RMC

Identifier Type: -

Identifier Source: org_study_id