Pleuro-pneumoniaNCT01586299
NSAIDs Treatment in Children With Pleuropneumonia
A study testing Ibuprofen and Acetaminophen in people with Pleuro-pneumonia, run by Rabin Medical Center at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pleuro-pneumonia
- What is being tested?
- Ibuprofen and Acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schneider's medical center of Israel
Petah Tikva
Havatzelet -- Yarden-Bilavski, MD, +972-3-9253680, yoji@netvision.net.il
Havatzelet -- Yarden-Bilavski, MD
About this study
Official title: The Role of Non Steroidal Anti Inflammatory Drugs in the Treatment of Pleuropneumonia in Children. a Randomized Controlled Trial
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).
- Conditions
- Pleuro-pneumonia
- Being tested
- Ibuprofen, Acetaminophen
- Keywords
- pleuropneumonia children, non steroidal anti inflammatory drugs, pleural effusion, severe pneumonia
- Medical subject headings
- Pleural Effusion, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called nurofen, advil
10 mg/kg every 8 hours until 24 hours after resolution of fever
AcetaminophenDrug
Also called paracetamol, acamol
15 mg/kg every 6 hours until 24 hours after resolution of fever
| Study group | Role | What they receive |
|---|---|---|
| ibuprofen | Experimental | Not described Receives: Drug: Ibuprofen |
| acetaminophen | Active comparator | Not described Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical improvement as manifested by resolution of fever and length of hospital admission.
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary outcomes (1)
clinical improvement as manifested by respiratory parameters (tachypnea, dyspnea, Fio2),and inflammatory markers.
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleuro-pneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- havatzelet yarden-bilavsky, MD, Principal investigator, schneider children MC of Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586299
- Sponsor's protocol ID
- 262-11-RMC
- Status last verified
- Jan 2012
- First submitted
- 19 Mar 2012
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Non Steroidal Anti Inflammatory Drugs in the Treatment of Pleuropneumonia in Children. a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01586299
- Acronym / sponsor ID
- 262-11-RMC
- Conditions
- Pleuro-pneumonia
- Keywords
- pleuropneumonia children, non steroidal anti inflammatory drugs, pleural effusion, severe pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ibuprofen | Experimental | Drug: Ibuprofen |
| acetaminophen | Active comparator | Drug: Acetaminophen |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: nurofen, advil10 mg/kg every 8 hours until 24 hours after resolution of fever | Drug | ibuprofen |
| AcetaminophenAlso: paracetamol, acamol15 mg/kg every 6 hours until 24 hours after resolution of fever | Drug | acetaminophen |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
havatzelet yarden-bilavsky, MD principal investigator
schneider children MC of Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen and Acetaminophen in people with Pleuro-pneumonia, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shai ashkenazi, Prof (972-3-9253680, sashkenazi@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2014.