Community Acquired Bacterial PneumoniaPhase 3NCT00202826
Study of Fluid Collection of the Chest in Children With Pneumonia
A Phase 3 study testing Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage in people with Community Acquired Bacterial Pneumonia and Paraneumonic Effusion, run by Corewell Health West at 1 site in United States.
Trial summary
The purpose of this study is to determine the best treatment for children with a fluid collection in the chest associated with an underlying pneumonia. Researchers generally agree that a child with a large fluid collection in the chest need to have the fluid drained in addition to anitbiotics. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Community Acquired Bacterial Pneumonia, Paraneumonic Effusion
- What is being tested?
- Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Mar 2004
- Phase
- Phase 3
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- consecutive pediatric patients with a bacterial pneumonia and parapneumonic effusion
- community acquired disease
- children age 0 to 18 years
Who cannot join
- hospital acquired pneumonia
- thoracentesis or chest tube drainage outside hospital
- patients with incorrected cardiac disease
Trial locations and contacts
1 site in 1 country.
United States1 site
DeVos Children's Hospital
Grand Rapids, Michigan, 49503
About this study
Official title: Parapneumonic Effusion in Children Study
The purpose of this study is to determine the best treatment for children with a fluid collection in the chest associated with an underlying pneumonia. Researchers generally agree that a child with a large fluid collection in the chest need to have the fluid drained in addition to anitbiotics. There have been many treatments studied in children that have been shown to be effective and safe, but the treatments have never been compared to each other in a randomized controlled study.
The optimal treatment of pediatric parapneumonic effusions remains controversial. The objective of this study is to compare the use of conventional management (antibiotics with thoracostomy tube placement) with primary thorascopic drainage (see protocol). Our hypothesis is that pediatric patients with parapneumonic effusion, regardless of pleural fluid composition and loculations, have decreased morbidity when treated with early thoroscopic adhesiolysis (VATS) compared with conservative treatment.
Read the detailed description
The ultimate objective of this study is to rationalize treatment decisions. It is our hope that this pilot study will provide the basis for further randomized prospective studies. The expected benefit is that the current treatment and outcome of pediatric parapneumonic effusions will be determined. Insights into the therapy that results in the least morbidity, hospital days, (and therefore cost) will be elucidated. If our hypothesis is valid, then a more aggressive surgical approach to the treatment of a parapneumonic effusion may be warranted. If the hypothesis is not valid, then the appropriate treatment for a parapneumonic effusion, irrespective of institution and personal opinion, should become more apparent.
- Being tested
- Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & DrainageProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
establish morbidity outcomes
duration of fever
number of procedures
days with a chest drainage device
total hospital days
Secondary outcomes (4)
Days of oxygen requirement
Days of narcotic use
Complication rate
Number of radiographic procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired Bacterial 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Collaborators
- Helen DeVos Children's Hospital
- Investigators
- John Winters, MD, Principal investigator, Helen DeVos Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202826
- Sponsor's protocol ID
- 2003-181
- Status last verified
- Jan 2009
- First submitted
- 13 Sep 2005
- Last updated
- 6 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parapneumonic Effusion in Children Study
- ClinicalTrials.gov ID
- NCT00202826
- Acronym / sponsor ID
- 2003-181
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Collaborators
- Helen DeVos Children's Hospital
- Study start
- Nov 2003
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 20 Sep 2005 (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 determine the best treatment for children with a fluid collection in the chest associated with an underlying pneumonia. Researchers generally agree that a child with a large fluid collection in the chest need to have the fluid drained in addition to anitbiotics. There have been many treatments studied in children that have been shown to be effective and safe, but the treatments have never been compared to each other in a randomized controlled study.
The optimal treatment of pediatric parapneumonic effusions remains controversial. The objective of this study is to compare the use of conventional management (antibiotics with thoracostomy tube placement) with primary thorascopic drainage (see protocol). Our hypothesis is that pediatric patients with parapneumonic effusion, regardless of pleural fluid composition and loculations, have decreased morbidity when treated with early thoroscopic adhesiolysis (VATS) compared with conservative treatment.
Detailed description
The ultimate objective of this study is to rationalize treatment decisions. It is our hope that this pilot study will provide the basis for further randomized prospective studies. The expected benefit is that the current treatment and outcome of pediatric parapneumonic effusions will be determined. Insights into the therapy that results in the least morbidity, hospital days, (and therefore cost) will be elucidated. If our hypothesis is valid, then a more aggressive surgical approach to the treatment of a parapneumonic effusion may be warranted. If the hypothesis is not valid, then the appropriate treatment for a parapneumonic effusion, irrespective of institution and personal opinion, should become more apparent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- consecutive pediatric patients with a bacterial pneumonia and parapneumonic effusion
- community acquired disease
- children age 0 to 18 years
Key exclusion criteria (3 listed)
- hospital acquired pneumonia
- thoracentesis or chest tube drainage outside hospital
- patients with incorrected cardiac disease
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 |
|---|---|---|
| Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage | Procedure or surgery | – |
Primary outcome
establish morbidity outcomes
duration of fever
number of procedures
days with a chest drainage device
total hospital days
4 secondary outcomes
Days of oxygen requirement
Days of narcotic use
Complication rate
Number of radiographic procedures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
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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.
John Winters, MD principal investigator
Helen DeVos Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage in people with Community Acquired Bacterial Pneumonia and Paraneumonic Effusion, run by Corewell Health West at 1 site in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 6 Dec 2021. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
establish morbidity outcomes. The study lists 5 primary outcomes in all. 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 6 Dec 2021.