Complicated Parapneumonic EffusionPhase 3NCT00234208
Early Medical Thoracoscopy Versus Simple Chest Tube Drainage in Complicated Parapneumonic Effusion and Pleural Empyema
A Phase 3 study testing Medical thoracoscopy and Simple chest tube drainage in people with Complicated Parapneumonic Effusion and Pleural Empyema, run by University Hospital, Basel, Switzerland at 5 sites in 3 countries.
Trial summary
Multicenter, randomized controlled study to compare early mini-invasive thoracoscopy to simple chest tube drainage in complicated parapneumonic effusions or pleural empyema. 100 patients will be recruited. Follow-up will be 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complicated Parapneumonic Effusion, Pleural Empyema
- What is being tested?
- Medical thoracoscopy and Simple chest tube drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Oct 2005to Jan 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Septated pleural effusion (ultrasonography) in the context of a lower respiratory tract infection
- Frank pleural empyema (pus)
Who cannot join
- Fibrothorax
- Tuberculous empyema
- Medical thoracoscopy cannot be performed within 24 hours
- Pregnancy
- Inability to give informed consent
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Italy3 sites
Pulmonology Unit, Spedali Civili di Brescia
Brescia, 25103
UO Pneumologia
Imperia, 18100
Pulmonology and Thoracic Endoscopy Unit Azienda Ospedaliera di Parma
Parma, 43100
Greece1 site
Department of Pneumology, University Hospital of Alexandroupolis
Alexandroupoli, 68100
About this study
Official title: A Randomized Controlled Study of Early Mini-invasive Medical Thoracoscopy Versus Simple Chest Tube Drainage in Complicated Parapneumonic Effusions or Pleural Empyema - ESMITE (European Study on Mini-invasive Thoracoscopy in Empyema)
Multicenter, randomized controlled study to compare early mini-invasive thoracoscopy to simple chest tube drainage in complicated parapneumonic effusions or pleural empyema. 100 patients will be recruited. Follow-up will be 3 months. It will be looked at the rate medical cure, the need for secondary interventions, death and duration of hospital stay. In a nested trial in 20 patients the intrapleural pharmacokinetics of linezolid (approved antibiotic agent) will be measured.
Read the detailed description
Background Pleural empyema has a high morbidity and mortality. Until now it is not clear which method is best to initially drain the pus, especially in complicated effusions with septa.
The objective of this study is to compare the standard treatment of simple chest tube drainage to early mini-invasive medical thoracoscopy. In earlier studies medical thoracoscopy has been a safe and effective method in pleural diseases. However there is no prospective data available.
Methods We conduct a prospective randomized controlled multicenter study on 100 patients with complicated parapneumonic effusions with septa or empyema with frank pus. Patients will be randomized to receive either simple chest tube drainage or early medical thoracoscopy. The latter will be performed in local anaesthesia and analgosedation according to the standards set by the European Study on Medical Video-Assisted Thoracoscopy (ESMEVAT)-group. Fibrinolysis will be used routinely. In 20 patients a nested study on the intrapleural pharmacokinetics of linezolid as antibiotic agent will be performed.
Follow-up will be structured on day 1, day 7, before discharge and after 3 months including chest radiographs and clinical and laboratory evaluations.
Outcome Primary outcome will be medical cure without the need of secondary intervention or death.
As secondary outcome we will measure duration of hospital stay, adverse events.
Provisional agenda Start of study: October 2005 End of study: October 2007
Potential outcome \& benefit The study should clarify the role of early medical thoracoscopy in patients with complicated parapneumonic effusions or pleural empyema. Different authors have speculated that early intervention could be preferable. On the other hand, in many centres worldwide patients are primarily treated by a simple chest tube with or without pleural fibrinolysis. In case of failure of simple drainage, but this means several "precious" days later, a more invasive procedure is needed. At that moment tight pleural septa have formed, and often a surgical VATS or thoracotomy in general anaesthesia becomes necessary. Therefore, this pivotal study could lead to changes in the management of patients with pleural empyema.
- Being tested
- Medical thoracoscopy, Simple chest tube drainage
- Keywords
- Complicated parapneumonic effusion, Pleural empyema, Intervention, Medical thoracoscopy, Chest tube drainage
- Medical subject headings
- Empyema, Pleural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical thoracoscopyProcedure or surgery
Simple chest tube drainageProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Medical thoracoscopy | Experimental | Not described Receives: Procedure: Medical thoracoscopy |
| Simple chest tube drainage | Active comparator | Not described Receives: Procedure: Simple chest tube drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical cure without secondary Intervention
Death
Secondary outcomes (7)
Duration of hospital stay
Radiological outcome
Duration of drainage
Total amount of drainage fluid
Estimated cost
Adverse events
Pleural pharmacokinetics of linezolid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionJan 2007
- Study completionJan 2007
Why it stopped: insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Parapneumonic EffusionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Lancardis Foundation, Pfizer
- Responsible party
- Sponsor
- Investigators
- Martin H Brutsche, MD, Prof., Principal investigator, Pneumology, Kantonsspital St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234208
- Sponsor's protocol ID
- EK 186/05
- Status last verified
- May 2016
- First submitted
- 5 Oct 2005
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Early Mini-invasive Medical Thoracoscopy Versus Simple Chest Tube Drainage in Complicated Parapneumonic Effusions or Pleural Empyema - ESMITE (European Study on Mini-invasive Thoracoscopy in Empyema)
- ClinicalTrials.gov ID
- NCT00234208
- Acronym / sponsor ID
- EK 186/05
- Keywords
- Complicated parapneumonic effusion, Pleural empyema, Intervention, Medical thoracoscopy, Chest tube drainage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Lancardis Foundation, Pfizer
- Study start
- Oct 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 6 Oct 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.
Multicenter, randomized controlled study to compare early mini-invasive thoracoscopy to simple chest tube drainage in complicated parapneumonic effusions or pleural empyema. 100 patients will be recruited. Follow-up will be 3 months. It will be looked at the rate medical cure, the need for secondary interventions, death and duration of hospital stay. In a nested trial in 20 patients the intrapleural pharmacokinetics of linezolid (approved antibiotic agent) will be measured.
Detailed description
Background Pleural empyema has a high morbidity and mortality. Until now it is not clear which method is best to initially drain the pus, especially in complicated effusions with septa.
The objective of this study is to compare the standard treatment of simple chest tube drainage to early mini-invasive medical thoracoscopy. In earlier studies medical thoracoscopy has been a safe and effective method in pleural diseases. However there is no prospective data available.
Methods We conduct a prospective randomized controlled multicenter study on 100 patients with complicated parapneumonic effusions with septa or empyema with frank pus. Patients will be randomized to receive either simple chest tube drainage or early medical thoracoscopy. The latter will be performed in local anaesthesia and analgosedation according to the standards set by the European Study on Medical Video-Assisted Thoracoscopy (ESMEVAT)-group. Fibrinolysis will be used routinely. In 20 patients a nested study on the intrapleural pharmacokinetics of linezolid as antibiotic agent will be performed.
Follow-up will be structured on day 1, day 7, before discharge and after 3 months including chest radiographs and clinical and laboratory evaluations.
Outcome Primary outcome will be medical cure without the need of secondary intervention or death.
As secondary outcome we will measure duration of hospital stay, adverse events.
Provisional agenda Start of study: October 2005 End of study: October 2007
Potential outcome \& benefit The study should clarify the role of early medical thoracoscopy in patients with complicated parapneumonic effusions or pleural empyema. Different authors have speculated that early intervention could be preferable. On the other hand, in many centres worldwide patients are primarily treated by a simple chest tube with or without pleural fibrinolysis. In case of failure of simple drainage, but this means several "precious" days later, a more invasive procedure is needed. At that moment tight pleural septa have formed, and often a surgical VATS or thoracotomy in general anaesthesia becomes necessary. Therefore, this pivotal study could lead to changes in the management of patients with pleural empyema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical thoracoscopy | Experimental | Procedure: Medical thoracoscopy |
| Simple chest tube drainage | Active comparator | Procedure: Simple chest tube drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Septated pleural effusion (ultrasonography) in the context of a lower respiratory tract infection
- Frank pleural empyema (pus)
Key exclusion criteria (5 listed)
- Fibrothorax
- Tuberculous empyema
- Medical thoracoscopy cannot be performed within 24 hours
- Pregnancy
- Inability to give informed consent
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 |
|---|---|---|
| Medical thoracoscopy | Procedure or surgery | Medical thoracoscopy |
| Simple chest tube drainage | Procedure or surgery | Simple chest tube drainage |
Primary outcome
Medical cure without secondary Intervention
Death
7 secondary outcomes
Duration of hospital stay
Radiological outcome
Duration of drainage
Total amount of drainage fluid
Estimated cost
Adverse events
Pleural pharmacokinetics of linezolid
Results and safety
The study was stopped early (reason given: insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
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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.
Martin H Brutsche, MD, Prof. principal investigator
Pneumology, Kantonsspital St. Gallen
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medical thoracoscopy and Simple chest tube drainage in people with Complicated Parapneumonic Effusion and Pleural Empyema, run by University Hospital, Basel, Switzerland at 5 sites in 3 countries.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Greece, Switzerland. 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 was stopped early (reason given: insufficient enrollment). Results are not available in the source record.
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?
Medical cure without secondary Intervention. The study lists 2 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 24 May 2016.