Infectious Pleural EffusionVIDMEDNCT01994499
Randomized Study Comparing Pleural Drainage by Videothoracoscopy to Medical Drainage in Infectious Pleural Effusion
A study testing Videothoracoscopy drainage and Medical drainage in people with Infectious Pleural Effusion, run by University Hospital, Rouen at 3 sites in France.
Trial summary
Infectious pleural effusion is a classic complication of pneumonia and often require pleural drainage. There is no consensus between surgical drainage and medical drainage indication in first intention to treat an empyema. Usually surgery is proposed in second intention after failure of medical drainage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Pleural Effusion
- What is being tested?
- Videothoracoscopy drainage and Medical drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesFrance
- Study dates
- 24 Jan 2014to 12 Jul 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Infectious pleural effusion diagnosed by pleural punction with biologic features of infection: C Reactive Protein level >5 mg/L, White cells counts > 10000 G/L, Temperature >38°c, effusion with a ph<7,2 or presence of polynuclear, and radiologic features of effusion requiring drainage (>1/5 thoracic volume)
Who cannot join
- prior thoracic surgery, past history of pleural effusion
- compressive effusion which should be treated in emergency
- Pregnancy
- No acceptance of the protocol by the informed patient
Trial locations and contacts
3 sites in 1 country.
France3 sites
University Hospital
Amiens, 80000
University Hospital
Caen, 14000
UH Rouen
Rouen
About this study
Infectious pleural effusion is a classic complication of pneumonia and often require pleural drainage.
There is no consensus between surgical drainage and medical drainage indication in first intention to treat an empyema.
Read more
Usually surgery is proposed in second intention after failure of medical drainage.
Videothoracoscopy is well accepted in diagnosis and treatment of pleural pathologies. The morbidity of this approach is very low with good results and become the gold standard in different pleural diseases. The medical drainage can be also very efficient but its results depends of the evolution of the pleural effusion. The rate of failure is estimated around 25%.
Then, the aim of our study is to compare surgical drainage and medical drainage in first intention. The first end-point will be the hospital stay (day). Hospital discharge will be strict, following different objective criteria of healing allowing comparison between these two approaches of drainage.
To answer this question we will randomized 50 patients in 2 years with a multicenter recruitment.
- Conditions
- Infectious Pleural Effusion
- Being tested
- Videothoracoscopy drainage, Medical drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videothoracoscopy drainageDevice
videothoracoscopy drainage of pleural effusion
Medical drainageDrug
Medical pleural drainage
| Study group | Role | What they receive |
|---|---|---|
| videothoracoscopy drainage | Experimental | videothoracoscopy drainage of pleural effusion Receives: Device: Videothoracoscopy drainage |
| Medical pleural drainage | Active comparator | Medical drainage Receives: Drug: Medical drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Stay in days
Measured: patients will be followed for the duration of the hopital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study start24 Jan 2014
- Primary completion12 Jul 2019
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious Pleural EffusionStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean-marc baste, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994499
- Sponsor's protocol ID
- 2013/009/HP
- Acronym
- VIDMED
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2013
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing Pleural Drainage by Videothoracoscopy to Medical Drainage in Infectious Pleural Effusion
- ClinicalTrials.gov ID
- NCT01994499
- Acronym / sponsor ID
- VIDMED / 2013/009/HP
- Conditions
- Infectious Pleural Effusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 24 Jan 2014 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 25 Nov 2013 (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.
Infectious pleural effusion is a classic complication of pneumonia and often require pleural drainage.
There is no consensus between surgical drainage and medical drainage indication in first intention to treat an empyema.
Usually surgery is proposed in second intention after failure of medical drainage.
Videothoracoscopy is well accepted in diagnosis and treatment of pleural pathologies. The morbidity of this approach is very low with good results and become the gold standard in different pleural diseases. The medical drainage can be also very efficient but its results depends of the evolution of the pleural effusion. The rate of failure is estimated around 25%.
Then, the aim of our study is to compare surgical drainage and medical drainage in first intention. The first end-point will be the hospital stay (day). Hospital discharge will be strict, following different objective criteria of healing allowing comparison between these two approaches of drainage.
To answer this question we will randomized 50 patients in 2 years with a multicenter recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| videothoracoscopy drainage | Experimental | Device: Videothoracoscopy drainagevideothoracoscopy drainage of pleural effusion |
| Medical pleural drainage | Active comparator | Drug: Medical drainageMedical drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Infectious pleural effusion diagnosed by pleural punction with biologic features of infection: C Reactive Protein level >5 mg/L, White cells counts > 10000 G/L, Temperature >38°c, effusion with a ph<7,2 or presence of polynuclear, and radiologic features of effusion requiring drainage (>1/5 thoracic volume)
Key exclusion criteria (4 listed)
- prior thoracic surgery, past history of pleural effusion
- compressive effusion which should be treated in emergency
- Pregnancy
- No acceptance of the protocol by the informed patient
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 |
|---|---|---|
| Videothoracoscopy drainagevideothoracoscopy drainage of pleural effusion | Device | videothoracoscopy drainage |
| Medical drainageMedical pleural drainage | Drug | Medical pleural drainage |
Primary outcome
Hospital Stay in days
Time frame: patients will be followed for the duration of the hopital stay, an expected average of 4 weeks
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 24 Nov 2023.
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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.
jean-marc baste, MD principal investigator
University Hospital, Rouen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videothoracoscopy drainage and Medical drainage in people with Infectious Pleural Effusion, run by University Hospital, Rouen at 3 sites in France.
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 1 inclusion and 4 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 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
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?
Hospital Stay in days (time frame: patients will be followed for the duration of the hopital stay, an expected average of 4 weeks). 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 Nov 2023.