NCT00234208

Brief 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. 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_3

Geographic Reach
3 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

October 5, 2005

Last Update Submit

May 23, 2016

Conditions

Complicated Parapneumonic EffusionPleural Empyema

Keywords

Complicated parapneumonic effusionPleural empyemaInterventionMedical thoracoscopyChest tube drainage

Outcome Measures

Primary Outcomes (2)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Medical thoracoscopy

EXPERIMENTAL
Procedure: Medical thoracoscopy

Simple chest tube drainage

ACTIVE COMPARATOR
Procedure: Simple chest tube drainage

Interventions

Medical thoracoscopyPROCEDURE
Medical thoracoscopy
Simple chest tube drainagePROCEDURE
Simple chest tube drainage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Septated pleural effusion (ultrasonography) in the context of a lower respiratory tract infection
  • Frank pleural empyema (pus)

You may not qualify if:

  • Fibrothorax
  • Tuberculous empyema
  • Medical thoracoscopy cannot be performed within 24 hours
  • Pregnancy
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Pneumology, University Hospital of Alexandroupolis

Alexandroupoli, 68100, Greece

Location

Pulmonology Unit, Spedali Civili di Brescia

Brescia, 25103, Italy

Location

UO Pneumologia

Imperia, 18100, Italy

Location

Pulmonology and Thoracic Endoscopy Unit Azienda Ospedaliera di Parma

Parma, 43100, Italy

Location

Centre Valaisan de Pneumologie

Crans-Montana, CH-3963, Switzerland

Location

MeSH Terms

Conditions

Empyema, Pleural

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsEmpyemaSuppurationPleural DiseasesRespiratory Tract DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martin H Brutsche, MD, Prof.

    Pneumology, Kantonsspital St. Gallen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2005

First Posted

October 6, 2005

Study Start

October 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

May 24, 2016

Record last verified: 2016-05

Locations

IT(3)GR(1)CH(1)