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Intrapleural Minocycline After Aspiration of Spontaneous Pneumothorax

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00839553
First Posted: February 9, 2009
Last Update Posted: February 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Taiwan University Hospital
Department of Health
Information provided by:
Far Eastern Memorial Hospital
  Purpose

The estimated recurrence rate of primary spontaneous pneumothorax is 23-50% after the first episode, and the optimal treatment remains unknown. In the recently published British Thoracic Society (BTS) guidelines, simple aspiration is recommended as first line treatment for all primary pneumothoraces requiring intervention. However, the 1 year recurrence rate of this procedure was as high as 25-30%, making it inappropriate as a standard of care.

Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way to shorten the duration of air leaks and reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical patients. Many chemical irritants (tetracycline, talc, and minocycline) have been used to decrease the rate of recurrence in spontaneous pneumothorax. Tetracycline, which was the most commonly used irritant, is no longer available. Talc insufflation of the pleural cavity is safe and effective for primary spontaneous pneumothorax. However, it should be applied either with surgical or medical thoracoscopy. Minocycline, a derivative of tetracycline, is as effective as tetracycline in inducing pleural fibrosis in rabbits. In the previous studies, we have shown that additional minocycline pleurodesis is a safe and convenient procedure to decrease the rates of ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax. In the present study, additional minocycline pleurodesis will be randomly administered in patients with first episode of primary spontaneous pneumothorax after simple aspiration. The primary goal is to test if intrapleural minocycline can reduce the rate of recurrence. The secondary goals are to evaluate the safety profile, short-term results, and long-term effects of minocycline pleurodesis after simple aspiration. The sites of study include National Taiwan University Hospital and Far Eastern Memorial Hospital. A total of 300 patients (150 patients in each arm) will be included for this study.


Condition Intervention
Pneumothorax Procedure: Intrapleural Minocycline application

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Intrapleural Minocycline After Manual Aspiration for the Prevention of Primary Spontaneous Pneumothorax. A Phase III Multicenter Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • Recurrence rate

Estimated Enrollment: 100
Study Start Date: April 2007
Estimated Study Completion Date: April 2009
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 15-50years old
  2. primary pneumothorax first attack
  3. viceral pleura to chest wall more then 2 cm on CXR

Exclusion Criteria:

  1. the lungs unable to expad fully after aspiration
  2. continuous leakage of air through chest tubes
  3. status complicated with hemothorax
  4. status post previous chest surgery or pleurodesis
  5. patient unwilling to accept the trial
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839553


Contacts
Contact: Kuang-Chau Tsai, Master 886-2-89667000 ext 1125 hikali@mail.femh.org.tw

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
Pan-Chiao, Taipei county, Taiwan
Contact: Kuang-Chau Tsai, Master    886-2-89667000 ext 1125    hikali@mail.femh.org.tw   
Sponsors and Collaborators
Far Eastern Memorial Hospital
National Taiwan University Hospital
Department of Health
Investigators
Study Chair: YC Lee, PhD National Taiwan University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00839553     History of Changes
Other Study ID Numbers: 95042
First Submitted: February 6, 2009
First Posted: February 9, 2009
Last Update Posted: February 9, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents