Intrapleural Minocycline After Aspiration of Spontaneous Pneumothorax

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Far Eastern Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Taiwan University Hospital
Department of Health
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00839553
First received: February 6, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00839553     History of Changes
Other Study ID Numbers: 95042
Study First Received: February 6, 2009
Last Updated: February 6, 2009
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on October 23, 2014