Status:
UNKNOWN
Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Pneumothorax
Eligibility:
All Genders
15-40 years
Phase:
PHASE3
Brief Summary
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)...
Detailed Description
Background: Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males (1, 2). The estimated recurrence rate is 23-50% after the first episode (3). Optimal treatment of patients...
Eligibility Criteria
Inclusion
- Male or female.
- Age between 15 and 40 years old.
- First episode of spontaneous pneumothorax.
- Symptomatic (dyspnea or chest pain) or the rim of air is \> 2cm on CXR requiring simple aspiration
- Complete or nearly complete and persistent lung expansion immediately following manual aspiration
- Organ Function Requirements:
- Adequate hematological function (Hb \> 10 g/dl, ANC \> 1.5 x 109/L, platelets \> 100 x 109/L)
- Normal renal and hepatic functions: serum creatinine \< 1 x ULN, SGPT and SGOT\< 2.5 x ULN, alkaline phosphatase \< 5 x ULN
- Written inform consent
Exclusion
- With underlying pulmonary disease (asthma, chronic obstructive pulmonary disease, bronchiectasis, etc)
- With hemothorax or tension pneumothorax requiring chest tube insertion or operation
- A history of previous pneumothorax
- A history of previous ipsilateral thoracic operation
- Allergy to tetracycline or minocycline
- Pregnant or lactating patients.
- Other serious concomitant illness or medical conditions:
- Congestive heart failure or unstable angina pectoris.
- History of myocardial infarction within 1 year prior to the study entry.
- Uncontrolled hypertension or arrhythmia.
- History of significant neurologic or psychiatric disorders, including dementia or seizure.
- Active infection requiring i.v. antibiotics.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00418392
Start Date
November 1 2006
End Date
December 1 2012
Last Update
December 17 2012
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100