NCT00520221

Brief Summary

The optimal initial management of primary spontaneous pneumothorax (PSP) remains controversial. This study was conducted to evaluate the safety and efficacy of additional minocycline pleurodesis after successful aspiration of the first episode of PSP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2004

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
Last Updated

August 23, 2007

Status Verified

January 1, 2004

First QC Date

August 21, 2007

Last Update Submit

August 22, 2007

Conditions

Pneumothorax

Keywords

minocyclinepleurodesisaspirationpneumothoraxPrimary spontaneous pneumothoraxFirst attackSuccessful aspiration

Study Arms (1)

2

Minocycline group: 300 mg of minocycline hydrochloride was instilled into the pleural space through the catheter. Control group consisted of 33 patients who had successful simple aspiration alone between January 2004 and December 2005.

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Primary spontaneous pneumothorax patients who underwent manual aspiration as their initial treatment were selected.

You may not qualify if:

  • Patients with a previous history of spontaneous pneumothorax, \>50 years of age, or with preexisting pulmonary diseases were excluded. Patients with unsuccessful aspiration requiring further chest tube insertion or thoracoscopic operation were also excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Pneumothoraxcyclopia sequence

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Yung-Chie Lee, MD, PhD

    Department of Surgery, National Taiwan University Hospital, Taiwan

    STUDY CHAIR

  • Jin-Shing Chen, MD, PhD

    Department of Surgery, National Taiwan University Hospital, Taiwan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 23, 2007

Study Start

January 1, 2004

Study Completion

July 1, 2007

Last Updated

August 23, 2007

Record last verified: 2004-01

Locations

TW(1)