Tuberculous PleurisyNCT00524147
Drainage of Tuberculous Pleural Effusions
A study testing Pigtail drainage in people with Tuberculous Pleurisy, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
Tuberculous (TB) pleurisy can cause clinical symptoms and pleural fibrosis with resultant residual pleural thickening (RPT). Therapeutic thoracentesis or initial complete drainage in addition to anti-TB drugs have been tried to rapidly relieve dyspnea caused by effusion and to decrease the occurrence of RPT. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tuberculous Pleurisy
- What is being tested?
- Pigtail drainage
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2003to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of tuberculous pleurisy
Who cannot join
- History of invasive procedures directed into the pleural cavity
- Recent severe trauma, hemorrhage, or stroke; bleeding disorder or anticoagulant therapy
- Use of streptokinase in the previous 2 years
- Lack of clinical symptoms caused by effusions
Trial locations and contacts
1 site in 1 country.
About this study
Tuberculous (TB) pleurisy can cause clinical symptoms and pleural fibrosis with resultant residual pleural thickening (RPT). Therapeutic thoracentesis or initial complete drainage in addition to anti-TB drugs have been tried to rapidly relieve dyspnea caused by effusion and to decrease the occurrence of RPT. However, contradictory results are reported without clear reasons. The researchers' hypothesis is that, in addition to anti-TB medications, early effective evacuation of inflammatory exudates with or without fibrinolytic agents may hasten resolution of pleural effusion, reduce the occurrence of RPT and finally improve long-term functional outcome in patients with TB pleurisy.
- Conditions
- Tuberculous Pleurisy
- Being tested
- Pigtail drainage
- Keywords
- loculated pleural effusion, pigtail drainage, pleural effusion, pleural thickening, tuberculosis
- Medical subject headings
- Tuberculosis, Pleural, Pleural Effusion, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pigtail drainageProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest radiography, daily monitoring of the volume of fluid drained, the time needed for resolution of fever and dyspnea, and total amounts of fluid drained, and the length of chest drainage and hospitalization
Measured: baseline, daily after treatment within admission
Secondary outcomes (1)
Chest radiography and pulmonary function testing with spirometry
Measured: At discharge and at 2, 4, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startOct 2003
- Primary completionOct 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tuberculous PleurisyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chi-Li Chung, MD, Principal investigator, Department of Internal Medicine, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524147
- Sponsor's protocol ID
- TMU92-AE1-B36
- Status last verified
- Dec 2010
- First submitted
- 31 Aug 2007
- Last updated
- 30 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Chung CL, Chen CH, Yeh CY, Sheu JR, Chang SC. Early effective drainage in the treatment of loculated tuberculous pleurisy. Eur Respir J. 2008 Jun;31(6):1261-7. doi: 10.1183/09031936.00122207. Epub 2008 Jan 23.
PubMed 18216051
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drainage of Tuberculous Pleural Effusions
- ClinicalTrials.gov ID
- NCT00524147
- Acronym / sponsor ID
- TMU92-AE1-B36
- Conditions
- Tuberculous Pleurisy
- Keywords
- loculated pleural effusion, pigtail drainage, pleural effusion, pleural thickening, tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 3 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tuberculous (TB) pleurisy can cause clinical symptoms and pleural fibrosis with resultant residual pleural thickening (RPT). Therapeutic thoracentesis or initial complete drainage in addition to anti-TB drugs have been tried to rapidly relieve dyspnea caused by effusion and to decrease the occurrence of RPT. However, contradictory results are reported without clear reasons. The researchers' hypothesis is that, in addition to anti-TB medications, early effective evacuation of inflammatory exudates with or without fibrinolytic agents may hasten resolution of pleural effusion, reduce the occurrence of RPT and finally improve long-term functional outcome in patients with TB pleurisy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of tuberculous pleurisy
Key exclusion criteria (4 listed)
- History of invasive procedures directed into the pleural cavity
- Recent severe trauma, hemorrhage, or stroke; bleeding disorder or anticoagulant therapy
- Use of streptokinase in the previous 2 years
- Lack of clinical symptoms caused by effusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pigtail drainage | Procedure or surgery | – |
Primary outcome
Chest radiography, daily monitoring of the volume of fluid drained, the time needed for resolution of fever and dyspnea, and total amounts of fluid drained, and the length of chest drainage and hospitalization
Time frame: baseline, daily after treatment within admission
1 secondary outcome
Chest radiography and pulmonary function testing with spirometry
Time frame: At discharge and at 2, 4, 6, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2010.
- Derived from this study: PubMed 18216051Chung CL, Chen CH, Yeh CY, Sheu JR, Chang SC. Early effective drainage in the treatment of loculated tuberculous pleurisy. Eur Respir J. 2008 Jun;31(6):1261-7. doi: 10.1183/09031936.00122207. Epub 2008 Jan 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi-Li Chung, MD principal investigator
Department of Internal Medicine, Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pigtail drainage in people with Tuberculous Pleurisy, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest radiography, daily monitoring of the volume of fluid drained, the time needed for resolution of fever and dyspnea, and total amounts of fluid drained, and the length of chest drainage and hospitalization (time frame: baseline, daily after treatment within admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00524147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2010.