Tuberculous PleurisyNCT00338793
Corticosteroids in the Treatment of Tuberculous Pleurisy
A study testing prednisolone in people with Tuberculous Pleurisy, run by Guangxi Medical University at 1 site in China.
Trial summary
Tuberculous pleurisy is associated with inflammation and fibrosis. Adjunctive corticosteroids are used for tuberculous pleurisy because their anti-inflammatory effect is thought to minimise pleural reactivity and thereby reduce residual pleural thickening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculous Pleurisy
- What is being tested?
- prednisolone
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- Jul 2006to Aug 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent;
- Presented with clinical features suggesting pleural tuberculosis;
- Had not previously received treatment or prophylaxis for tuberculosis;
- Had not recently received treatment with glucocorticoids;
- Were not pregnant or breast-feeding.
Who cannot join
- Failed to complete the screening procedures;
- Were seropositive for HIV
- Tuberculous meningitis;
- Had risk factors for serious steroid-related adverse events (a history of diabetes or positive urine glucose, a history or clinical finding of hypertension, or a history of peptic ulcer disease or mental illness);
- Standard doses of antituberculosis drugs could not be used (as in participants with concurrent liver disease)
- Psychiatric illness;
- Alcoholism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Corticosteroids for Treatment of Patients With Tuberculous Pleurisy
Tuberculous pleurisy is associated with inflammation and fibrosis. Adjunctive corticosteroids are used for tuberculous pleurisy because their anti-inflammatory effect is thought to minimise pleural reactivity and thereby reduce residual pleural thickening. The purpose is to evaluate the efficacy and safety of oral prednisolone for treatment of adult patients with tuberculous pleurisy.
- Conditions
- Tuberculous Pleurisy
- Being tested
- prednisolone
- Keywords
- Tuberculosis;, Pleural effusion;, Corticosteroids.
- Medical subject headings
- Tuberculosis, Pleural, Tuberculosis, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisoloneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Presence of pleural thickening
Pulmonary function at completion of treatment
Adverse drug effects
Secondary outcomes (3)
Improvement in clinical symptoms and signs (such as pleuritic chest pain, temperature)
Reabsorption of pleural effusion
Failure rate at the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startJul 2006
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Ministry of Education, China, Bureau of Science and Technology of Guangxi Province, China
- Investigators
- Huan-Zhong Shi, MD, PhD, Study chair, Institute of Respiratory Diseases, First Affiliated Hospital, Guangxi Medical University, Nanning 530021, Guangxi, ChinaZhan-Cheng Gao, MD, PhD, Principal investigator, Department of Respiratory Diseases, People's Hospital, Peking University, Beijing, ChinaXin Zhou, MD, Principal investigator, Department of Respiratory Diseases, First Affiliated Hospital, Shanghai Jiaotong University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338793
- Sponsor's protocol ID
- Shi-TB-01
- Status last verified
- Aug 2008
- First submitted
- 19 Jun 2006
- Last updated
- 26 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Corticosteroids for Treatment of Patients With Tuberculous Pleurisy
- ClinicalTrials.gov ID
- NCT00338793
- Acronym / sponsor ID
- Shi-TB-01
- Conditions
- Tuberculous Pleurisy
- Keywords
- Tuberculosis;, Pleural effusion;, Corticosteroids.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Ministry of Education, China, Bureau of Science and Technology of Guangxi Province, China
- Study start
- Jul 2006
- Study completion
- Aug 2008 (actual)
- First posted
- 20 Jun 2006 (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 pleurisy is associated with inflammation and fibrosis. Adjunctive corticosteroids are used for tuberculous pleurisy because their anti-inflammatory effect is thought to minimise pleural reactivity and thereby reduce residual pleural thickening. The purpose is to evaluate the efficacy and safety of oral prednisolone for treatment of adult patients with tuberculous pleurisy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed written informed consent;
- Presented with clinical features suggesting pleural tuberculosis;
- Had not previously received treatment or prophylaxis for tuberculosis;
- Had not recently received treatment with glucocorticoids;
- Were not pregnant or breast-feeding.
Key exclusion criteria (7 listed)
- Failed to complete the screening procedures;
- Were seropositive for HIV
- Tuberculous meningitis;
- Had risk factors for serious steroid-related adverse events (a history of diabetes or positive urine glucose, a history or clinical finding of hypertension, or a history of peptic ulcer disease or mental illness);
- Standard doses of antituberculosis drugs could not be used (as in participants with concurrent liver disease)
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 |
|---|---|---|
| prednisolone | Drug | – |
Primary outcome
Death
Presence of pleural thickening
Pulmonary function at completion of treatment
Adverse drug effects
3 secondary outcomes
Improvement in clinical symptoms and signs (such as pleuritic chest pain, temperature)
Reabsorption of pleural effusion
Failure rate at the end of treatment
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 26 Aug 2008.
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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.
Huan-Zhong Shi, MD, PhD study chair
Institute of Respiratory Diseases, First Affiliated Hospital, Guangxi Medical University, Nanning 530021, Guangxi, China
Zhan-Cheng Gao, MD, PhD principal investigator
Department of Respiratory Diseases, People's Hospital, Peking University, Beijing, China
Xin Zhou, MD principal investigator
Department of Respiratory Diseases, First Affiliated Hospital, Shanghai Jiaotong University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prednisolone in people with Tuberculous Pleurisy, run by Guangxi Medical University at 1 site in China.
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 5 inclusion and 7 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 26 Aug 2008. 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 China. 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?
Death. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2008.