Back to resultsCorticosteroids in the Treatment of Tuberculous Pleurisy
Primary Purpose
Tuberculous Pleurisy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Tuberculous Pleurisy focused on measuring Tuberculosis;, Pleural effusion;, Corticosteroids.
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Huan-Zhong Shi
Outcomes
Primary Outcome Measures
Death
Presence of pleural thickening
Pulmonary function at completion of treatment
Adverse drug effects
Secondary Outcome Measures
Improvement in clinical symptoms and signs (such as pleuritic chest pain, temperature)
Reabsorption of pleural effusion
Failure rate at the end of treatment
Full Information
NCT ID
NCT00338793
First Posted
June 19, 2006
Last Updated
August 25, 2008
Sponsor
Guangxi Medical University
Collaborators
National Natural Science Foundation of China, Ministry of Education, China, Bureau of Science and Technology of Guangxi Province, China
1. Study Identification
Unique Protocol Identification Number
NCT00338793
Brief Title
Corticosteroids in the Treatment of Tuberculous Pleurisy
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Guangxi Medical University
Collaborators
National Natural Science Foundation of China, Ministry of Education, China, Bureau of Science and Technology of Guangxi Province, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. The purpose is to evaluate the efficacy and safety of oral prednisolone for treatment of adult patients with tuberculous pleurisy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculous Pleurisy
Keywords
Tuberculosis;, Pleural effusion;, Corticosteroids.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
prednisolone
Primary Outcome Measure Information:
Title
Death
Title
Presence of pleural thickening
Title
Pulmonary function at completion of treatment
Title
Adverse drug effects
Secondary Outcome Measure Information:
Title
Improvement in clinical symptoms and signs (such as pleuritic chest pain, temperature)
Title
Reabsorption of pleural effusion
Title
Failure rate at the end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huan-Zhong Shi, MD, PhD
Organizational Affiliation
Institute of Respiratory Diseases, First Affiliated Hospital, Guangxi Medical University, Nanning 530021, Guangxi, China
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zhan-Cheng Gao, MD, PhD
Organizational Affiliation
Department of Respiratory Diseases, People's Hospital, Peking University, Beijing, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xin Zhou, MD
Organizational Affiliation
Department of Respiratory Diseases, First Affiliated Hospital, Shanghai Jiaotong University, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huan-Zhong Shi
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
12. IPD Sharing Statement
Learn more about this trial
Corticosteroids in the Treatment of Tuberculous Pleurisy
We'll reach out to this number within 24 hrs