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Corticosteroids in the Treatment of Tuberculous Pleurisy

This study has been completed.
Sponsor:
Collaborators:
National Natural Science Foundation of China
Ministry of Education, China
Bureau of Science and Technology of Guangxi Province, China
Information provided by:
Guangxi Medical University
ClinicalTrials.gov Identifier:
NCT00338793
First received: June 19, 2006
Last updated: August 25, 2008
Last verified: August 2008

June 19, 2006
August 25, 2008
July 2006
Not Provided
  • Death
  • Presence of pleural thickening
  • Pulmonary function at completion of treatment
  • Adverse drug effects
Same as current
Complete list of historical versions of study NCT00338793 on ClinicalTrials.gov Archive Site
  • Improvement in clinical symptoms and signs (such as pleuritic chest pain, temperature)
  • Reabsorption of pleural effusion
  • Failure rate at the end of treatment
Same as current
Not Provided
Not Provided
 
Corticosteroids in the Treatment of Tuberculous Pleurisy
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Tuberculous Pleurisy
Drug: prednisolone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1500
August 2008
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00338793
Shi-TB-01
Yes
Not Provided
Guangxi Medical University
  • National Natural Science Foundation of China
  • Ministry of Education, China
  • Bureau of Science and Technology of Guangxi Province, China
Study Chair: Huan-Zhong Shi, MD, PhD Institute of Respiratory Diseases, First Affiliated Hospital, Guangxi Medical University, Nanning 530021, Guangxi, China
Principal Investigator: Zhan-Cheng Gao, MD, PhD Department of Respiratory Diseases, People's Hospital, Peking University, Beijing, China
Principal Investigator: Xin Zhou, MD Department of Respiratory Diseases, First Affiliated Hospital, Shanghai Jiaotong University, Shanghai, China
Guangxi Medical University
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP