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Corticosteroids in the Treatment of Tuberculous Pleurisy

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ClinicalTrials.gov Identifier: NCT00338793
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : August 26, 2008
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

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.

Condition or disease Intervention/treatment Phase
Tuberculous Pleurisy Drug: prednisolone Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : July 2006
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Death
  2. Presence of pleural thickening
  3. Pulmonary function at completion of treatment
  4. Adverse drug effects

Secondary Outcome Measures :
  1. Improvement in clinical symptoms and signs (such as pleuritic chest pain, temperature)
  2. Reabsorption of pleural effusion
  3. Failure rate at the end of treatment


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338793


Locations
China, Guangxi
Huan-Zhong Shi
Nanning, Guangxi, China, 530021
Sponsors and Collaborators
Guangxi Medical University
National Natural Science Foundation of China
Ministry of Education, China
Bureau of Science and Technology of Guangxi Province, China
Investigators
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

ClinicalTrials.gov Identifier: NCT00338793     History of Changes
Other Study ID Numbers: Shi-TB-01
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: August 26, 2008
Last Verified: August 2008

Keywords provided by Guangxi Medical University:
Tuberculosis;
Pleural effusion;
Corticosteroids.

Additional relevant MeSH terms:
Tuberculosis
Pleurisy
Tuberculosis, Pleural
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pleural Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents