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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
History of Changes
  Purpose

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 Intervention
Tuberculous Pleurisy
 Drug: prednisolone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guangxi Medical University:

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

Estimated Enrollment: 1500
Study Start Date: July 2006
Study Completion Date: August 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00338793     History of Changes
Other Study ID Numbers: Shi-TB-01
Study First Received: June 19, 2006
Last Updated: August 25, 2008
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Pleurisy
Tuberculosis
Tuberculosis, Pleural
Pleural Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
 Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013