Corticosteroids in the Treatment of Tuberculous Pleurisy

This study has been completed.

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
Information provided by:	Guangxi Medical University
ClinicalTrials.gov Identifier:	NCT00338793

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

MedlinePlus related topics: Tuberculosis

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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

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

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

Keywords provided by Guangxi Medical University:

Tuberculosis;
Pleural effusion;
Corticosteroids.

Study placed in the following topic categories:

Bacterial Infections
Pleurisy
Methylprednisolone
Pleural Diseases
Methylprednisolone acetate
Prednisolone acetate
Pleural Effusion
Gram-Positive Bacterial Infections

Respiratory Tract Diseases
Respiratory Tract Infections
Prednisolone
Mycobacterium Infections
Tuberculosis
Tuberculosis, Pleural
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions
Actinomycetales Infections

ClinicalTrials.gov processed this record on February 05, 2009