Corticosteroids in the Treatment of Tuberculous Pleurisy

Sponsor

Guangxi Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT00338793

Collaborator

National Natural Science Foundation of China (Other), Ministry of Education, China (Other), Bureau of Science and Technology of Guangxi Province, China (Other)

1,500

Enrollment

Location

Duration (Months)

59.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tuberculous Pleurisy	Drug: prednisolone	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2006

Actual Study Completion Date :

Aug 1, 2008

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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