Corticosteroids in the Treatment of Tuberculous Pleurisy

August 25, 2008 updated by: Guangxi Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Huan-Zhong Shi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Death
Presence of pleural thickening
Pulmonary function at completion of treatment
Adverse drug effects

Secondary Outcome Measures

Outcome Measure
Improvement in clinical symptoms and signs (such as pleuritic chest pain, temperature)
Reabsorption of pleural effusion
Failure rate at the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangxi Medical University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 19, 2006

First Posted (Estimate)

June 20, 2006

Study Record Updates

Last Update Posted (Estimate)

August 26, 2008

Last Update Submitted That Met QC Criteria

August 25, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shi-TB-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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