Corticosteroids in the Treatment of Tuberculous Pleurisy

Tuberculous Pleurisy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338793
• Other study ID #: Shi-TB-01
• Status: Completed
• Phase: N/A
• First received: June 19, 2006
• Last updated: August 25, 2008
• Start date: July 2006
• Est. completion date: August 2008

Study information

• Verified date: August 2008
• Source: Guangxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pleurisy
• Tuberculosis
• Tuberculosis, Pleural
• Tuberculous Pleurisy

Intervention

Drug:
• prednisolone

Locations

Country	Name	City	State
China	Huan-Zhong Shi	Nanning	Guangxi

Sponsors (4)

Lead Sponsor	Collaborator
Guangxi Medical University	Bureau of Science and Technology of Guangxi Province, China, Ministry of Education, China, National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death
Primary	Presence of pleural thickening
Primary	Pulmonary function at completion of treatment
Primary	Adverse drug effects
Secondary	Improvement in clinical symptoms and signs (such as pleuritic chest pain, temperature)
Secondary	Reabsorption of pleural effusion
Secondary	Failure rate at the end of treatment