Corticosteroids in the Treatment of Tuberculous Pleurisy

A Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Corticosteroids for Treatment of Patients With Tuberculous Pleurisy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00338793

Enrollment

1500

Registered

2006-06-20

Start date

2006-07-31

Completion date

2008-08-31

Last updated

2008-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculous Pleurisy

Keywords

Tuberculosis;, Pleural effusion;, Corticosteroids.

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.

Interventions

DRUGprednisolone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Death	—
Presence of pleural thickening	—
Pulmonary function at completion of treatment	—
Adverse drug effects	—

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026