Corticosteroids in the Treatment of Tuberculous Pleurisy

Guangxi Medical University

Status

Completed

Conditions

Tuberculous Pleurisy

Treatments

Drug: prednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT00338793

Shi-TB-01

Details and patient eligibility

About

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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.