Corticosteroids in the Treatment of Tuberculous Pleurisy
Not Applicable
Completed
- Conditions
- Tuberculous Pleurisy
- Registration Number
- NCT00338793
- Lead Sponsor
- Guangxi Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1500
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Death Presence of pleural thickening Pulmonary function at completion of treatment Adverse drug effects
- Secondary Outcome Measures
Name Time Method Improvement in clinical symptoms and signs (such as pleuritic chest pain, temperature) Reabsorption of pleural effusion Failure rate at the end of treatment
Trial Locations
- Locations (1)
Huan-Zhong Shi
🇨🇳Nanning, Guangxi, China