Corticosteroids in the Treatment of Tuberculous Pleurisy

NCT00338793 | Completed DMC

• 1 other identifier: Shi-TB-01
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculous Pleurisy

Keywords

Tuberculosis;; Pleural effusion;; Corticosteroids.

Outcome Measures

Primary Outcomes (4)

• Death

• Presence of pleural thickening

• Pulmonary function at completion of treatment

• Adverse drug effects

Secondary Outcomes (3)

• Improvement in clinical symptoms and signs (such as pleuritic chest pain, temperature)

• Reabsorption of pleural effusion

• Failure rate at the end of treatment

Interventions

prednisolone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangxi Medical University: lead
• National Natural Science Foundation of China: collaborator
• Ministry of Education, China: collaborator
• Bureau of Science and Technology of Guangxi Province, China: collaborator

Study Sites (1)

Huan-Zhong Shi

Nanning, Guangxi, 530021, China

Location

MeSH Terms

Conditions

Tuberculosis, Pleural; Tuberculosis; Pleural Effusion

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Tuberculosis, Extrapulmonary; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Huan-Zhong Shi, MD, PhD

  Institute of Respiratory Diseases, First Affiliated Hospital, Guangxi Medical University, Nanning 530021, Guangxi, China

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 20, 2006
• Study Start: July 1, 2006
• Study Completion: August 1, 2008
• Last Updated: August 26, 2008

Record last verified: 2008-08

Locations

CN (1)