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Completed

NCT Number: NCT00338793

Corticosteroids in the Treatment of Tuberculous Pleurisy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huan-Zhong Shi

Nanning, Guangxi, 530021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prednisolone

Drug

Primary outcomes

  1. Death

  2. Presence of pleural thickening

  3. Pulmonary function at completion of treatment

  4. Adverse drug effects

Secondary outcomes

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

  2. Reabsorption of pleural effusion

  3. Failure rate at the end of treatment

Sponsors and collaborators

Lead sponsor

Guangxi Medical University

Other

Collaborators

  • Bureau of Science and Technology of Guangxi Province, China
  • Ministry of Education, China
  • National Natural Science Foundation of China

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2008
First posted
Jun 20, 2006
Registry last updated
Aug 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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