Corticosteroids in the Treatment of Tuberculous Pleurisy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-08-31

Brief Summary

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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

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Conditions

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Tuberculous Pleurisy

Keywords

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Tuberculosis; Pleural effusion; Corticosteroids.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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prednisolone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Huan-Zhong Shi, MD, PhD

Role: STUDY_CHAIR

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

Zhan-Cheng Gao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Respiratory Diseases, People's Hospital, Peking University, Beijing, China

Xin Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Respiratory Diseases, First Affiliated Hospital, Shanghai Jiaotong University, Shanghai, China

Locations

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Huan-Zhong Shi

Nanning, Guangxi, China

Site Status

Countries

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China

Other Identifiers

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Shi-TB-01

Identifier Type: -

Identifier Source: org_study_id