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Efficacy of Antituberculous Therapy in Management of Sarcoidosis

Information source: Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sarcoidosis; Tuberculosis

Intervention: Antituberculous therapy along with steroids (Drug)

Phase: N/A

Status: Completed

Sponsored by: Postgraduate Institute of Medical Education and Research

Official(s) and/or principal investigator(s):
Dheeraj Gupta, Principal Investigator, Affiliation: PGIMER, Chandigarh

Summary

From the time sarcoidosis has been described, there has always been a belief that the disease is in some way related to tuberculosis. If indeed tuberculosis is a causal factor in sarcoidosis, then the hypothesis can be further reinforced, if anti-tubercular therapy (ATT) is useful in treatment of sarcoidosis. Very few trials have been conducted in the past but the results of these trials have been discouraging. These trials were generally small studies and limited by time bias and used older regimens based on isoniazid, amino-salicylic acid and streptomycin. In our experience nearly one third of patients who are finally diagnosed to have sarcoidosis, have received ATT for variable length of time, but its impact of final outcome of sarcoidosis has not been studied. The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of Rifampicin and Isoniazid along with prednisolone compared to prednisolone alone in treatment of Sarcoidosis.

Clinical Details

Official title: Rifampicin and Isoniazid Along With Prednisolone Compared to Prednisolone Alone in Treatment of Sarcoidosis: a Pilot Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Remission rates

Secondary outcome:

Relapse rates in the two groups

Treatment related adverse effects in the two groups.

Detailed description: Sarcoidosis has evolved from the position of a disease of relative obscurity in the tropics, towards an increasing recognition and reporting from India and around. From the time sarcoidosis has been described, there has always been a belief that the disease is in some way related to tuberculosis. However, the inability to identify mycobacteria by histologic staining or culture from pathologic tissues continues to be one of the strongest arguments against a potential role for mycobacteria. Of late, molecular analysis (such as polymerase chain reaction [PCR] techniques) for nucleic acids of the putative agents serves as an alternative method for isolating fastidious organisms. A recent meta-analysis suggested a 30% prevalence rate of mycobacterial DNA in sarcoid samples but the individual studies reported detection rates from 0-50%. Moreover, most of these studies were published from countries with low prevalence for tuberculosis. If indeed mycobacteria are etiologically linked to sarcoidosis then the detection rates for mycobacterial DNA in sarcoid samples would be higher in countries with high prevalence of TB. In a recent prospective case-control study aimed at detection of mycobacterial DNA in patients with sarcoidosis from India, reinforced the hypothesis by showing mycobacterial DNA with PCR for 65 kDa protein gene in 48% of samples (BAL or biopsy) from freshly diagnosed patients of sarcoidosis. There are numerous factors that favor mycobacteria being a trigger for sarcoidosis. These include histopathological appearances of the granulomas 15, reports of mycobacterial disease either existing coincidentally, succeeding or antedating sarcoidosis and the finding of mycobacteria in occasional granulomas of sarcoidosis. Passage experiments have also suggested that mycobacteria with characteristics of M. tuberculosis may be the incriminating agent. Recent studies on humoral immunity to mycobacterial antigens from sarcoidosis patients have renewed interest in a potential of mycobacteria in sarcoidosis. It has been shown that mycobacterial ESAT-6 and katG are recognized by sarcoidosis CD4+ T cells when presented by known sarcoidosis susceptibility allele, DRB1*1101. It is possible that the presence of mycobacterial infection or BCG vaccination in genetically predisposed host may be involved in the development of autoimmunity. It has also been suggested that the organism might exist in a cell wall deficient L-form and may be difficult to isolate. This possible link not only has implications in the differential diagnosis of the two common conditions, it may also have some therapeutic implications. Reactivation of tuberculosis after cortico-steroid treatment is instituted for sarcoidosis is a genuine concern, given the high prevalence of latent infection in our country. If indeed tuberculosis is a causal factor in sarcoidosis, then the hypothesis can be further reinforced, if anti-tubercular therapy (ATT) is useful in treatment of sarcoidosis. Very few trials have been conducted in the past but the results of these trials have been discouraging. These trials were generally small studies and limited by time bias and used older regimens based on isoniazid, amino-salicylic acid and streptomycin. In our experience nearly one third of patients who are finally diagnosed to have sarcoidosis, have received ATT for variable length of time, but its impact of final outcome of sarcoidosis has not been studied. The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of Rifampicin and Isoniazid along with prednisolone compared to prednisolone alone in treatment of Sarcoidosis.

Eligibility

Minimum age: 15 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: newly diagnosed sarcoidosis defined by presence of all of the following criteria: 1. Presence with clinical features of pulmonary (dyspnea, dry cough, chest pain, fever, fatigue or crackles) or extra pulmonary organ (lymph nodes, liver, spleen, skin, eyes, heart, etc.) involvement and consistent radiological involvement and 2. Compact non-caseating granulomas on trans-bronchial biopsy which are tissue AFB smear-negative Exclusion Criteria: Patients who have received glucocorticoid treatment before initial evaluation by us, or with presence of concomitant other cardio pulmonary disease will be excluded.

Locations and Contacts

Deaprtment of Pulmonary Medicine, PGIMER, Chandigarh 160012, India
Additional Information

Starting date: January 2009
Last updated: May 13, 2013

Page last updated: August 23, 2015

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