Non Tubercular Mycobacteria Disease at AVBRH: A Clinical Overview

Not yet recruiting

Conditions: Respiratory tuberculosis unspecified,

Registration Number: CTRI/2023/10/058524

Lead Sponsor: Jawaharlal Nehru Medical College Sawangi Meghe

Brief Summary: NTM are ubiquitous organisms commonly found in the environment and have been isolated from soil, water, air, plants etc. Among the diverse group of NTM strains, around one-third has been associated with human diseases [1]. NTM, recognized as a pathogen way back in 1930s, are being isolated more frequently from patientsâ€™ samples recently. This increase in isolation may be due to an increase in the immunocompromised population and an increase in surgical procedures; but partially may be attributed to improved microbiology techniques and also increased awareness among clinicians and microbiologists. The American Thoracic society (ATS) and Infectious Disease Society of America (IDSA) have jointly published guidelines in an effort to standardize the definition of NTM infection because unlike tuberculosis, isolation of NTM in pulmonary specimens does not necessarily indicate disease [2]. Diagnosing pulmonary infection needs a combination of symptoms, radiological abnormalities and microbiological cultures in conjunction with exclusion of other possible etiologies.

According to the ATS guidelines for diagnosis, treatment and prevention of NTM [2]; pathogenesis of NTM infections is different between patients infected with HIV and patients uninfected with HIV. In HIV infected, NTM infections occurred only when the CD4 T-lymphocyte number falls below 50/Âµl, suggesting that specific bio-molecules secreted by T-cell are required for resistance against mycobacteria. However, in HIV-uninfected cases, NTM infections are associated with specific mutations in interferon (IFN)-Î³ and interleukin (IL)-12 synthesis and signalling pathways (e.g. IFN-receptor 1 [IFNR1], IFN- receptor 2 [IFNR2], IL-12 receptor 1 subunit [IL12R1], the IL-12 subunit p40 receptor 1 [IFNR1], IFN- receptor 2 [IFNR2], IL-12 receptor 1 subunit [IL12R1], the IL-12 subunit p40 [IL12p40], the signal transducer and activator of transcription 1 [STAT1], and the nuclear factor- essential modulator [NEMO] ). Exact mechanism of NTM pathogenesis has not been discovered. Various NTM species are known to have varying virulence capabilities.

Recently, there has been a rapid increase in the isolation of NTM predominantly due to an increase in the immunocompromised population and also due to the availability of more accurate identification techniques and greater disease awareness. Diagnosis of NTM infections is challenging due to overlap of clinical manifestations of NTM diseases with TB [3]. Over past few decades the diagnosis of NTM infections was based on the clinical features, associated risk factors and antibiogram patterns [4, 5]. Diagnosis and drug susceptibility testing of NTM is of great significance in the management owing to the fact that NTM are relatively resistant to most of the first- and second-line drugs used for the treatment of TB. This property, sometimes leads to misidentification of NTM as MDR-TB [6]. Recent epidemiological data suggest a worldwide increase in both incidence as well as prevalence of NTM disease. NTM are increasingly recognized to cause both pulmonary and extra-pulmonary diseases. Evidence also points towards a change in the epidemiology of NTM diseases and its occurrence both in immunocompetent as well as immunocompromized populations [7]. Pre-existing lung diseases and age more than 50 years are known risk factors, and reports from non European countries have documented its occurrence even in non-smoker females without pre-existing diseases.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 25

Inclusion Criteria

i)Patients >12 years of age of either gender and irrespective of their HIV status b)Patients suspected to have pulmonary and extrapulmonary NTM disease c)Clinical: For pulmonary NTM disease patients suspected to have pulmonary symptoms, nodular or cavitary opacities on chest radiograph or an HRCT scan that shows multifocal bronchiectasis with multiple small nodules.
disseminated disease including skin involvement; following organ transplantation).
iv)Microbiological: Patients with positive culture results from at least two separate expectorated sputum samples.
v)Drug-resistant TB (DR-TB) suspects.

Exclusion Criteria

i)CBNAAT postive TB patients ii)Patients declining written informed consent.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence and Incidence rates, demographic factors, various clinical presentation, microbiological characteristics, antibiotic susceptibility, associated comorbidities, various treatment approaches, mortality, infectious control, long term follow up	at baseline, 12 weeks and 52 weeks

Secondary Outcome Measures

Name	Time	Method
Species identification, & relevant comorbidities & determination of high risk factors	52 weeks

Trial Locations

Locations (1): Jawaharlal Nehru Medical College
🇮🇳
Wardha, MAHARASHTRA, India
Jawaharlal Nehru Medical College
🇮🇳Wardha, MAHARASHTRA, India
Dr Jay Bhanushali
Principal investigator
9769044141
jay.bhanushali94@gmail.com