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CTRI Number  CTRI/2023/10/058524 [Registered on: 11/10/2023] Trial Registered Prospectively
Last Modified On: 04/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Non Tubercular Mycobacteria Disease at AVBRH: A Clinical Overview 
Scientific Title of Study   Clinical profile of Nontuberculous mycobacterial (NTM) disease in patients at AVBRH 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jay Bhanushali  
Designation  Junior Resident  
Affiliation  Jawaharlal Nehru Medical College Sawangi Meghe Wardha  
Address  Department of Respiratory Medicine,Jawaharlal Nehru Medical College,Sawangi meghe, DMIHER,wardha 442001 MAHARASHTRA India

Wardha
MAHARASHTRA
442001
India 
Phone  9769044141  
Fax    
Email  jay.bhanushali94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Babaji Ghewade 
Designation  Head of Unit 
Affiliation  Jawaharlal Nehru Medical College Sawangi Meghe Wardha  
Address  Department of Respiratory Medicine,Jawaharlal Nehru Medical College,Sawangi meghe, DMIHER,wardha 442001 MAHARASHTRA India

Wardha
MAHARASHTRA
442001
India 
Phone  9822342770  
Fax    
Email  crownbabaji@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jay Bhanushali  
Designation  Junior Resident  
Affiliation  Jawaharlal Nehru Medical College Sawangi Meghe Wardha  
Address  Department of Respiratory Medicine,Jawaharlal Nehru Medical College,Sawangi meghe, DMIHER,wardha 442001 MAHARASHTRA India

Wardha
MAHARASHTRA
442001
India 
Phone  9769044141  
Fax    
Email  jay.bhanushali94@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College Sawangi Meghe Wardha  
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College Sawangi Meghe  
Address  DMIHER, Sawangi Meghe Wardha Maharashtra  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jay Bhanushali   Jawaharlal Nehru Medical College   OPD no.7 ,Department of Respiratory Medicine, AVBRH Hospital, Sawangi Meghe Wardha 442001 Maharashtra India
Wardha
MAHARASHTRA 
9769044141

jay.bhanushali94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, DMIMS (DU)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A159||Respiratory tuberculosis unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  i) CBNAAT postive TB patients
ii) Patients declining written informed consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
Species identification, & relevant comorbidities & determination of high risk factors   52 weeks 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  NIL

  2. What additional supporting information will be shared?
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response (Others) -  NIL
  3. Who will be able to view these files?
    Response (Others) -  NIL

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jay.bhanushali94@gmail.com].

  6. For how long will this data be available start date provided 01-08-2022 and end date provided 30-11-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
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 patients’ 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/µl, 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)-γ 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.
 
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