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
|
|
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
|
|
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
- What data in particular will be shared?
Response (Others) - NIL
- What additional supporting information will be shared?
Response - Informed Consent Form Response - Clinical Study Report Response (Others) - NIL
- Who will be able to view these files?
Response (Others) - NIL
- For what types of analyses will this data be available?
Response (Others) - NIL
- By what mechanism will data be made available?
Response - Proposals should be directed to [jay.bhanushali94@gmail.com].
- 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.
- 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. |