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CTRI Number  CTRI/2025/03/083192 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 24/03/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   A study to understand Mycobacterial (TB like) infections in humans 
Scientific Title of Study   Registry for Mycobacterial infections 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vijay V Yeldandi 
Designation  Director SSRC 
Affiliation  SSRC Health Clinics 
Address  Plot No 1278 Road No 63A Jubilee hills Hyderabad
SSRC Clinics Plot # 1278, Road 63A Jubilee Hills Hyderabad 500033 Telangana
Hyderabad
TELANGANA
500033
India 
Phone  7893003300  
Fax    
Email  director@ssrchealth.care  
 
Details of Contact Person
Scientific Query  
Name  Vijay V Yeldandi 
Designation  Director SSRC 
Affiliation  SSRC Health Clinics 
Address  Plot No1278 Road No 63A Jubilee hills Hyderabad
Plot No 1278 63 A
Hyderabad
TELANGANA
500033
India 
Phone  7893003300  
Fax    
Email  director@ssrchealth.care  
 
Details of Contact Person
Public Query  
Name  Vijay V Yeldandi 
Designation  Director SSRC 
Affiliation  SSRC Health Clinics 
Address  Plot No1278 Road No 63A Jubilee hills Hyderabad
Plot No 1278 63 A

TELANGANA
500033
India 
Phone  7893003300  
Fax    
Email  director@ssrchealth.care  
 
Source of Monetary or Material Support  
Mycobacterial Registry clinical trial is being conducted at Suvana Swasthya research Center at Jubillee Hills. Suvarna Swasthya Research Center will supply being used as per the standard treatment protocol with supplementation of thiamine which is also available in supply. 
 
Primary Sponsor  
Name  Suvarna Swasthya Research Centre 
Address  Plot #1278, Road 63A, Jubilee Hills Hyderabad 500035 Telangana  
Type of Sponsor  Private hospital/clinic 
 
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 
Vijay Yeldandi  Suvarna Swasthya Research Center   SSRC Health Clinics Plot No 1278, Road No 63A Jubilee Hills 500033
Hyderabad
TELANGANA 		 7893003300

director@ssrchealth.care 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S2J Independent Ethics Committee  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 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Month(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Individuals with signs and symptoms of Mycobacterial infection
2. Both males and females and transgender population are eligible for the study
3. Any age group subjects are eligible for the study.
4. All participants must be able to provide consent for themselves or have a parent/ guardian who can provide parental permission or have an authorized legal representative who can provide consent.

 
 
ExclusionCriteria 
Details  1.Hostile or vulnerable patient group (e.g. prisoners and mentally retarded).
2.Patients who are unable to understand the study protocol or are unable to give informed consent or have no legal representative.

 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
A registry can be used to educate healthcare providers about mycobacterial infections, improving awareness and understanding of these infections among clinicians. Data from the registry can help in developing personalized treatment plans based on the specific mycobacterial species and patient demographics.  Ten years 
 
Secondary Outcome  
Outcome  TimePoints 
For patients in whom, the standard therapy has failed, addition of Moxifloxacin could improve treatment outcomes. a clinical and laboratory registry for mycobacterial infections can significantly improve the diagnosis, treatment, and management of these infections, ultimately enhancing patient outcomes and public health in India
 		 Ten years 
 
Target Sample Size   Total Sample Size="10000"
Sample Size from India="10000" 
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)   01/05/2025 
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="10"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Specific request to PI after approval of concerned regulatory agencies

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 27-12-2034?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

In order to allow for the use of the information derived from this clinical Study, there is an obligation on the part of the Study personnel to provide Suvarna Swasthya Research Centre or designee with complete test results and all data developed in this Study, as well as direct access to source data/documents for Study-related monitoring, audits, Independent Ethics

Committee/Institutional Review Board (IEC/IRB) review, and regulatory inspection. All records that support the final case reports of this Study must be retained in the files of the Study for a minimum of 15 years after the completion of the Study. No documents will be destroyed without prior written agreement between Suvarna Swasthya Research Centre and the Study personnel.

 
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