FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/03/032094 [Registered on: 17/03/2021] Trial Registered Prospectively
Last Modified On: 10/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Other 
Public Title of Study   AbdominaL and Lung Point-of-Care UltraSound for Tuberculosis in Germany and India 
Scientific Title of Study   Assessing the accuracy of point-of-care abdominal and thoracic ultrasound for the diagnosis and therapy monitoring in patients with presumed tuberculosis in India and Germany 
Trial Acronym  ALL POCUS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavitha Saravu 
Designation  Professor and Head 
Affiliation  Kasturba Medical College, Manipal Academy of Higher education, Manipal 
Address  Department of Infectious Diseases, Kasturba Medical College, Madhav Nagar, Manipal
Same as address 1
Udupi
KARNATAKA
576104
India 
Phone  9448107636  
Fax  8202571927  
Email  kavitha.saravu@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Kavitha Saravu 
Designation  Professor and Head 
Affiliation  Kasturba Medical College, Manipal Academy of Higher education, Manipal 
Address  Department of Infectious Diseases, Kasturba Medical College, Madhav Nagar, Manipal
Same as address 1
Udupi
KARNATAKA
576104
India 
Phone  9448107636  
Fax  8202571927  
Email  kavitha.saravu@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Kavitha Saravu 
Designation  Professor and Head 
Affiliation  Kasturba Medical College, Manipal Academy of Higher education, Manipal 
Address  Department of Infectious Diseases, Kasturba Medical College, Madhav Nagar, Manipal
Same as address 1
Udupi
KARNATAKA
576104
India 
Phone  9448107636  
Fax  8202571927  
Email  kavitha.saravu@manipal.edu  
 
Source of Monetary or Material Support  
German Infectious Disease Research Center (DZIF) through Heidelberg University, Germany 
 
Primary Sponsor  
Name  German Infectious Disease Research Center DZIF  
Address  Heidelberg University,Im Neuenheimer Feld 324, 69120 Heidelberg, Germany 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Germany
India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kavitha Saravu  Kasturba Medical College   Department of Infectious Diseases, Kasturba Medical College, Madhav Nagar, Manipal
Udupi
KARNATAKA 		 00919448107636

kavitha.saravu@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Manipal Academy of Higher Education Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A191||Acute miliary tuberculosis of multiple sites, (2) ICD-10 Condition: A183||Tuberculosis of intestines, peritoneum and mesenteric glands, (3) ICD-10 Condition: A154||Tuberculosis of intrathoracic lymph nodes, (4) ICD-10 Condition: A150||Tuberculosis of lung, (5) ICD-10 Condition: A188||Tuberculosis of other specified organs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  We do not have a comparator arm in this study. Treatment of all patients as per treating clinicians. 
Intervention  Point of Care Lung and abdominal USG  This is a diagnostic intervention (like a regular Ultrasound test) which will take maximum 30 minutes. The treatment duration is as decided by the treating clinician. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  - patients aged 16 years or older
- presenting with symptoms compatible with pulmonary TB (PTB) and/or extra-pulmonary (EPTB): At least one of the symptoms below suggestive of TB (as defined by WHO):
o Current cough of 2 weeks or of any duration in PLHIV
o Night sweats
o Fever
o Weight loss
- in Germany another group to enrol will be: patients referred to the study sites because TB is presumed due to radiological, histopathological evidence and where a further TB workup is planned (recognizing the selection bias in the analysis plan)
- Willingness to have a study follow-up visit at 2-3 months after enrolment (e.g. not planning to relocate). Sonographic follow-up (primary objective 3):
- For patients with sonographic findings of TB disease who are treated with anti-TB drugs and who give consent for follow-up ultrasound, US will be repeated at defined timepoints
 
 
ExclusionCriteria 
Details  - no consent given
- already confirmed diagnosis of TB (by sputum microscopy, culture, PCR)
- on anti-tuberculous treatment for more than 24 hours
- on anti-tuberculous treatment within the past 60 days
- on preventive therapy for TB infection within the past 6 months
- Patients presenting with presumed peripheral lymph node TB
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Estimate of sensitivity and specificity of the FASH-protocol with 95% confidence intervals (CI) for TB against MRS, eMRS and CRS

Estimate of sensitivity and specificity of various lung ultrasound findings with 95% CI for TB against MRS, eMRS and CRS

Description of TB-associated sonographic findings during therapy with ranges of time to resolution (median, inter-quartile ranges), size reduction and compared to patients with therapy failure 		 At baseline before the treatment, after 1, 2, 4, 6 months of treatment
treatment) . 
 
Secondary Outcome  
Outcome  TimePoints 
Description of TB-associated sonographic findings during therapy with ranges of time to resolution (median, inter-quartile ranges), size reduction and compared to patients with therapy failure  POC USG done at 1, 2, 4, 6 months of anti-tuberculous treatment  
Sensitivity and specificity of AI-interpretation of POC-US with 95% CI against an expert interpretation and separately against MRS, eMRS and CRS as reference standard   POCUS USG done at admission/ within 24 hours of TB diagnosis. 
 
Target Sample Size   Total Sample Size="770"
Sample Size from India="550" 
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)   01/10/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/10/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   no publications as yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a prospective, multicentre cohort study in which the accuracy and the diagnostic yield of TB-focused POC-US and AI interpretation of US will be assessed using a microbiological reference standard, an extended microbiological reference standard and a composite reference standard among inpatients and outpatients with presumed TB disease.

In presumed tuberculosis patients aged 16 years or older fulfilling the inclusion and exclusion criteria, POC-US with portable US-device using the FASH-protocol and a defined LUS protocol will be done. In proven TB patients, POC-US of findings detected will be followed up at 1, 2, 4, 6 months of anti-tuberculous treatment

Sensitivity and specificity of the FASH-protocol with 95% confidence intervals (CI) for TB against MRS, eMRS and CRS will be estimated. Description of TB-associated sonographic findings during therapy with ranges of time to resolution (median, inter-quartile ranges), size reduction and compared to patients with therapy failure.


 
Close