| CTRI Number |
CTRI/2025/03/081585 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the Detection of Tuberculosis in Children: Testing Sputum Collected with Saline Nebulization vs. Stomach Fluid Samples |
|
Scientific Title of Study
|
Comparison of the Yield of CBNAAT (Cartridge Based Nucleic Acid Amplification Test) Positivity in Sputum Induced with Nebulized Hypertonic Saline versus Gastric Lavage Samples in Children with Clinically Suspected Pulmonary Tuberculosis: A Diagnostic Accuracy Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lokesh Tiwari |
| Designation |
Professor |
| Affiliation |
AIIMS , Rishikesh |
| Address |
Department Of Pediatrics , AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9631638095 |
| Fax |
|
| Email |
lokeshdoc@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lokesh Tiwari |
| Designation |
Professor |
| Affiliation |
AIIMS , Rishikesh |
| Address |
Department Of Pediatrics , AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9631638095 |
| Fax |
|
| Email |
lokeshdoc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Monica Mahendru |
| Designation |
Research Assistant |
| Affiliation |
AIIMS , Rishikesh |
| Address |
Department of Pediatrics , AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8837864573 |
| Fax |
|
| Email |
monica.mahendru29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cipla Limited , Cipla house , peninsula business park , Ganpatrao kadam Marg ,lower Parel Mumbai, 400013 , Maharashtra , India |
|
|
Primary Sponsor
|
| Name |
Cipla Limited |
| Address |
Cipla House, Peninsula Business Park, Ganpatrao
Kadam Marg, Lower Parel, Mumbai-400013 , India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Lokesh Tiwari |
AIIMS, RISHIKESH |
Room no 016108 , department of pediatrics, division of pediatric pulmonology and Intensive Care
Dehradun
UTTARANCHAL |
09631638095
lokeshdoc@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison |
Comparison of yield of CBNAAT Positivity in sputum induced with nebulized hypertonic saline versus gastric lavage samples in children with clinically suspected pulmonary tuberculosis. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with presumptive pulmonary tuberculosis or disseminated tuberculosis,
defined as a child with any of the symptoms or signs suggestive of TB i.e.(NTEP
guidelines 2023), Fever >2 weeks ,Significant weight loss (loss of >5% of highest weight recorded in the past 3 months)
or not gaining weight, Cough>2weeks, Abnormalities of chest radiograph (parenchymal infiltrate, atelectasis, pleural
effusion, or lymphadenopathy)
ln contact of a TB case - Children with suspected immunodeficiency where PTB has to be ruled out , Children with chronic lung diseases (cystic fibrosis, bronchiectasis) where PTB
should be ruled out |
|
| ExclusionCriteria |
| Details |
Children with a history of prior bronchospasm attributed to inhaled therapies, Children with a history of recent haemoptysis or pneumothorax ,Children with respiratory failure ,Patient with uncontrolled asthma or signs of upper airway obstruction. Unconscious children (GCS <8) or children with convulsions, Patients in whom consent could not be obtained, Children only with extrapulmonary TB |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| sensitivity, specificity, positive predictive value (PPV) Of CBNAAT Of induced sputum and GA respectively compared to the gold standard (MGIT) |
Only one time only at the time of diagnostic testing. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
correlation between two methods of CBNAAT testing (sputum induction vs gastric aspirate/ lavage)
b.To assess the feasibility of inducing an adequate amount of sputum
c. To assess for adverse effects of sputum induction and gastric lavage
d.To see how all three tests (sputum CBNAAT, GA/ GL CBNAAT and MGIT) correlate with clinically significant pulmonary tuberculosis
|
Only one time only at the time of diagnostic testing. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
17/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a diagnostic accuracy study assessing the comparison of the yield of CBNAAT (Cartridge Based Nucleic Acid Amplification Test)
positivity in sputum induced with nebulized hypertonic saline vs gastric lavage
samples in children with clinically suspected pulmonary tuberculosis. The ethical clearance for this study is done and approved and henceforth the document is attached for reference. Through this platform we are registering study for CTRI. |