| CTRI Number |
CTRI/2025/06/088801 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pharmacokinetics of second line anti tuberculosis drugs in Children and Adolescents
with Drug Resistant Tuberculosis |
|
Scientific Title of Study
|
Determination of Pharmacokinetics and Antimycobacterial
Activity of Bedaqualine, Delamanid,
Clofazimine and Linezolid in Children and Adolescents
with Drug Resistant Tuberculosis |
| 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 Aishwarya Venkataraman |
| Designation |
Scientist E |
| Affiliation |
ICMR-NIRT |
| Address |
ICMR-National Institute for Research in Tuberculosis,
No.1, Mayor Sathiyamoorthy Road,
Chetpet, Chennai
Chennai
TAMIL NADU
600031
India |
| Phone |
00914428369500 |
| Fax |
|
| Email |
venkataraman.a@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aishwarya Venkataraman |
| Designation |
Scientist E |
| Affiliation |
ICMR-NIRT |
| Address |
ICMR-National Institute for Research in Tuberculosis,
No.1, Mayor Sathiyamoorthy Road,
Chetpet, Chennai
TAMIL NADU
600031
India |
| Phone |
00914428369500 |
| Fax |
|
| Email |
venkataraman.a@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Venkataraman |
| Designation |
Scientist E |
| Affiliation |
ICMR-NIRT |
| Address |
ICMR-National Institute for Research in Tuberculosis,
No.1, Mayor Sathiyamoorthy Road,
Chetpet, Chennai
TAMIL NADU
600031
India |
| Phone |
00914428369500 |
| Fax |
|
| Email |
venkataraman.a@icmr.gov.in |
|
|
Source of Monetary or Material Support
|
| ICMR
V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
ICMR-National Institute for Research in Tuberculosis,
No.1, Mayor Sathiyamoorthy Road,
Chetpet, Chennai - 600 031 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sushant Mane |
Grant Medical college, Sir JJ Hospital |
J J Marg, Noor Baug, Nagpada, Mumbai Central, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA |
00919820864049
drsush2006@gmail.com |
| Dr Aishwarya Venkataraman |
ICMR-NIRT |
ICMR-National Institute for Research in Tuberculosis,
No.1, Mayor Sathiyamoorthy Road,
Chetpet, Chennai - 600 031
Chennai
TAMIL NADU |
0442836 9500
venkataraman.a@icmr.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Grant Medical College |
Approved |
| ICMR-NIRT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A188||Tuberculosis of other specified organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children with drug resistant TB
Receiving ATT regimen (for DR-TB) as prescribed by the treating paediatrician regularly
for at least four weeks
Should receive at least 3 drugs from Bedaqualine, Delamanid, Clofazimine, Linezolid |
|
| ExclusionCriteria |
| Details |
Caregivers / parents unwilling for hospitalisation and blood sampling |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the highest AUC for Bedaqualine, Delamanid, Clofazimine,and Linezolid that is both safe and tolerable.
|
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Determine the proportion of children with adverse drug reactions to Bedaqualine,
Delamanid, Clofazimine, & Linezolid
To identify factors associated with poor outcomes in children with DR-TB. |
baseline |
|
|
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)
|
23/06/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Data on drug-resistant TB (DR-TB) in children are limited. DR-TB is a growing public health concern for children and worldwide, ~25,000–32,000 children develop MDR-TB each year, of whom <5% receive treatment. One of the reasons is the inadequate dosing recommendations for existing therapies in children. Novelty: This study will provide novel PK data for appropriate drug dosing recommendations for newer anti-TB drugs to be used for the treatment of DR-TB in children and adolescents. Objectives: Primary: Evaluate the pharmacokinetic activity of Bedaqualine, Delamanid, Clofazimine, Linezolid in children and adolescents (3 years to 18 years of age) diagnosed with confirmed or probable drug-resistant tuberculosis (DR-TB). Secondary: To evaluate the safety and tolerability of Bedaqualine, Delamanid, Clofazimine, and Linezolid in children and adolescents To describe the clinical outcome of children and adolescents with DR-TB Methods: This will be a multi-centre, single-arm study where, 100 children and adolescents aged from 3 to 18 years with confirmed or probable DR-TB, including pre-XDR-TB or XDRTB, or MDR-TB will be included. These children will receive age/weight appropriate dose of newer drugs (Bedaqualine, Delamanid, Clofazimine, and Linezolid). Venous blood samples will be collected at 0, 1, 2, 3, 4, 6 and 8 hours post dose to quantify drug concentrations in plasma. Drug concentrations will be quantified using high performance liquid chromatography (HPLC) method which has been validated at ICMR-NIRT. Based on the plasma concentration of drugs obtained at different time points, certain pharmacokinetic variables (peak concentration, time to attain peak concentration, exposure, clearance, half-life) will be calculated by non-compartmental analysis. Expected outcome: To determine the highest AUC for Bedaqualine, Delamanid, Clofazimine, and Linezolid that is both safe and tolerable. Determine the proportion of children with adverse drug reactions to Bedaqualine, Delamanid, Clofazimine, and Linezolid To identify factors associated with poor outcomes in children with DR-TB. |