| CTRI Number |
CTRI/2024/09/074020 [Registered on: 18/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An intervention to prevent TB among the household contacts of drug resistant TB patients in Mumbai |
|
Scientific Title of Study
|
Prevent TB among household contacts of fluoroquinolone resistant drug resistant TB patients in Mumbai |
| 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 Daksha Shah PI |
| Designation |
Executive Health Officer |
| Affiliation |
Brihanmumbai Municipal Corporation (BMC) |
| Address |
Office of EHO
3rd Floor Brihanmumbai Municipal Corporation (BMC)
F South Building
Dr Baba Saheb Ambedkar Road
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9920759805 |
| Fax |
|
| Email |
phdmcgm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VARSHA PURI |
| Designation |
DEPUTY EXECUTIVE HEALTH OFFICER TB |
| Affiliation |
Brihanmumbai Municipal Corporation (BMC) |
| Address |
Office of Deputy Executive Health Officer (T.B.)
1st Floor
Bawalawadi Municipal Office Building
Dr. B. Ambedkar Road
Opposite Voltas House
Chinchpokli
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9920759805 |
| Fax |
|
| Email |
dtomhbmc@rntcp.org |
|
Details of Contact Person
Public Query
|
| Name |
DR VARSHA PURI |
| Designation |
DEPUTY EXECUTIVE HEALTH OFFICER TB |
| Affiliation |
Brihanmumbai Municipal Corporation (BMC) |
| Address |
Office of Deputy Executive Health Officer (T.B.)
1st Floor
Bawalawadi Municipal Office Building
Dr. B. Ambedkar Road
Opposite Voltas House
Chinchpokli
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9920759805 |
| Fax |
|
| Email |
dtomhbmc@rntcp.org |
|
|
Source of Monetary or Material Support
|
| Foreign funding Agency
Centers for Disease Control and Prevention (CDC) & African Society for Lab Medicine ( ASLM)/APHL
|
|
|
Primary Sponsor
|
| Name |
BMC(NTEP) |
| Address |
Brihanmumbai Municipal Corporation (BMC), Mumbai F South Building, 3rd Floor, Dr Baba Saheb Ambedkar Road, Parel, Mumbai – 400012 |
| Type of Sponsor |
Other [Brihanmumbai Municipal Corporation (BMC)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SHARE INDIA |
MIMS Campus Ghanpur village Medchal Malkajgiri district Telangana 501401 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Daksha Shah |
F South Parel District TB Centre Mumbai |
Office of Executive Health officer, F South Building, 3rd Floor, Dr Baba Saheb Ambedkar Road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
9920759806
phdmcgm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MDACS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
household contacts of DR-TB patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Prevent TB among household contacts of fluoroquinolone resistant drug resistant TB patients in Mumbai |
Total 15 months out of which 9 months for participant recruitment and 6 months of preventive treatment to the participants |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age Adults greater than 18 years and children aged greater than 5 years HHCs.
2. All HHCs of an index bacteriologically phenotype or genotype confirmed DR TB patients resistant to FQ.
3. Willing for study procedures.
4. Willing to provide written informed consent, adults greater than 18years and assent for children aged greater than 6years. |
|
| ExclusionCriteria |
| Details |
1. Critically ill
2. Unable to take oral medications
3. Body weight lesser than 16 Kg
4. Current smear or GeneXpert or LPA or culture confirmed or clinically diagnosed Pulmonary or Extra pulmonary TB
5. Currently receiving anti TB treatment
6. Past AntiTB treatment at any time for more than 1 month during 1 year prior to enrolment
7. All HHCs of an index bacteriologically phenotype or genotype confirmed FQ resistant DR TB patients with Mtb resistant to Delamanid by tNGS or pDST.
8. Participants with abnormal chest X ray that cannot be excluded from having TB disease
9. Alcohol or substance use or dependence
10. Significant cardiac arrhythmia requiring medication
11. Study participants who have QTcF interval on ECG more than 450 m sec at screening.
12. Females who have a positive pregnancy test at screening or already known to be pregnant, breast feeding, or planning to conceive a child during the study or within 6 months of cessation of treatment. Males planning to conceive a child during the study or within 6 months of cessation of treatment.
13. Study participants with the following laboratory values as defined by the enhanced Division of Microbiology and Infectious Disease DMID adult toxicity table November 2007 at screening will be excluded labs may be repeated
In the absence of clinical symptoms if
a. Aspartate aminotransferase AST greater than or equal to 5.0 ULN
b. Alanine aminotransferase ALT than or equal5.0 ULN.
c. Total bilirubin than or equal 1.2 ULN.
- In the presence of Clinical symptoms if
a. Aspartate aminotransferase AST than or equal 3.0 ULN
b. Alanine aminotransferase ALT than or equal 3.0 ULN.
c. Total bilirubin than or equal ULN.
14. Malignancy
15. Any condition in the investigators opinion where participation in the study would compromise the well being of study participant or prevent, limit or confound protocol specified assessments
16. Evidence or History of known drug allergy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of TB among the participants |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of participants having TBI 12months
2. Proportion of participants who were initiated on TPT 12 months
3. Proportion of participants who developed ADRs due to DLM preventive therapy 12months
4. Proportion of participants who completed the DLM TPT 15months
5. Proportion of participants who developed TB diseases in follow up 18 months & 24 months
|
12months
15months
18months
24months |
|
|
Target Sample Size
|
Total Sample Size="3313"
Sample Size from India="3313"
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)
|
01/10/2024 |
| 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="6"
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 - NO
|
|
Brief Summary
|
This study is a non randomized single arm interventional study To determine the usefulness of Delamanid DLM as tuberculosis preventive treatment TPT for household contacts of fluoroquinolone resistant pulmonary drug resistant adult tuberculosis patients in five districts of Mumbai. This study will provide evidence on the feasibility of DLM in preventing TB among HHCs of DR TB patients in India. |