| CTRI Number |
CTRI/2019/07/020048 [Registered on: 05/07/2019] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB) |
|
Scientific Title of Study
|
A5300B/I2003B/PHOENIx A Phase III, open-label, multicenter trial with a cluster-randomized superiority design to compare the efficacy and safety of delamanid (DLM) versus isoniazid (INH) for preventing confirmed or probable active TB during 96 weeks of follow-up among high-risk household contacts (HHCs) of adults with multidrug-resistant tuberculosis (MDR-TB) |
| Trial Acronym |
PHOENIx MDR-TB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT03568383 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Gaikwad |
| Designation |
Professor and Head |
| Affiliation |
BJ Medical College and Sassoon General Hospital |
| Address |
Department of Pulmonary Medicine, BJ Medical College and Sassoon General Hospital Jai Prakash Narayan Road
Pune
MAHARASHTRA
411001
India |
| Phone |
02026052419 |
| Fax |
|
| Email |
drsanjaytbres@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya Mave |
| Designation |
CRS Leader |
| Affiliation |
BJ Medical College and Sassoon General Hospital |
| Address |
B J Medical College Clinical Trial Unit (BJMC-CTU)
BJ Medical College and Sassoon General Hospital,1st Floor, Pathology Museum, Jai Prakash Narayan Road
Pune
MAHARASHTRA
411001
India |
| Phone |
02026052419 |
| Fax |
|
| Email |
vidyamave@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishi Suryavanshi |
| Designation |
CRS Coordinator |
| Affiliation |
BJ Medical College and Sassoon General Hospital |
| Address |
B J Medical College Clinical Trial Unit (BJMC-CTU)
BJ Medical College and Sassoon General Hospital,1st Floor, Pathology Museum, Jai Prakash Narayan Road
Pune
MAHARASHTRA
411001
India |
| Phone |
02026052419 |
| Fax |
|
| Email |
nishisuryavanshi@hotmail.com |
|
|
Source of Monetary or Material Support
|
| National Institutes of Health (NIH) Maryland 20892 USA |
|
|
Primary Sponsor
|
| Name |
NIH DAIDS |
| Address |
Maryland USA |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| BJ Govt Medical College |
BJMC CTU 1st Floor Pathology Museum Jai Prakash Narayan Road Pune 411001 Maharashtra India |
|
|
Countries of Recruitment
|
India
Botswana
Brazil
Haiti
Kenya
Peru
Philippines
South Africa
Tanzania
Thailand
Uganda
Zimbabwe |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Gaikwad |
B J Medical College Clinical Trial Unit (BJMC-CTU) |
BJMC-CTU1st Floor, Pathology Museum, B J Medical College and Sassoon General Hospitals Jai Prakash Narayan Road, Pune 411001
Pune
MAHARASHTRA |
02026052419
drsanjaytbres@gmail.com |
| DrAmrosePradeep |
YRGCARE |
Oldno15newno34EastStreetKilpaukGardenColonyChennai600010
Chennai
TAMIL NADU |
914428363200
914422542939
clinic@yrgcare.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee B J Medical College & Sassoon General Hospitals |
Approved |
| YRG Care Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, (2) ICD-10 Condition: A15-A19||Tuberculosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Delamanid (DLM) |
1. Adults and children ≥30 kg: delamanid 200 mg orally once daily.
2. Children ≥2.5 kg to 30 kg: weight-band dosing orally once daily as per the study protocol. As children gain weight, their DLM dose should be adjusted, typically every month or as the visit schedule permits |
| Comparator Agent |
Isoniazid (INH) |
1.Adults and children ≥24 kg: INH 300 mg orally once daily
2.Children ≥2.5 kg to 24 kg: INH weight-band dosing orally once daily as per the study protocol. As children gain weight, their INH dose should be adjusted. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
85.01 Year(s) |
| Gender |
Both |
| Details |
INDEX CASE:age greater >18 years, patients with Pulmonary MDR-TB, Ability and willingness of the index case to provide informed consent to access the HH and approach HH members for evaluation. HH of index case has at least one reported HHC.HOUSEHOLD CONTACTS : Currently lives or lived in the same dwelling unit or plot of land and shares or has shared the same housekeeping arrangements as the index case and who reports exposure within 90 days prior to the index case starting MDR-TB treatment. Also, shared greater than 4 hours of indoor airspace with the index case during any one-week period prior to the index case starting MDR-TB treatment.;HHCs must be in one of the following high-risk groups:All children 0 - 5 years old at the time of enrollment ,Adults, adolescents, and children > 5 years of age who are TST+, Adults, adolescents, and children greater > 5 years of age who are HIV-infected or are non-HIV immunosuppressed regardless of TST or IGRA status. HIV-1 infection status must be documented , The following specific laboratory values for infants, children, adolescents, and adults obtained within 30 days prior to study entry by any DAIDS-approved non-US laboratory that operates in accordance with GCLP and participates in appropriate external quality assurance programs.
|
|
| ExclusionCriteria |
| Details |
INDEX CASE :enrolled previously :HHC: TB: Receipt of more than 30 cumulative days of INH,rifamycin,fluoroquinolone,or DLM,Evidence of acute hepatitis ,abdominal pain,nausea & vomiting, jaundice, dark urine,& or light stools in the 90 days prior to study entry, liver cirrhosis .Peripheral neuropathy ,allergy sensitivity or any hypersensitivity to components of study drugs or their formulation,Serious illness. Medication with potential for adverse drug-drug interactions, QT prolongation. Taken an investigational IP or vaccine within 30 days prior to study entry .cardiovascular disorder, active drug or alcohol use or dependence. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| % of participants with confirmed or probable active TB at any time between Day 0 and the week 96 study visit TB diagnoses will be reviewed by the independent outcomes review committee to assess whether the HHC had TB, if it was confirmed or probable TB,and if it was MDR-TB..% of participants who permanently discontinue randomized study drug due to a treatment-related AE.Requiring discontinuation as defined in the protocol, or in the opinion of the site investigator is a treatment-limiting AE |
Measured through Week 96 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percent of participants with confirmed active MDR-TB at any time between Day 0 and the week 96 study visit |
Measured through Week 96 |
Percent of participants who died from any cause at any time between Day 0 and 96 weeks of follow-up .
Deaths will be reviewed by the independent outcomes review committee to assess whether the HHC had TB at the time of death, possibly undiagnosed, and relatedness of the death to TB. |
Measured through Week 96 |
Percent of participants who died from any cause at any time between Day 0 and 96 weeks of follow-up, or with confirmed or probable active TB at any time between Day 0 and the week 96 study visit.
Deaths and TB diagnoses will be reviewed by the independent outcomes review committee to assess whether the HHC had TB at the time of death, possibly undiagnosed, and relatedness of the death to TB; and whether the HHC had TB, if it was confirmed or probable TB, and if it was MDR-TB. |
Measured through Week 96 |
Percent of participants with a Grade 3 or higher adverse event during the period receiving randomized study drug (DLM or INH)
If a HHC has a Grade 3 or higher adverse event prior to starting randomized study drug, then the same event will only be considered during follow-up if the grade worsens. |
Measured through Week 26 |
|
|
Target Sample Size
|
Total Sample Size="5610"
Sample Size from India="500"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/06/2019 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="6"
Months="1"
Days="21" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Trial not yet commenced |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB) A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care [(SOC) isoniazid/rifampicin/pyrazinamide/ethambutol (HRZE)] The study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of experimental or SOC treatment (based on treatment arm assignment) followed by 18 weeks of SOC treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm |