| CTRI Number |
CTRI/2017/09/009772 [Registered on: 14/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
13/09/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Rifapentine-containing Tuberculosis Treatment Shortening Regimens (S31/A5349) |
|
Scientific Title of Study
|
Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial. ACTG Study A5349
|
| Trial Acronym |
A5349 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT02410772 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushant Meshram |
| Designation |
Professor and Head Dept of Pulmonary Medicine |
| Affiliation |
B J Govt Medical College |
| Address |
BJMC CTU, 1st floor Pathology Museum, BJ Govt medical college and Sassoon General Hospitals
Pune
MAHARASHTRA
411001
India |
| Phone |
02026052419 |
| Fax |
|
| Email |
drsushant.in@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya Mave |
| Designation |
Director and CRS Leader |
| Affiliation |
B J Govt Medical College |
| Address |
BJMC CTU, 1st floor Pathology Museum, BJ Govt medical college and Sassoon General Hospitals
Pune
MAHARASHTRA
411001
India |
| Phone |
02026052419 |
| Fax |
|
| Email |
vidyamave@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishi Suryavanshi |
| Designation |
BJMC CTU, 1st floor Pathology Museum, BJ Govt medical college and Sassoon General Hospitals |
| Affiliation |
B J Govt Medical College |
| Address |
BJMC CTU, 1st floor Pathology Museum, BJ Govt medical college and Sassoon General Hospitals
Pune
MAHARASHTRA
411001
India |
| Phone |
02026052419 |
| Fax |
|
| Email |
nishisuryavanshi@hotmail.com |
|
|
Source of Monetary or Material Support
|
| B.J Medical College Clinical trial Unit. BJ Govt medical college and Sassoon General Hospitals, Jai Prakash Narayan Road, Pune |
|
|
Primary Sponsor
|
| Name |
The Centers for Disease Control and Prevention |
| Address |
1600 Clifton Rd, Atlanta, GA 30333, USA |
| Type of Sponsor |
Other [National public health institute of the United States] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Brazil
China
Haiti
India
Kenya
Malawi
Peru
South Africa
Spain
Thailand
Uganda
United States of America
Viet Nam
Zimbabwe |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sushant Meshram |
B. J Medical College CTU |
OPD no 34, Ground floor, Department of Pulmonary medicine, Sassoon General Hospitals, Jai Prakash Narayan Road, Pune
Pune
MAHARASHTRA |
02026052419
drsushant.in@gmail.com |
| Dr Kumarasamy |
YRG care |
Chennai Antiviral Research and Treatment (CART) CRS
VHS-YRGCARE Medical Centre
Voluntary Health Services
Rajiv Gandhi Salai
Taramani, Chennai-600113
Chennai
TAMIL NADU |
4439106810
kumarasamy@yrgcare.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee B.J.Medical College and Sassoon General Hospital |
Approved |
| Institutional Review Board YRG Care |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Tuberculosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control-standard six-month treatment |
8 weeks of daily treatment with rifampin 600mg isoniazid 300mg pyrazinamide 1000mg, 1500mg, 2000mg depending on weight of patient Ethambutol 800mg, 1200mg, 1600mg depending on weight of patient followed by 18 weeks of treatment with rifampin and Isoniazid
All drugs are administered orally
|
| Intervention |
rifapentine and moxifloxacin- In addition to the single substitution described for regimen 2, a second substitution is added, of moxifloxacin for ethambutol. |
Eight weeks of daily treatment with rifapentine 1200mg, isoniazid 300mg, pyrazinamide 1000mg, 1500mg, 2000mg depending on weight of patient, and moxifloxacin 400mg, followed by Nine weeks of daily treatment with rifapentine, isoniazid and moxifloxacin |
| Intervention |
Rifapentine- Rifapentine is substituted for rifampin as the basis of 4-month treatment |
Eight weeks of daily treatment with rifapentine 1200mg, isoniazid 300mg, pyrazinamide 1000mg, 1500mg, 2000mg depending on weight of patient Ethambutol 800mg, 1200mg, 1600mg depending on weight of patient followed by Nine weeks of daily treatment with rifapentine and isoniazid
All drugs are administered orally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Suspected pulmonary tuberculosis plus one or both of the following at least one sputum specimen positive for acid-fast bacilli on smear microscopy or at least one sputum specimen positive for M tuberculosis by Xpert MTB RIF testing with semiquantitative result of medium or high and rifamycin resistance not detected
Age 18 years and older
A verifiable address or residence location that is readily accessible for visiting and willingness to inform the study team of any change of address during the treatment and follow-up period
Women of child bearing potential who are not surgically sterilized must agree to practice a barrier method of contraception or abstain from heterosexual intercourse during study drug treatment
Documentation of HIV infection status
For HIV-positive individuals CD4 T cell count greater than or equal to 100 cells per mm3 based on testing performed at or within 30 days prior to screening
Karnofsky score greater than or equal to 60
Written informed consent |
|
| ExclusionCriteria |
| Details |
Pregnant or breast-feeding
Unable to take oral medications
Previously enrolled in this study
Received any investigational drug in the past 3 months
More than five days of treatment directed against active tuberculosis within 6 months preceding initiation of study drugs
More than five days of systemic treatment with any one or more of the following drugs within 30 days preceding initiation of study drugs isoniazid rifampin rifabutin rifapentine ethambutol pyrazinamide kanamycin amikacin streptomycin capreomycin moxifloxacin levofloxacin gatifloxacin ofloxacin ciprofloxacin other fluoroquinolones ethionamide prothionamide cycloserine terizidone para-aminosalicylic acid linezolid clofazimine delamanid or bedaquiline
Known history of prolonged QT syndrome
Weight less than 40.0 kg
Known allergy or intolerance to any of the study medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
TB disease free survival at twelve months after study treatment assignment
Proportion of participants with grade 3 or higher adverse events during study drug treatment |
TB disease free survival at twelve months after study treatment assignment
Proportion of participants with grade 3 or higher adverse events during study drug treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TB disease-free survival at eighteen months after study treatment assignment
Time to stable sputum culture conversion
Speed of decline of sputum viable bacilli by automated MGIT days to detection |
Eighteen months after treatment assignment
Four or six months
Four or six months |
|
|
Target Sample Size
|
Total Sample Size="2500"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/06/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/01/2016 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week, with direct observation of each dose by a health-care worker at least five of the seven days of each week. The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and pyrazinamide followed by four months of isoniazid and rifampin. The first short regimen is a single substitution of rifapentine for rifampin: two months of isoniazid, rifapentine, ethambutol, and pyrazinamide, followed by two months of isoniazid and rifapentine. The second short regimen is a double substitution of rifapentine for rifampin and moxifloxacin for ethambutol: two months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide, followed by two months of isoniazid, rifapentine, and moxifloxacin. |