| CTRI Number |
CTRI/2018/07/014966 [Registered on: 19/07/2018] Trial Registered Prospectively |
| Last Modified On: |
18/07/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Rifapentine-containing tuberculosis treatment shortening regimens(S31/A5349) |
|
Scientific Title of Study
|
A5349: Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial - S31/A5349 Short Title:TBTC S31/A5349: Rifapentine-containing tuberculosis treatment shortening regimens |
| Trial Acronym |
A5349 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Kumarasamy |
| Designation |
Chief Medical Officer |
| Affiliation |
VHS YRGCARE Medical Centre |
| Address |
VHS YRGCARE Medical Centre,
Room #2,Voluntary Health sServices, Taramani, Chennai
Voluntary Health Services, Taramani, Chennai
Chennai
TAMIL NADU
600113
India |
| Phone |
914471026612 |
| Fax |
914422542939 |
| Email |
kumarasamy@yrgcare.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Kumarasamy |
| Designation |
Chief Medical Officer |
| Affiliation |
VHS YRGCARE Medical Centre |
| Address |
VHS YRGCARE Medical Centre, Room #2 Voluntary Health sServices, Taramani, Chennai
Voluntary Health sServices, Taramani, Chennai
Chennai
TAMIL NADU
600113
India |
| Phone |
914471026612 |
| Fax |
914422542939 |
| Email |
kumarasamy@yrgcare.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Kumarasamy |
| Designation |
Chief Medical Officer |
| Affiliation |
VHS YRGCARE Medical Centre |
| Address |
VHS YRGCARE Medical Centre, Voluntary Health sServices, Taramani, Chennai
Voluntary Health sServices, Taramani, Chennai
Chennai
TAMIL NADU
600113
India |
| Phone |
914471026612 |
| Fax |
914422542939 |
| Email |
kumarasamy@yrgcare.org |
|
|
Source of Monetary or Material Support
|
| YRGCARE Medical Centre, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai 600113 |
|
|
Primary Sponsor
|
| Name |
The Centers for Disease Control and Prevention |
| Address |
1600 Clifton Rd Atlanta GA 30333 USA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
BJMC CTU |
OPD NO 34, Ground floor, Department of Pulmonary Medicine, Sassoon General Hospitals , Jai Prakash Narayan Road, Pune, Maharashtra
Pune
MAHARASHTRA |
02026052419
drsushant.in@gmail.com |
| Dr N Kumarasamy |
VHS YRGCARE Medical Center |
Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai
Chennai
TAMIL NADU |
914471026612
914422542939
kumarasamy@yrgcare.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| B J Medical College and Sassoon General Hospital |
Approved |
| VHS YRGCARE IRB |
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 in weight of the participant ethambutol 800mg,1200mg,1600mg depanding on the weight of the participant followed by Eighteen weeks of treatment with rifampin and isoniazid . All drugs are administered orally
8 WEEKS DAILY TREATMENT |
| Intervention |
Rifapentine and Moxifloxacin in addition to the single substitution described for regimen 2 a second substitution is added of moxifloxacin for ethambutol |
8 weeks of daily treatment with rifapentine 1200mg isoniazid 300mg pyrazinamide 1000mg,1500mg,2000mg depending in weight of the participant and moxifloxacin 400mg followed by nine weeks of treatment with rifapentinen isoniazid and moxifloxacin 8 WEEKS DAILY TREATMENT
|
| Intervention |
Rifapentine- Rifapentine is substituted for Rifampin as teh basis of 4 month treatment |
8 weeks of daily treatment with rifapentine 1200mg isoniazid 300mg pyrazinamide 1000mg,1500mg,2000mg depending in weight of the participant ethambutol 800mg,1200mg,1600mg depanding on the weight of the participant followed by nine weeks of treatment with rifapentinen and isoniazid . All drugs are administered orally 8 WEEKS DAILY TREATMENT |
|
|
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 MTBRIF testing, with semiquantitative result of medium or high and rifamycin resistance not detecte
Age 18 years or 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 an adequate method of contraception barrier method or non-hormonal intrauterine device 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 100cells 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 highter adverse events during study drug treatment |
TB disease free survival at twelve months after study treatment assignment
Proportion of participants with grade 3 or highter adverse events during study drug treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TB disease free survival at twelve months after study treatment assignment
Time to stable sputum culture conversion
Speed of decline of sputum viable bacilli by automated MGIT days to detection
Proportion of participants with grade 3 or highter adverse events during study drug treatment |
Eighteen months after treatment assignment
For 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)
|
20/07/2018 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
|
|
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 atleast five of the seven days 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 singly substitution of rifapentine for rifampin: two month so isonisazid ,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 and rifapentine and moxifloxacin |