| CTRI Number |
CTRI/2019/04/018577 [Registered on: 12/04/2019] Trial Registered Prospectively |
| Last Modified On: |
11/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Synergistically acting Rifampicin and Faropenem in Tuberculosis |
|
Scientific Title of Study
|
Early Bactericidal activity (EBA) of Rifampicin and Faropenem in Tuberculosis(Rifampicin Susceptible ) |
| Trial Acronym |
RIFAST |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not required |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Urvashi B Singh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Microbiology,
AIIMS,
New Delhi.
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drurvashi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Urvashi B Singh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Microbiology,
AIIMS,
New Delhi.
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drurvashi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Urvashi B Singh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Microbiology,
AIIMS,
New Delhi.
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drurvashi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V Ramalingaswami Bhawan
PO Box No. 4911
Ansari Nagar New Delhi 110029 India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Urvashi B Singh |
All India Institute of Medical Sciences |
Ansari Nagar, New Delhi 110029
South
DELHI |
9811120203
drurvashi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AIIMS |
To compare the Early Bactericidal Activity (EBA) and Whole Blood Bactericidal Activity (WBA) of different novel TB treatment regimens to that of the standard of care in TB patients. |
| Intervention |
RBIPMT |
Four groups of 14 patients each with smear positive Rifampicin sensitive, pulmonary TB will be randomly allocated. Control group (Group 1) patients will be offered standard of care treatment while Group 2 will receive the novel regimen, consisting of Rif+Faropenem +Clavulanate. Third group will include Rifampicin sensitive, INH resistant pulmonary TBand will be given novel regimen, consisting of Rif+Faropenem+Clavulanate. Fourth group will constitute of patients with INH resistance and on standard of care regimen under RNTCP. 7 day EBA and WBA will be carried out in all the groups.Standard dose of Rifampicin (450/600 mg) along with 200 mg BD Faropenem will be given for 7days followed by the standard of care regimen under RNTCP. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Clinical suspicion of pulmonary TB: persistent productive cough for ≥ 2 weeks
Patient volunteers to give 2 sputum specimens over the course
Age 18 years and above
Willing and able to give valid informed written consent Patients free from any other disease or infection of lung such as Sarcoidosis COPD Lung Cancer etc
|
|
| ExclusionCriteria |
| Details |
Known hypersensitivity to anti-TB drugs
Patients with extra-pulmonary TB
Patients with any other chronic pulmonary diseases
Presence of secondary immunodeficiency states; organ transplantation diabetes mellitus malignancy treatment with corticosteroids
Pregnancy and lactation
Patients unlikely to comply with the treatment regimen
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome of EBA will be 7 days measured by the daily rate of change of log10CFU in sputum (EBACFU0–7). The slopes can be described by linear, bilinear, or multiple regression depending on which method fits the data best. Secondary endpoints include the EBACFU days 0–2, EBACFU days 2–7, EBACFU days 0–7. EBATTP will be assessed in an analogous fashion from the daily prolongation of TTP over the relevant time period.
|
The primary efficacy endpoint will be
1. the EBA over 7 days measured by the daily rate of change of log10CFU in sputum (EBACFU0–7).
The slopes can be described by linear, bilinear, or multiple regression depending on which method fits the data best. 2.Secondary endpoints include the EBACFU days 0–2, EBACFU days 2–7, EBACFU days 0–7.
3.EBA TTP will be assessed in an analogous fashion from the daily prolongation of TTP over the relevant time period.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary endpoints include the EBACFU days 0–2, EBACFU days 2–7, EBACFU days 0–7. EBATTP will be assessed in an analogous fashion from the daily prolongation of TTP over the relevant time period.
|
Secondary endpoints timepoint include the EBACFU at days 0–2, EBACFU days at 2–7, and at EBACFU days 0–7. EBATTP will be assessed in an analogous fashion from the daily prolongation of TTP over the relevant time period.
|
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="14"
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)
|
31/05/2019 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The current study is proposed to design an efficient, all oral, shorter regimen for TB treatment. The innovation driving our approach is the synergistic activity anti-tuberculosis activity observed between rifampicin and certain beta-lactam antibiotics and between certain classes of beta-lactam themselves. Different groups have demonstrated clinically relevant inhibition of MTB in the presence of penems and cephalosporins used alone or in combination with Rifampicin and Ethambutol. The proven safety of Penems,their bioavailability along with the proven anti-mycobacterial activity and synergism with Rifampicin,makes the proposal promising. |