| CTRI Number |
CTRI/2008/091/000024 [Registered on: 09/05/2008] |
| Last Modified On: |
06/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effectiveness and safety of 3- and 4-month regimens as compared to the standard 6-month regimen for the treatment of infectious pulmonary tuberculosis patients |
|
Scientific Title of Study
|
RANDOMISED CLINICAL TRIAL TO STUDY THE EFFICACY AND TOLERABILITY OF 3- AND 4-MONTH REGIMENS CONTAINING MOXIFLOXACIN IN THE TREATMENT OF PATIENTS WITH SPUTUM SMEAR AND CULTURE POSITIVE PULMONARY TUBERCULOSIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. M S Jawahar |
| Designation |
|
| Affiliation |
|
| Address |
Tuberculosis Research Centre
Mayor V R Ramanathan Road, Chetput
Chennai
TAMIL NADU
600031
India |
| Phone |
04428369500 |
| Fax |
|
| Email |
msjawahar@trcchennai.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. M S Jawahar |
| Designation |
|
| Affiliation |
|
| Address |
Tuberculosis Research Centre
Mayor V R Ramanathan Road, Chetput
Chennai
TAMIL NADU
600031
India |
| Phone |
04428369500 |
| Fax |
|
| Email |
msjawahar@trcchennai.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs. Nirupa Charles |
| Designation |
|
| Affiliation |
|
| Address |
Tuberculosis Research Centre
Mayor V R Ramanathan Road, Chetput
Chennai
TAMIL NADU
600031
India |
| Phone |
04428369513 |
| Fax |
|
| Email |
|
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. M S Jawahar |
Chennai |
Tuberculosis Research Centre,Mayor V R Ramanathan Road, Chetput-600031
Chennai
TAMIL NADU |
04428369500
msjawahar@trcchennai.in |
| Dr. P Paul Kumaran |
Madurai |
Tuberculosis Research Centre,Chest Clinic, Rajaji Hospital-625020
Madurai
TAMIL NADU |
4522534351
ppaulkumaran@trcchennai.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Pulmonary Tuberculosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 RHZE thrice weekly/ 4 RH thrice weekly |
Rifampicin 450 mg; Isoniazid 600 mg; Pyrazinamide 1500 mg; Ethambutol 1200 mg. |
| Intervention |
3 RHZEM, 2 RHZEM/2 RHM, 2 RHZEM/2 RHM thrice weekly, 2 RHZEM/2 RHEM thrice weekly |
Dose: Rifampicin 450 mg; Isoniazid 300 mg (daily), 600 mg (thrice weekly); Pyrazinamide 1500 mg; Ethambutol 800 mg (Daily), 1200 mg (Thrice weekly); Moxifloxacin 400 mg. |
| Comparator Agent |
Control arm |
6 months |
| Intervention |
Moxifloxacin arm |
4 regimens of 3- to 4-months duration |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a. Age 18 years to 60 years
b. Residing in or around Chennai or Madurai
c. No previous anti-TB treatment
d. At least two sputum smears should be positive for tubercle bacilli by fluorescent microscopy at enrollment
e. Willing to attend the treatment centre for supervised treatment
f. Willing for home visits by the staff of the center.
g. Willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
a. Body weight less than 30 kg
b. Hepatic or renal disease as evidenced by clinical or biochemical abnormalities
c. Diabetes mellitus
d. History of seizure or loss of consciousness
e. Psychiatric illness
f. Abnormal electrocardiogram or anti-arrhythmic medication
g. Those in a moribund state
h. Sero-positive for HIV antibodies
i. Pregnancy or lactation
j. Visual disorders other than refractory error
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relapse rates in those with a favourable or doubtful bacteriological response at the end of treatment.
|
24 months after completion of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a) Sputum culture conversion at 2 months of treatment,
b) Bacteriological response at end of treatment:
c) Adverse reactions to anti-TB drugs
|
a) Sputum culture conversion at 2 months of treatment will be assessed at 5 months from start of treatment.
d) Bacteriological response at end of treatment will be assessed at 6 to 9 months depending on the regimen.
c) Adverse reactions to anti-TB drugs will be monitored throughout the treatment phase, 3 to 6 months depending on the regimen |
|
Target Sample Size
Modification(s)
|
Total Sample Size="1650"
Sample Size from India="1650"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/05/2007 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="8"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Shortening the duration of TB treatment is a research priority. The main aim of this study is to shorten the duration of TB treatment to 3 or 4 months compared to the standard treatment duration of 6 months, by strengthening the standard 4-drug TB regimen by the addition of moxifloxacin. Moxifloxacin has been shown to have potent bactericidal and sterilising activities against Mycobacterium tuberculosis. The safety of these regimens is also being monitored.
Enrollment to the study is in progress in Chennai and Madurai. As of the end oft December 2011, 605 patients have been enrolled in this trial out of a targeted sample size of 1650 patients. Interim analysis of the data has shown that patients treated with the moxifloxacin-containing regimens become sputum culture negative earlier and to a greater extent than those treated with the control regimen. Results at the end of treatment were similar for all the regimens, but TB recurrence was significantly higher in those treated with the 3-month moxifloxacin regimen compared to the other regimens. Based on the recommendation of the Data and Safety Monitoring Board (DSMB), recruitment to this arm has been temporarily suspended. Recruitment to the other four regimens of the trial is continuing. |