Latency in Pulmonary Tuberculosis
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ClinicalTrials.gov Identifier: NCT01154959 |
Recruitment Status : Unknown
Verified June 2011 by Tuberculosis Research Centre, India.
Recruitment status was: Recruiting
First Posted : July 1, 2010
Last Update Posted : June 16, 2011
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Condition or disease | Intervention/treatment | Phase |
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Pulmonary Tuberculosis | Drug: Moxifloxacin, Isoniazid, Rifampicin Pyrazinamide, Ethambutol | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Characterization of Immune Responses in Treatment-induced Latency in Pulmonary Tuberculosis |
Study Start Date : | February 2010 |
Estimated Primary Completion Date : | February 2013 |
Estimated Study Completion Date : | February 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Regimen 1
Rifampicin, isoniazid, pyrazinamide, ethambutol and moxifloxacin daily for 3 months (3RHZEM)
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Drug: Moxifloxacin, Isoniazid, Rifampicin Pyrazinamide, Ethambutol
Moxifloxacin (400mg), Isoniazid (300mg daily, 600mg thrice weekly), Rifampicin (450mg, and 600mg for patients weighing 60kg or more), Pyrazinamide (1500mg), Ethambutol (800mg) |
Experimental: Regimen 2
Rifampicin, isoniazid, pyrazinamide, ethambutol and moxifloxacin daily for 2 months followed by rifampicin, isoniazid, and moxifloxacin daily for 2 months (2 RHZEM daily / 2 RHM daily)
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Drug: Moxifloxacin, Isoniazid, Rifampicin Pyrazinamide, Ethambutol
Moxifloxacin (400mg), Isoniazid (300mg daily, 600mg thrice weekly), Rifampicin (450mg, and 600mg for patients weighing 60kg or more), Pyrazinamide (1500mg), Ethambutol (800mg) |
Experimental: Regimen 3
Rifampicin, isoniazid, pyrazinamide, ethambutol and moxifloxacin daily for 2 months followed by rifampicin, isoniazid, and moxifloxacin thrice weekly for 2 months (2 RHZEM daily / 2RHM thrice weekly)
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Drug: Moxifloxacin, Isoniazid, Rifampicin Pyrazinamide, Ethambutol
Moxifloxacin (400mg), Isoniazid (300mg daily, 600mg thrice weekly), Rifampicin (450mg, and 600mg for patients weighing 60kg or more), Pyrazinamide (1500mg), Ethambutol (800mg) |
Experimental: Regimen 4
Rifampicin, isoniazid, pyrazinamide, ethambutol and moxifloxacin daily for 2 months followed by rifampicin, isoniazid, ethambutol and moxifloxacin thrice weekly for 2 months (2 RHZEM daily / 2 RHEM thrice weekly)
|
Drug: Moxifloxacin, Isoniazid, Rifampicin Pyrazinamide, Ethambutol
Moxifloxacin (400mg), Isoniazid (300mg daily, 600mg thrice weekly), Rifampicin (450mg, and 600mg for patients weighing 60kg or more), Pyrazinamide (1500mg), Ethambutol (800mg) |
Active Comparator: Control Regimen
Rifampicin, isoniazid, pyrazinamide and ethambutol thrice weekly for 2 months followed by rifampicin and isoniazid thrice weekly for 4 months (2 RHZE thrice weekly / 4 RH thrice weekly)
|
Drug: Moxifloxacin, Isoniazid, Rifampicin Pyrazinamide, Ethambutol
Moxifloxacin (400mg), Isoniazid (300mg daily, 600mg thrice weekly), Rifampicin (450mg, and 600mg for patients weighing 60kg or more), Pyrazinamide (1500mg), Ethambutol (800mg) |
- The immune response to crude antigens - PPD and CFA and defined antigens - ESAT-6 and CFP-10 as well as positive controls- SEB and anti-CD3. [ Time Frame: 2 years ]
- Determining the correlation of increase in regulatory factors with the development of relapse in treated TB patients. [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 years and above
- Residing in or around Chennai or Madurai
- No anti-TB treatment in the past or should have had less than one month of treatment (but less than one week in the preceding one month before enrollment in the study)
- At least two sputum smears should be positive for tubercle bacilli by fluorescent microscopy
- Express willingness to attend the treatment centre for supervised treatment
- Express willingness for home visits by the staff of the centre
- Express willingness to give written informed consent
Exclusion Criteria:
- Body weight less than 30 kg
- Hepatic or renal disease as evidenced by clinical or biochemical abnormalities
- Diabetes mellitus
- A history of seizure or loss of consciousness
- Psychiatric illness
- An abnormal electrocardiogram or anti-arrhythmic medication
- Those in a moribund state
- Sero-positive for HIV antibodies
- Pregnancy or lactation
- Visual disorders other than refractory error

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154959
Contact: Subash Babu, MBBS, PhD | 91-44-28369711 | sbabu@niaid.nih.gov | |
Contact: Pavan Kumar, MSc | 91-44-28369766 | pavankumarn@trcchennai.in |
India | |
Tuberculosis Research Centre | Recruiting |
Chennai, Tamilnadu, India, 600031 | |
Contact: Subash Babu, MBBS, PhD 91-44-28369711 sbabu@niaid.nih.gov | |
Contact: Pavan Kumar, MSc 91-44-28369766 pavankumarn@trcchennai.in | |
Principal Investigator: Subash Babu, MBBS, PhD |
Principal Investigator: | Subash Babu, MBBS, PhD | Tuberculosis Research Centre, India |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr. S. Subash Babu, Tuberculosis Research Centre (ICMR) |
ClinicalTrials.gov Identifier: | NCT01154959 |
Other Study ID Numbers: |
LTB01 |
First Posted: | July 1, 2010 Key Record Dates |
Last Update Posted: | June 16, 2011 |
Last Verified: | June 2011 |
Pulmonary TB Immune response ATT Immune responses in pulmonary tuberculosis Predictors for relapse |
Tuberculosis Tuberculosis, Pulmonary Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Moxifloxacin Rifampin Isoniazid Pyrazinamide Ethambutol Anti-Bacterial Agents |
Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antibiotics, Antitubercular Antitubercular Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers |