Four Months Moxifloxacin Containing Daily Regimen Study Among New Pulmonary Tuberculosis Patients

Summary

The 4-month daily regimen containing moxifloxacin (2HRZEM 7 / 2HRM7) of ICMR-NIRT was studied in 321 sputum positive pulmonary TB patients in a randomised clinical trial. Of the 321, there were 96% with sputum smear grading of 2+/3+ and 80% with \>2 zone involvement in the chest radiograph, The sputum culture conversion at the end of intensive phase was 94%, favourable response at the end of treatment of 92% and the TB recurrence rate was 4.1%. The regimen was safe and well tolerated.

The advantages of a 33% reduction in treatment duration are manifold in terms of financial and other administrative implications. As the next logical step investigators believe that the effectiveness of this shortened regimen that proved successful in our study needs to be tested in the field. Under NTEP the anti-TB drugs are offered as Fixed dose Combination (FDC).3 The HREZ intensive phase and HRE continuation phase FDC are administered to patients based on body weight category. If our proposed study proves successful, the addition of moxifloxacin tablet to the FDC of anti-TB drugs in the intensive and continuation phases of treatment would be feasible under TB program settings. Investigators propose to evaluate 4-month moxifloxacin containing daily regimen \[2 months of HRZEM daily / 2 months of HREM daily (2 HRZEM 7 / 2HREM7)\] in the treatment of newly diagnosed sputum smear positive pulmonary TB patients.

Conditions

• Tuberculosis, Pulmonary

Interventions

DRUG

Isoniazid

Intensive Phase for 2 months and Continuation phase for 2 months dose: 75 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for \>75 Kg) as a fixed-dose combination.

DRUG

Rifampicin

Intensive Phase for 2 months and Continuation phase for 2 months dose: 150 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for \>75 Kg) as a fixed-dose combination.

DRUG

Pyrazinamide

Intensive Phase for 2 months only dose: 400 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for \>75 Kg) as a fixed-dose combination.

DRUG

Ethambutol

Intensive Phase for 2 months and Continuation phase for 2 months dose: 275 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for \>75 Kg) as a fixed-dose combination.

DRUG

Moxifloxacin

Intensive Phase for 2 months and Continuation phase for 2 months dose: 400 mg for 30 to 64 yrs AND 600 mg for 65 and above years of age.

Sponsors & Collaborators

• Indira Gandhi Government Medical College and Hospital (IGGMCH), Nagpur

  collaborator UNKNOWN

• King George's Medical University, Lucknow

  collaborator UNKNOWN

• Mahavir Hospital and Research Centre, Hyderabad

  collaborator UNKNOWN

• Government Vellore Medical College and Hospital, Adukkamparai

  collaborator UNKNOWN

• Lok Nayak hospital, New Delhi

  collaborator UNKNOWN

• Tuberculosis Research Centre, India

  lead OTHER_GOV

Principal Investigators

• Dr. Banurekha MBBS., MPH · National Institute for Research in Tuberculosis, Chennai, India

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-15

Primary Completion

2025-03-31

Completion

2025-03-31

Countries

• India

Study Locations