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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000024

Enrollment

1650

Registered

2008-05-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Pulmonary Tuberculosis

Interventions

Intervention1: 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. Intervention2: Moxifloxacin arm: 4 regimens of 3- to 4-months duration Control Intervention1: 2 RHZE thrice weekly/ 4 RH thrice weekly: Rifampicin 450 mg

Isoniazid 600 mg

Ethambutol 1200 mg. Control Intervention2: Control arm: 6 months

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Relapse rates in those with a favourable or doubtful bacteriological response at the end of treatment. Timepoint: 24 months after completion of treatment	—

Secondary

Measure	Time frame
a) Sputum culture conversion at 2 months of treatment, b) Bacteriological response at end of treatment: c) Adverse reactions to anti-TB drugs Timepoint: 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	—

Measure

Time frame

a) Sputum culture conversion at 2 months of treatment, b) Bacteriological response at end of treatment: c) Adverse reactions to anti-TB drugs Timepoint: 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

—

Countries

India

Contacts

Public ContactMrs. Nirupa Charles

msjawahar@trcchennai.in04428369500

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 23, 2026