Sputum culture conversion with moxifloxacin-containing regimens in the treatment of patients with newly diagnosed sputum-positive pulmonary tuberculosis in South India

Clin Infect Dis. 2014 Nov 15;59(10):e142-9. doi: 10.1093/cid/ciu550. Epub 2014 Jul 14.

Abstract

Background: Rapid sputum culture conversion at 2 months indicates the sterilizing capacity and potential of regimens to shorten duration of tuberculosis treatment. We compared results of sputum culture conversion by moxifloxacin and control regimens and identified factors affecting sputum culture positivity after 2 months of treatment.

Methods: Human immunodeficiency virus-uninfected adults with newly diagnosed smear-positive pulmonary tuberculosis were randomized to receive a 3- or 4-month moxifloxacin regimen (moxifloxacin [M], isoniazid [H], rifampicin [R], pyrazinamide [Z], ethambutol [E]) or the control regimen (RHZE thrice weekly). Bacteriological assessments were done at 15, 30, 45, and 60 days of treatment. Because all patients in the moxifloxacin groups received 2 months of daily RHZEM, they were grouped together for analysis. Statistical methods included χ(2) test and logistic regression analysis.

Results: Sputum culture conversion was analyzed in 780 (616 in the moxifloxacin group and 164 in the control group) of 801 enrolled patients. Ninety-five percent of 590 patients in the moxifloxacin group and 81% of 151 patients in the control group had negative sputum cultures at month 2 (P < .001). The control regimen, age (≥35 years), initial sputum culture grade (2+ or 3+), and male sex were significantly associated with higher odds of positive sputum cultures at 2 months.

Conclusions: A 5-drug daily regimen with moxifloxacin results in significantly higher sputum culture conversion in the first 2 months compared with a thrice-weekly, 4-drug regimen in patients with newly diagnosed sputum-positive pulmonary tuberculosis.

Keywords: culture conversion; intensive phase; moxifloxacin; sputum conversion; tuberculosis.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antitubercular Agents / administration & dosage
  • Antitubercular Agents / adverse effects
  • Antitubercular Agents / therapeutic use*
  • Drug Administration Schedule
  • Drug Resistance, Bacterial
  • Drug Therapy, Combination
  • Female
  • Fluoroquinolones / administration & dosage
  • Fluoroquinolones / adverse effects
  • Fluoroquinolones / therapeutic use*
  • Follow-Up Studies
  • Humans
  • India
  • Male
  • Middle Aged
  • Moxifloxacin
  • Radiography, Thoracic
  • Registries
  • Risk Factors
  • Sputum / microbiology*
  • Treatment Outcome
  • Tuberculosis, Pulmonary / diagnosis*
  • Tuberculosis, Pulmonary / drug therapy*
  • Young Adult

Substances

  • Antitubercular Agents
  • Fluoroquinolones
  • Moxifloxacin