title: Sputum culture conversion with moxifloxacin-containing regimens in the treatment of patients with newly diagnosed sputum-positive pulmonary tuberculosis in South India.
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.
authors.affiliation: Department of Clinical Research.
authors.forename: Banurekha V
authors.initials: BV
authors.lastname: Velayutham
authors.affiliation: Department of Clinical Research.
authors.forename: Iliayas S
authors.initials: IS
authors.lastname: Allaudeen
authors.affiliation: Department of Bacteriology.
authors.forename: Gomathi N
authors.initials: GN
authors.lastname: Sivaramakrishnan
authors.affiliation: Department of Statistics, National Institute for Research in Tuberculosis (Indian Council of Medical Research).
authors.forename: Venkatesan
authors.initials: V
authors.lastname: Perumal
authors.affiliation: Department of Clinical Research.
authors.forename: Dina
authors.initials: D
authors.lastname: Nair
authors.affiliation: Department of Statistics, National Institute for Research in Tuberculosis (Indian Council of Medical Research).
authors.forename: Ponnuraja
authors.initials: P
authors.lastname: Chinnaiyan
authors.affiliation: Department of Clinical Research.
authors.forename: Paul K
authors.initials: PK
authors.lastname: Paramasivam
authors.affiliation: Department of Clinical Research.
authors.forename: Baskaran
authors.initials: B
authors.lastname: Dhanaraj
authors.affiliation: Department of Clinical Research.
authors.forename: Ramesh K
authors.initials: RK
authors.lastname: Santhanakrishnan
authors.affiliation: Department of Clinical Research.
authors.forename: Gangadevi P
authors.initials: GP
authors.lastname: Navaneethapandian
authors.affiliation: Department of Clinical Research.
authors.forename: Makesh K
authors.initials: MK
authors.lastname: Marimuthu
authors.affiliation: Department of Bacteriology.
authors.forename: Vanaja
authors.initials: V
authors.lastname: Kumar
authors.affiliation: Department of Statistics, National Institute for Research in Tuberculosis (Indian Council of Medical Research).
authors.forename: Chandrasekaran
authors.initials: C
authors.lastname: Kandasamy
authors.affiliation: Department of Clinical Research.
authors.forename: Kalaiselvi
authors.initials: K
authors.lastname: Dharuman
authors.affiliation: Department of Clinical Research.
authors.forename: Thiruvalluvan
authors.initials: T
authors.lastname: Elangovan
authors.affiliation: Department of Institute of Thoracic Medicine.
authors.forename: Meenakshi
authors.initials: M
authors.lastname: Narasimhan
authors.affiliation: Department of Tuberculosis and Chest Diseases, Government Stanley Medical College Hospital.
authors.forename: Sridhar
authors.initials: S
authors.lastname: Rathinam
authors.affiliation: Government Thiruvateeswarar Hospital, Chennai.
authors.forename: Gangadharan
authors.initials: G
authors.lastname: Vadivelu
authors.affiliation: Department of Thoracic Medicine, Government Rajaji Hospital, Madurai.
authors.forename: Prabhakaran
authors.initials: P
authors.lastname: Rathinam
authors.affiliation: Government Hospital for Thoracic Medicine, Tambaram.
authors.forename: Chandrasekar
authors.initials: C
authors.lastname: Chockalingam
authors.affiliation: Chennai Corporation, India.
authors.forename: Lavanya
authors.initials: L
authors.lastname: Jayabal
authors.affiliation: Department of Clinical Research.
authors.forename: Soumya
authors.initials: S
authors.lastname: Swaminathan
authors.affiliation: Department of Clinical Research.
authors.forename: Jawahar M
authors.initials: JM
authors.lastname: Shaheed
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D013902:Radiography, Thoracic; D012042:Registries; D012307:Risk Factors; D013183:Sputum / Q000382:microbiology*; D016896:Treatment Outcome; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000995:Antitubercular Agents; D024841:Fluoroquinolones; D000077266:Moxifloxacin
keywords: culture conversion; intensive phase; moxifloxacin; sputum conversion; tuberculosis