We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Randomized Clinical Trial of Thrice-Weekly 4-Month Moxifloxacin or Gatifloxacin Containing Regimens in the Treatment of New Sputum Positive Pulmonary Tuberculosis Patients.
- Authors
Jawahar, Mohideen S.; Banurekha, Vaithilingam V.; Paramasivan, Chinnampedu N.; Rahman, Fathima; Ramachandran, Rajeswari; Venkatesan, Perumal; Balasubramanian, Rani; Selvakumar, Nagamiah; Ponnuraja, Chinnaiyan; Iliayas, Allaudeen S.; Gangadevi, Navaneethapandian P.; Raman, Balambal; Baskaran, Dhanaraj; Kumar, Santhanakrishnan R.; Kumar, Marimuthu M.; Mohan, Victor; Ganapathy, Sudha; Kumar, Vanaja; Shanmugam, Geetha; Charles, Niruparani
- Abstract
Background: Shortening tuberculosis (TB) treatment duration is a research priority. This paper presents data from a prematurely terminated randomized clinical trial, of 4-month moxifloxacin or gatifloxacin regimens, in South India. Methods: Newly diagnosed, sputum-positive HIV-negative pulmonary TB patients were randomly allocated to receive gatifloxacin or moxifloxacin, along with isoniazid and rifampicin for 4 months with pyrazinamide for first 2 months (G or M) or isoniazid and rifampicin for 6 months with ethambutol and pyrazinamide for first 2 months (C). All regimens were administered thrice-weekly. Clinical and bacteriological assessments were done monthly during treatment and for 24 months post-treatment. The Data and Safety Monitoring Board recommended termination of the trial due to high TB recurrence rates in the G and M regimens. Results: Of 416 patients in intent-to-treat analysis, 6 (5%) of 124, 2 (2%) of 110 and 2 (2%) of 137 patients with drug-susceptible TB in the G, M and C arms respectively had unfavorable response at the end of treatment; during the next 24 months, 17 (15%) of 115, 11 (11%) of 104 and 8 (6%) of 132 patients respectively, had TB recurrence. Of 38 drug-resistant patients 1 of 8 and 3 of 26 in the G and C arms respectively had unfavourable response at the end of treatment; and TB recurrence occurred in 2 of 7 and 2 of 23 patients, respectively. The differences in TB recurrence rates between the G and C arms was statistically significant (p = 0.02). Gastro-intestinal symptoms occurred in 23%, 22% and 9% of patients in the G, M and C arms respectively, but most reactions were mild and manageable with symptomatic measures; 1% required regimen modification. Conclusions: 4-month thrice-weekly regimens of gatifloxacin or moxifloxacin with isoniazid, rifampicin and pyrazinamide, were inferior to standard 6-month treatment, in patients with newly diagnosed sputum positive pulmonary TB. Trial Registration: Clinical Trials Registry of India CTRI/2012/10/003060
- Subjects
MOXIFLOXACIN; TUBERCULOSIS patients; PYRAZINAMIDE; TUBERCULOSIS treatment; DISEASE relapse; CLINICAL trials; DRUG resistance in microorganisms
- Publication
PLoS ONE, 2013, Vol 8, Issue 7, p1
- ISSN
1932-6203
- Publication type
Article
- DOI
10.1371/journal.pone.0067030