Once daily oral ofloxacin in chronic obstructive pulmonary disease exacerbation requiring mechanical ventilation: a randomised placebo-controlled trial

Background The role of antibiotics in treatment of patients with moderate e xacerbations of chronic obstructive pulmonary disease (COPD) is uncertain, but such treatment might be useful in very severe episodes. Our objective w as to assess the effects of ofloxacin in patients with exacerbations of COP D who required mechanical ventilation. Methods We did a prospective, randomised, double-blind, placebo-controlled trial in 93 patients with acute exacerbation of COPD who required mechanica l ventilation. Patients were randomly assigned to receive oral ofloxacin 40 0 mg once daily (n=47) or placebo (46) for 10 days. Primary endpoints were death in hospital and need for an additional course of antibiotics, both se parately and in combination. Analysis was by intention to treat. Findings Three patients dropped out of the study. Two (4%) patients receivi ng ofloxacin died in hospital and ten (22%) did so in the placebo group (ab solute risk reduction 17.5%, 95% CI 4.3-30.7, p=0.01). Treatment with oflox acin significantly reduced the need for additional courses of antibiotics ( 28.4%, 12.9-43-9, p=0.0006). The combined frequency of death in hospital an d need for additional antibiotics was significantly lower in patients assig ned to ofloxacin than in those receiving placebo (45.9%, 29.1-62.7, p<0.000 1). The duration of mechanical ventilation and hospital stay was significan tly shorter in the ofloxacin group than in the placebo group (absolute diff erence 4.2 days, 95% CI 2.5-5.9; and 9.6 days, 3.4-12.8, respectively). Interpretation New fluoroquinolones, such as ofloxacin, are beneficial in t he treatment of COPD exacerbation requiring mechanical ventilation.