Efficacy and safety of tigecycline versus levofloxacin for community-acquired pneumonia

BMC Pulmonary Medicine

Table 2 Cure Rates at the Test-of-Cure Visit*

	Tigecycline		Levofloxacin		Difference (Tigecycline - Levofloxacin)
	n/N	% (95% CI)	n/N	% (95% CI)	% (95% CI)	Test for Non-inferiority p-Value	Test for Difference p-Value
CE, Overall	128/144	88.9 (82.6,93.5)	116/136	85.3 (78.2, 90.8)	3.6 (-4.5, 11.8)	<0.001	0.4025
Fine <III	60/67	89.6 (79.7, 95.7)	55/63	87.3 (76.5, 94.4)	2.3 (-10.3, 14.8)	0.0026	0.8993
Fine III	34/40	85.0 (70.2, 94.3)	35/42	83.3 (68.6, 93.0)	1.7 (-16.6, 19.9)	0.0388	1.0000
Fine IV	32/35	91.4 (76.9, 98.2)	25/30	83.3 (65.3, 94.4)	8.1 (-11.2, 27.4)	0.0079	0.5463
Fine V	2/2	100.0 (15.8, 100.0)	1/1	100.0 (2.5, 100.0)	0 (-75.0, 75.0)	-	-
Estimated CURB-65 0-1	87/97	89.7 (81.9, 94.9)	79/93	84.9 (76.0, 91.5)	4.7 (-5.6, 15.3)
Estimated CURB-65 2	31/36	86.1 (70.5, 95.3)	30/34	88.2 (72.5, 96.7)	-2.1 (-20.3, 16.6)
CURB-65 ≥ 3	10/11	90.9 (58.7, 99.8)	7/9	77.8 (40.0, 97.2)	13.1 (-25.3, 51.7)
c-mITT	170/203	83.7 (77.9, 88.5)	163/200	81.5 (75.4, 86.6)	2.0 (-5.5, 9.6)	<0.001	0.6269

*At the test-of-cure visit, each patient's response was categorized as one of the following: Cure---All signs and symptoms of pneumonia present at baseline were improved or resolved at test-of-cure with no worsening or appearance of new signs and symptoms of pneumonia and no requirement for further antibiotic therapy. Chest radiographs were improved or not worse. Failure---Persistence or worsening in signs and symptoms of the acute process with either failure to show improvement in the clinical findings, initial improvement in signs and symptoms followed by clinically significant worsening before the test-of-cure assessment, additional antimicrobial therapy required, progression of chest radiograph abnormalities, or death after study day 2 because of pneumonia; or Indeterminate---the patient was lost to follow-up, or died within 2 days after the first dose of study drug for any reason, or died after 2 days because of noninfectious-related reasons or infection other than pneumonia (as judged by the investigator). CE = clinically evaluable population; c-mITT = clinical-modified intent-to-treat population.

ISSN: 1471-2466