Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial

Table 3 Clinical cure rates* by analysis population at test-of-cure visit

	Tigecycline		Imipenem/cilastatin		Difference (Tigecycline-Imipenem/cilastatin)
Population	N	% (95% CI)	N	% (95% CI)	% (95% CI)
ME	45/52	86.5 (74.2, 94.4)	47/48	97.9 (88.9, 99.9)	-11.4 (-23.5, 0.7)
Monomicrobial	30/33	90.9 (75.7, 98.1)	25/26	96.2 (80.4, 99.9)	-5.2 (-22.0, 13.7)
Polymicrobial	15/19	78.9 (54.4, 93.9)	22/22	100.0 (84.6, 100.0)	-21.1 (-46.1, 2.2)
m-mITT	49/60	81.7 (69.6, 90.5)	50/55	90.9 (80.0, 97.0)	-9.2 (-23.4, 4.9)
Monomicrobial	32/38	84.2 (68.7, 94.0)	27/29	93.1 (77.2, 99.2)	-8.9 (-26.0, 10.7)
Polymicrobial	17/22	77.3 (54.6, 92.2)	23/26	88.5 (69.8, 97.6)	-11.2 (-35.8, 13.0)
CE	67/77	87.0 (77.4, 93.6)	83/87	95.4 (88.6, 98.7)	-8.4 (-18.3, 1.5)
c-mITT	78/97	80.4 (71.1, 87.8)	88/98	89.8 (82.0, 95.0)	-9.4 (-20.3, 1.6)

*Clinical responses defined as: Cure--the course of study drug and the initial intervention (operative and/or radiologically guided drainage procedure) resolved the intra-abdominal infectious process; Failure--the patient required additional antibacterial therapy other than the study drug, the patient required additional surgical or radiologic intervention to cure the infection, death due to infection occurred after 48 hours of therapy or a treatment-related adverse event (AE), or the patient received an extended course of study drug (i.e., > 120% of the planned number of doses); and Indeterminate--the patient was lost to follow-up, or died within 48 hours after the first dose of study drug for any reason, or died after 48 hours because of noninfectious-related reasons (as judged by the investigator).

ISSN: 1471-2334