Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects

Conditions

Cross Infection, Gram-Positive Bacterial Infections

Keywords

Bacterial Infections

Brief summary

Purpose: To provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.

Kongnakorn T, Eckmann C, Bassetti M, Tichy E, Di Virgilio R, Baillon-Plot N, Charbonneau C.

2019-12-2113 citations

10.1186/s13756-019-0652-x

A multicenter, double-blind, randomized, comparison study of the efficacy and safety of tigecycline to imipenem/cilastatin to treat complicated intra-abdominal infections in hospitalized subjects in China

Yijian Chen, Demei Zhu, Yingyuan Zhang, Yongjie Zhao, Gang Chen et al. (12 authors)

Therapeutics and Clinical Risk Management2018-11-0112 citations

10.2147/tcrm.s171821

Ceftolozane/Tazobactam Plus Metronidazole for Complicated Intra-abdominal Infections in an Era of Multidrug Resistance: Results From a Randomized, Double-Blind, Phase 3 Trial (ASPECT-cIAI)

Joseph S. Solomkin, Ellie Hershberger, Benjamin Miller, Myra W. Popejoy, Ian R. Friedland et al. (11 authors)

Clinical Infectious Diseases2015-02-10400 citations

10.1093/cid/civ097

Clinical experience in 52 patients with tigecycline-containing regimens for salvage treatment of Mycobacterium abscessus and Mycobacterium chelonae infections.

Wallace RJ, Dukart G, Brown-Elliott BA, Griffith DE, Scerpella EG, Marshall B.

2014-03-14138 citations

10.1093/jac/dku062

Interventions

DRUGTigecycline

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

8 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Male or female subjects, ≥ 8 years of age and a weight of ≥ 35 kilograms * Subjects with selected culture-positive infections caused by a multiple antibiotic-resistant pathogen presumed to be susceptible to tigecycline * Subjects who have failed or are intolerant of other available appropriate antibiotic therapies or whose pathogens are resistant to other available antibiotics

Exclusion criteria

* Subjects who are moribund with an expected survival of less than 2 weeks. * Subjects who have been designated as Do Not Resuscitate, unless it is anticipated within a reasonable degree of medical certainty that they can achieve benefit from potentially curative antibiotic therapy * Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents

Outcome results

None listed