Format

Send to

Choose Destination
Int J Infect Dis. 2015 Jan;30:67-73. doi: 10.1016/j.ijid.2014.10.009. Epub 2014 Oct 30.

A randomized phase 2 study comparing two doses of delafloxacin with tigecycline in adults with complicated skin and skin-structure infections.

Author information

1
eStudySite, 6367 Alvarado Court, Suite 300, San Diego, CA 92120, USA. Electronic address: woriordan@estudysite.com.
2
Artemis Research Group, 770 Washington Street, Suite 300, San Diego, CA 92103, USA.
3
eStudySite, 6367 Alvarado Court, Suite 300, San Diego, CA 92120, USA.
4
Southeast Regional Research Group, 5210 Armour Road, Suite 300, Columbus, GA 31904, USA.
5
Melinta Therapeutics, Inc., 300 George Street, Suite 301, New Haven, CT 06511, USA.

Abstract

BACKGROUND:

A randomized, double-blind, multicenter trial was done to compare two doses of delafloxacin with tigecycline in patients with various complicated skin and skin-structure infections (wound infections following surgery, trauma, burns, or animal/insect bites, abscesses, and cellulitis).

METHODS:

Patients were randomized 1:1:1 to receive delafloxacin 300mg intravenous (IV) every 12h, delafloxacin 450mg IV every 12h, or tigecycline 100mg IV×1, followed by 50mg IV every 12h; randomization was stratified by infection type. Duration of therapy was 5-14 days. The primary efficacy analysis, performed on the clinically evaluable (CE) population at the test-of-cure (TOC) visit (14-21 days after the final dose of study drug), compared clinical response rates in the delafloxacin and tigecycline arms. Clinical response rates in the two delafloxacin arms were also compared.

RESULTS:

Among CE patients, clinical cure rates at TOC visit were similar in the delafloxacin and tigecycline arms (94.3%, 92.5%, and 91.2%, respectively in delafloxacin 300-mg, delafloxacin 450-mg, and tigecycline arms). Overall, the most frequent adverse events were nausea, vomiting, and diarrhea; the 300-mg delafloxacin arm was the best-tolerated regimen.

CONCLUSIONS:

Delafloxacin was similarly effective as tigecycline for a variety of complicated skin and skin-structure infections and was well tolerated. (Clinicaltrials.gov NCT 0719810).

KEYWORDS:

ABSSSIs; Delafloxacin; MRSA; MSSA; Polymicrobial skin infections

PMID:
25448332
DOI:
10.1016/j.ijid.2014.10.009
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center