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

Highlights • Complicated skin and skin-structure infections (cSSSIs) may require surgery. • A study of the efficacy and safety of two doses of delafloxacin vs. tigecycline in cSSSIs was performed. • Patients were randomized by infection type: abscess, wound infection, or cellulitis. • Both delafloxa...

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Published in	International journal of infectious diseases Vol. 30; no. C; pp. 67 - 73
Main Authors	O’Riordan, William, Mehra, Purvi, Manos, Paul, Kingsley, Jeff, Lawrence, Laura, Cammarata, Sue
Format	Journal Article
Language	English
Published	Canada Elsevier Ltd 01.01.2015 Elsevier
Subjects	Abscess - drug therapy ABSSSIs Adolescent Adult Aged Aged, 80 and over Anti-Bacterial Agents - administration & dosage Anti-Bacterial Agents - adverse effects Anti-Bacterial Agents - therapeutic use Cellulitis - drug therapy Delafloxacin Double-Blind Method Female Fluoroquinolones - administration & dosage Fluoroquinolones - adverse effects Fluoroquinolones - therapeutic use Humans Infectious Disease Male Middle Aged Minocycline - analogs & derivatives Minocycline - therapeutic use MRSA MSSA Polymicrobial skin infections Pulmonary/Respiratory Wound Infection - drug therapy Young Adult MSSA ABSSSIs Delafloxacin Polymicrobial skin infections MRSA
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Abstract	Highlights • Complicated skin and skin-structure infections (cSSSIs) may require surgery. • A study of the efficacy and safety of two doses of delafloxacin vs. tigecycline in cSSSIs was performed. • Patients were randomized by infection type: abscess, wound infection, or cellulitis. • Both delafloxacin and tigecycline had cure rates >90% for all pathogens/infections. • Delafloxacin was well tolerated at a dose of 300 mg intravenous every 12 h.
AbstractList	Highlights • Complicated skin and skin-structure infections (cSSSIs) may require surgery. • A study of the efficacy and safety of two doses of delafloxacin vs. tigecycline in cSSSIs was performed. • Patients were randomized by infection type: abscess, wound infection, or cellulitis. • Both delafloxacin and tigecycline had cure rates >90% for all pathogens/infections. • Delafloxacin was well tolerated at a dose of 300 mg intravenous every 12 h. 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). 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. 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. Delafloxacin was similarly effective as tigecycline for a variety of complicated skin and skin-structure infections and was well tolerated. (Clinicaltrials.gov NCT 0719810). BACKGROUNDA 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).METHODSPatients 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.RESULTSAmong 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.CONCLUSIONSDelafloxacin was similarly effective as tigecycline for a variety of complicated skin and skin-structure infections and was well tolerated. (Clinicaltrials.gov NCT 0719810). 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 300 mg intravenous (IV) every 12 h, delafloxacin 450 mg IV every 12 h, or tigecycline 100 mg IV × 1, followed by 50 mg IV every 12 h; 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) •Complicated skin and skin-structure infections (cSSSIs) may require surgery.•A study of the efficacy and safety of two doses of delafloxacin vs. tigecycline in cSSSIs was performed.•Patients were randomized by infection type: abscess, wound infection, or cellulitis.•Both delafloxacin and tigecycline had cure rates >90% for all pathogens/infections.•Delafloxacin was well tolerated at a dose of 300mg intravenous every 12h. 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). 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. 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. Delafloxacin was similarly effective as tigecycline for a variety of complicated skin and skin-structure infections and was well tolerated. (Clinicaltrials.gov NCT 0719810)
Author	Manos, Paul Cammarata, Sue Lawrence, Laura Kingsley, Jeff O’Riordan, William Mehra, Purvi
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Snippet	Highlights • Complicated skin and skin-structure infections (cSSSIs) may require surgery. • A study of the efficacy and safety of two doses of delafloxacin vs.... •Complicated skin and skin-structure infections (cSSSIs) may require surgery.•A study of the efficacy and safety of two doses of delafloxacin vs. tigecycline... A randomized, double-blind, multicenter trial was done to compare two doses of delafloxacin with tigecycline in patients with various complicated skin and... BACKGROUNDA randomized, double-blind, multicenter trial was done to compare two doses of delafloxacin with tigecycline in patients with various complicated... Background: A randomized, double-blind, multicenter trial was done to compare two doses of delafloxacin with tigecycline in patients with various complicated...
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SubjectTerms	Abscess - drug therapy ABSSSIs Adolescent Adult Aged Aged, 80 and over Anti-Bacterial Agents - administration & dosage Anti-Bacterial Agents - adverse effects Anti-Bacterial Agents - therapeutic use Cellulitis - drug therapy Delafloxacin Double-Blind Method Female Fluoroquinolones - administration & dosage Fluoroquinolones - adverse effects Fluoroquinolones - therapeutic use Humans Infectious Disease Male Middle Aged Minocycline - analogs & derivatives Minocycline - therapeutic use MRSA MSSA Polymicrobial skin infections Pulmonary/Respiratory Wound Infection - drug therapy Young Adult
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Title	A randomized phase 2 study comparing two doses of delafloxacin with tigecycline in adults with complicated skin and skin-structure infections
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