1153. Comparison of Delafloxacin (DLX) and Vancomycin (VAN) by Age and Gender in Two Phase 3 Trials in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSIs)
Session: Poster Abstract Session: Clinical Infectious Diseases: Bone and Joint, Skin and Soft Tissue
Friday, October 28, 2016
Room: Poster Hall
Posters
  • IDWeek 2016 age gender FINAL.10.6.pdf (346.7 kB)
  • Background: DLX is a novel investigational anionic fluoroquinolone being developed for oral or intravenous (IV) administration for infections caused by Gram‑positive organisms (including methicillin-resistant Staphylococcus aureus [MRSA]), Gram‑negative organisms, atypical organisms, and anaerobes.

    Methods: Data on age and gender were reviewed from 2 randomized, double-blind trials of adults with ABSSSI. At baseline, patients had a lesion size ≥75 cm2 with ≥ 2 signs of systemic infection. Patients received 5–14 days BID DLX 300 mg IV/ 450mg Oral, or VAN 15 mg/kg (based on the actual body weight) with aztreonam (AZ). Both studies included endpoints for objective response at 48-72 hrs based on ≥20% reduction of lesion size and investigator‑assessed response rates based on complete resolution of signs and symptoms (Cure) at Follow up (FU; Day 14) and Late Follow up (LFU; Day 21-28).

    Results: In the combined patient pool, 1,510 patients (754 DLX, 756 VAN) in the Intent to Treat (ITT) had a mean age of 49.0 yrs for DLX and 48.1 yrs for VAN (1,314 were <65 yrs, 196 >65 yrs), and were majority male (62% DLX, 64% VAN). At baseline, digital mean lesion size was similar between both arms (321.1 cm2 DLX, 344.7 cm2 VAN).  Infection types included cellulitis (44.0%), wound infection (30.1%), major cutaneous abscess (25.1%) and burn infection (0.8%). Below is the comparison of DLX and VAN objective response at 48-72 hours in the ITT population:

    Patient Population

    DLX

    VAN + AZ

    Diff [95% CI]

    Overall

    n/N (%)

    613/754 (81.3)

    610/756 (80.7)

    0.8 (-3.2, 4.7)

    Age

    n/N (%)

    ≤65

    538/653 (82.4)

    543/661 (82.1)

    0.4 (-3.7, 4.5)

    >65

    75/101 (74.3)

    67/95 (70.5)

    4.3 (-8.1, 16.6)

    Gender

    n/N (%)

    Male

    381/468 (81.4)

    397/485 (81.9)

    -0.1 (-5.1, 4.8)

    Female

    232/286 (81.1)

    213/271 (78.6)

    2.6 (-4.2, 9.3)

    Investigator-assessed cure rates for all subjects at FU (55.2% DLX, 55.7% VAN) and LFU (69.0% DLX, 69.0% VAN) were similar. Overall, DLX had similar rates of related TEAEs between treatment groups regardless of age and gender. The most common AEs that were related to treatment were nausea (6.1% DLX, 4.3% VAN), pruritus (0.4% DLX, 2.3% VAN), and diarrhea (6.1% DLX, 2.0% VAN).

    Conclusion: In a pooled analysis based on age and gender, DLX had comparable outcomes to VAN for the objective response at 48-72 hours. DLX was also well tolerated regardless of age or gender.

    Eric Hansen, MD1, Sergiu Ungureanu, MD2, Borislav Ninov Sr., MD, PhD3, Oscar Pamo Reyna, MD4, Megan Quintas, BS5, Laura Lawrence, B.S.5 and Sue K. Cammarata, M.D.5, (1)South Jersey Infectious Disease, Somers Point, NJ, (2)Department of General Surgery, Republican Clinical Hospital, Chisinau, Moldova, The Republic of, (3)Second Surgery Clinic, University Multiprofile Hospital for Active Treatment, Pleven, Bulgaria, (4)Hospital Arzobispo Loayza, Lima, Peru, (5)Melinta Therapeutics, Inc., New Haven, CT

    Disclosures:

    E. Hansen, Melinta Therapeutics: Investigator , Research support

    S. Ungureanu, Melinta Therapeutics: Investigator , Research support

    B. Ninov Sr., Melinta Therapeutics: Investigator , Research support

    O. Pamo Reyna, Melinta Therapeutics: Investigator , Research support

    M. Quintas, Melinta Therapeutics, Inc.: Employee , Salary

    L. Lawrence, Melinta Therapeutics, Inc.: Employee , Salary

    S. K. Cammarata, Melinta Therapeutics: Employee , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. CDT, Wednesday Oct. 26th with the exception of research findings presented at the IDWeek press conferences.