1538. Evaluation of Health-Related Quality of Life (HRQL) in ABSSSI Patients after Antibiotic Discontinuation in a Phase 3 Trial
Session: Poster Abstract Session: Clinical Infectious Diseases: Soft Tissue Infections (ABSSSIs)
Saturday, October 10, 2015
Room: Poster Hall
Posters
  • 2015 IDWeek HRQL_FINAL.pdf (749.1 kB)
  • Background:

    Limited HRQL data exists for pa­tients with ABSSSI.  This analysis evaluates HRQL in patients with a positive clinical response (cured, complete resolu­tion of all baseline signs and symptoms OR improved, some symptoms remain but no further antibiotics are necessary) in patients enrolled in an ABSSSI phase 3 trial.

    Methods:  

    Adult patients diagnosed with ABSSSI were enrolled in a prospective phase 3, randomized, double-blind study to evaluate antibiotic treatment.  Investigators were asked to assess patients with a positive clinical response as cured or improved at the End of Treatment (EOT), followup (FU, study day 14±1) and late follow up (LFU, study day 21-28). An analysis was conducted to understand the difference between cured and improved patients with respect patient reported HRQL as measured by Extremity Soft Tissue Infection (ESTI) Score, a 20 question survey with a 5 point Likert scale (5 is the highest degree of importance/impairment to patients) measured symptoms, daily functioning, emotional functioning, and social interactions.

    Results:

    660 patients were enrolled in this study and 589 patients had data for inclusion in this analysis.  Overall, improved patients had more difficulties with HRQL measures than cured patients.  Approximately 20% of the improved patients at EOT did not proceed to cure by LFU.  The ESTI Score was statistically higher at LFU in improved patients than cured. At LFU improved patients were more likely than cured patients to report having continued difficulty performing a job and earning an income.  Obese patients, who comprised 29% of the patients in the study, reported even greater difficult with HRQL measures.  Results for patients at LFU shown below.

     

    BMI >=30 kg/m²

    BMI <30 kg/m²

     

    Cured
    (N = 140)

    Improved
    (N=31)

    p-value

    Cured 
    (N = 312)

    Improved
    (N=49)

    p-value

    Mean Overall ESTI Score  

    26.3 

    46.4 

    0.0289

    25.5

    35.7

    0.1305

        % Reporting difficulty

     

     

     

                   Doing a job

    9.6%

    29.0%

    0.0075

    8.4%

    27.1%

    0.0006

                   Earning an income

    14.0%

    32.3%

    0.0320

    9.4%

    27.1%

    .0013

    Conclusion:

    Patients who were improved when the physician stopped antibiotics at EOT had more difficulty than cured patients with HRQL measures at LFU.  Improved patients, particularly those who are obese, may have persistent HRQL issues that require further utilization of health care resources. Additional research is needed to determine the potential economic impact of this data.

    Ralph Corey, MD, Duke University Medical Center, Durham, NC, Kalpana Gupta, MD, MPH, Department of Medicine/Boston University School of Medicine, Boston, MA, Eugnenia Henry, PhD, H2O Clinical LLC, Hunt Valley, MD, Emily Mcginnis, MPH, Melinta Therapeutics, Lincolnshire, IL and Sue Cammarata, MD, Melinta Therapeutics, New Haven, CT

    Disclosures:

    R. Corey, Melinta Therapeutics: Consultant , Consulting fee

    K. Gupta, Melinta Therapeutics: Consultant , Consulting fee

    E. Henry, Melinta Therapeutics: Consultant , Consulting fee

    E. Mcginnis, Melinta Therapeutics: Employee , Salary

    S. Cammarata, Melinta Therapeutics: Employee , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 7th with the exception of research findings presented at the IDWeek press conferences.