893. Characterization of Mycoplasma pneumoniae Infection and Outcomes in the SOLITAIRE-Oral, Global Phase 3 Clinical Trial for Solithromycin
Session: Poster Abstract Session: Clinical Trials
Friday, October 9, 2015
Room: Poster Hall
Posters
  • Mpn in the SOLITAIRE-Oral Trial_Cempra_October 2015.pdf (1.1 MB)
  • Background: Solithromycin is a 4th generation macrolide antibiotic with potent activity against typical and atypical pathogens that cause community acquired bacterial pneumonia (CABP), including ‘macrolide-resistant' pneumococci and Mycoplasma pneumoniae (Mpn). In SOLITAIRE-Oral, a global Phase 3 clinical trial, a 5-day course of oral solithromycin was demonstrated to be non-inferior to a 7-day course of oral moxifloxacin for treatment of community acquired bacterial pneumonia (CABP) among adult patients with PORT II-IV disease.  

    Methods: Patients with acute onset of radiographically confirmed CABP with consistent signs and symptoms were eligible.  Mycoplasma transport media was inoculated with oropharyngeal swabs obtained at baseline and immediately frozen. Mpn was detected by culture and/or quantitative PCR.  Acute and convalescent serum samples were assayed for diagnostic Mpn-IgG response (≥4-fold rise to a titer ≥1:160). Treatment efficacy was assessed on Day 4 (Early Clinical Response) and in follow-up (5-10 days following end of therapy).

    Results: 860 patients with CABP were enrolled from sites in 16 countries, and a microbiological diagnosis (all pathogens) was established in 53.6% of patients.  Mpn infection was diagnosed in 9.2% of all enrolled patients. Mpn was detected throughout the year, at overall rates by region ranging from 5.9% in South Africa to 10.9% in Europe. The mean age of Mpn patients was 52.9 (range 18-87), versus 57.6 (18-93) for non-Mpn patients. The mean baseline PSI score for Mpn patients was 68.9 (range 52-102) versus 71.4 (48-112).  44.3% of patients with Mpn had other CABP pathogen(s) identified. Mpn isolates (N=26) were highly susceptible to solithromycin (MIC90 ≤0.000032 µg/mL) in comparison with moxifloxacin (MIC90 0.125 µg/mL). 83.8% of patients treated with solithromycin had an early clinical response versus 78.6% of those treated with moxifloxacin. Clinical success rates at the test of cure visit 5-10 days after treatment were comparable (89.2% vs. 90.5%).

    Conclusion: Mpn is a significant, global etiologic agent of CABP, causing moderate to severe disease in adults of all ages. Mpn pneumonia was effectively treated by solithromycin. 

     

    David Oldach, MD, FIDSA1, Hristo Metev, MD2, Analia Mykietiuk, MD3, Cristina Mihaela Tanaseanu, MD4, Anita Das, PhD5, Brian Jamieson, MD1, Kay Clark, RN1, Amanda Sheets, PhD1, Kara Keedy, PhD1, Donna Crabb, MT(ASCP)6, Amy Ratliff, MLS (ASCP)6, Ken Waites, MD7,8 and Prabhavathi Fernandes, PhD1, (1)Cempra Pharmaceuticals, Inc, Chapel Hill, NC, (2)Dr. Dimitar Gramatikov Hospital for Pulmonary Diseases, Rousse, Bulgaria, (3)Instiuto Medico Platense, La Plata, Buenos Aires, Argentina, (4)St. Pantelimon Emergency Clinical Hospital, Bucharest, Romania, (5)Das Consulting, San Mateo, CA, (6)University of Alabama at Birmingham, Diagnostic Mycoplasma Laboratory, Birmingham, AL, (7)University of Alabama at Birmingham, Birmingham, AL, (8)University of Alabama at Birmingham, Diagnostic Myoplasma Laboratory, Birmingham, AL

    Disclosures:

    D. Oldach, Cempra Inc: Employee and Shareholder , Salary

    H. Metev, Cempra, Inc.: Investigator , Institution Received Payment for Their Role in Execution of this Phase 3 Trial

    A. Mykietiuk, Cempra, Inc: Investigator , Institution Received Payment for Their Role in Execution of this Phase 3 Trial

    C. Mihaela Tanaseanu, Cempra Inc: Investigator , Institution Received Payment for Their Role in Execution of this Phase 3 Trial

    A. Das, Cempra Inc: Consultant , Consulting fee

    B. Jamieson, Cempra: Employee and Shareholder , Salary

    K. Clark, Cempra Inc: Employee and Shareholder , Salary

    A. Sheets, Cempra Inc: Employee and Shareholder , Salary

    K. Keedy, Cempra Inc: Employee and Shareholder , Salary

    D. Crabb, Cempra, Inc.: Research Contractor , Laboratory was compensated for processing and analysis of clinical trial specimens

    A. Ratliff, Cempra, Inc.: Research Contractor , Laboratory was compensated for processing and analysis of clinical trial specimens

    K. Waites, Cempra, Inc.: Research Contractor , Laboratory was compensated for processing and analysis of clinical trial specimens

    P. Fernandes, Cempra Inc: Board Member , Employee and Shareholder , Salary

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