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Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia (SOLITAIRE-IV)

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ClinicalTrials.gov Identifier: NCT01968733
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE October 21, 2013
First Posted Date  ICMJE October 24, 2013
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE November 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2013)
Early clinical response rate in the Intent to Treat (ITT) population. [ Time Frame: 72 [±12] hours after the first dose of study drug ]
To determine noninferiority (NI) in early clinical response rate, in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2013)
  • Early clinical response rate in the microITT population [ Time Frame: 72 [±12] hours after the first dose of study drug ]
    To determine NI in early clinical response rate of intravenous to oral solithromycin compared to intravenous to oral moxifloxacin in the mITT population
  • Clinical success rates in the ITT and Clinically Evaluable (CE) populations [ Time Frame: 5 to 10 days after the last dose of study drug ]
    To determine the overall clinical success rates of intravenous to oral solithromycin compared to moxifloxacin
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
Official Title  ICMJE A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia
Brief Summary This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.
Detailed Description Community-acquired bacterial pneumonia (CABP) is an acute infection of the pulmonary parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or dyspnea. The widespread emergence of antibiotic resistant pathogens, including the macrolide-resistant Streptococcus pneumoniae, has resulted in a need for new and effective antibiotics that have activity against CABP pathogens. Solithromycin is a fourth generation macrolide antibiotic with excellent activity against resistant S. pneumoniae and other key typical and atypical bacterial respiratory pathogens. A completed Phase 2 study showed comparable efficacy to levofloxacin in adults with CABP.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Community-acquired Bacterial Pneumonia
Intervention  ICMJE
  • Drug: Solithromycin
    Other Name: CEM-101
  • Drug: Moxifloxacin
    Other Name: Avelox
Study Arms  ICMJE
  • Active Comparator: Moxifloxacin
    Intravenous with the potential step-down to oral moxifloxacin
    Intervention: Drug: Moxifloxacin
  • Experimental: Solithromycin
    Intravenous with potential step-down to oral solithromycin
    Intervention: Drug: Solithromycin
Publications * File TM Jr, Rewerska B, Vucinic-Mihailovic V, Gonong JRV, Das AF, Keedy K, Taylor D, Sheets A, Fernandes P, Oldach D, Jamieson BD. SOLITAIRE-IV: A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous-to-Oral Solithromycin to Intravenous-to-Oral Moxifloxacin for Treatment of Community-Acquired Bacterial Pneumonia. Clin Infect Dis. 2016 Oct 15;63(8):1007-1016. doi: 10.1093/cid/ciw490. Epub 2016 Jul 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2015)
863
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2013)
860
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female patients ≥ 18 years of age
  • An acute onset of at least 3 of the following signs and symptoms (new or worsening):

    1. Cough
    2. Production of purulent sputum
    3. Shortness of breath (dyspnea)
    4. Chest pain due to pneumonia
  • At least 1 of the following:

    1. Fever
    2. Hypothermia
    3. Presence of pulmonary rales and/or evidence of pulmonary consolidation
  • PORT Risk Class II, III, or IV
  • Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study
  • Not received any systemic antibiotics during the prior 7 days

Exclusion Criteria:

  • Ventilator-associated pneumonia
  • Known anatomical or pathological bronchial obstruction or a history of bronchiectasis or documented severe chronic obstructive pulmonary disease
  • Hospitalization within 90 days or residence in a long-term care facility within 30 days prior to the onset of symptoms
  • Fungal pneumonia
  • Pneumocystis jiroveci pneumonia
  • Aspiration pneumonia
  • Other non-infectious causes of pulmonary infiltrates
  • Primary or metastatic lung cancer
  • Cystic fibrosis
  • Active or suspected tuberculosis
  • HIV or myasthenia gravis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Canada,   Chile,   Colombia,   Georgia,   Germany,   Guatemala,   Hungary,   Korea, Republic of,   Latvia,   Malaysia,   Netherlands,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   South Africa,   Spain,   Taiwan,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01968733
Other Study ID Numbers  ICMJE CE01-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Melinta Therapeutics, Inc.
Study Sponsor  ICMJE Melinta Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Brian D Jamieson, MD Melinta Therapeutics, Inc.
PRS Account Melinta Therapeutics, Inc.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP