Phase II Study of Oral Nafithromycin in CABP

Overview

Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults

Full Title of Study: “A Phase II, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2017

Interventions

  • Drug: Nafithromycin 800 mg 3 days
  • Drug: Nafithromycin 800 mg 5 days
  • Drug: Moxifloxacin 400 mg

Arms, Groups and Cohorts

  • Experimental: Nafithromycin 800 mg 3 days
    • PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind
  • Experimental: Nafithromycin 800 mg 5 days
    • PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind
  • Active Comparator: Moxifloxacin 400 mg
    • PO q24h for 7 days;subjects will also receive two nafithromycin placebo tablets PO q24h on Days 1 through Day 7 to maintain the blind

Clinical Trial Outcome Measures

Primary Measures

  • Clinical Response in the ITT Population
    • Time Frame: Day 4 from start of drug administration
    • The primary efficacy endpoint was clinical response (response, non-response, or indeterminate) at Day 4, tested in the ITT population. Clinical response was determined programmatically using the investigator’s assessment of CABP symptoms entered into the eCRF. The severity of the subject CABP symptoms of dyspnea (shortness of breath), cough, production of purulent sputum, and pleuritic chest pain were evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Symptom Severity Guidance

Secondary Measures

  • Clinical Response in the Micro-ITT Population
    • Time Frame: Day 4 from start of drug administration
    • Clinical response (response, non-response, or indeterminate) at Day 4 was also tested in the micro-ITT population as a secondary efficacy endpoint. Clinical response was determined programmatically using the investigator’s assessment of CABP symptoms entered into the eCRF. The severity of the subject CABP symptoms of dyspnea (shortness of breath), cough, production of purulent sputum, and pleuritic chest pain were evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Symptom Severity Guidance

Participating in This Clinical Trial

Inclusion Criteria

Meet the clinical criteria for CABP based on following: 1. Clinical symptoms (new or worsening) 2. Vital sign abnormalities 3. Laboratory abnormalities 4. Radiographic evidence of CABP 5. PORT score Exclusion Criteria:

1. Subjects with any of the following confirmed or suspected types of pneumonia: 1. Aspiration pneumonia 2. Hospital-acquired bacterial pneumonia (HABP) 3. Healthcare-associated bacterial pneumonia (HCAP) 4. Ventilator-associated bacterial pneumonia (VABP) 5. Pneumonia that may be caused by pathogen(s) resistant to either study drug 2. Receipt of 1 or more dose(s) of a potentially effective systemic antibacterial treatment for treatment of the current CABP 3. Suspected or confirmed non-infectious causes of pulmonary infiltrates 4. Subjects requiring concomitant adjunctive or additional potentially-effective systemic antibacterial treatment for management of CABP

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wockhardt
  • Collaborator
    • ACM
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ashima Bhatia, MD PDCR, Study Director, Wockhardt

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