Phase II Study of Oral Nafithromycin in CABP

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 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 Overview

• Status: Completed
• Conditions: Community-Acquired Bacterial Pneumonia (CABP)
• Intervention / Treatment: Drug: Nafithromycin 800 mg 3 days; Drug: Nafithromycin 800 mg 5 days; Drug: Moxifloxacin 400 mg

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • A & L Clinical research
    • Miami, Florida, United States, 33144
      • A Plus Research Inc.
    • Miami, Florida, United States, 33175
      • RM Medical Research, Inc.
    • Miami Lakes, Florida, United States, 33016
      • Empire Clinical Research, LLC
  • Massachusetts
    • Bedford, Massachusetts, United States, 02740-6634
      • HCI Metromedic Walkin Medical Center
  • South Dakota
    • Bedford, South Dakota, United States, 57702
      • Health Concepts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nafithromycin 800 mg 3 days; PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind	Drug: Nafithromycin 800 mg 3 days
Experimental: Nafithromycin 800 mg 5 days; PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind	Drug: Nafithromycin 800 mg 5 days
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	Drug: Moxifloxacin 400 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response in the ITT Population	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	Day 4 from start of drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response in the Micro-ITT Population	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	Day 4 from start of drug administration

Collaborators and Investigators

• Sponsor: Wockhardt
• Collaborators: ACM
• Investigators: Study Director: Ashima Bhatia, MD PDCR, Wockhardt

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 8, 2017

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 19, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Pneumonia, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Moxifloxacin; Nafithromycin
• Other Study ID Numbers: W-4873-201