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Phase II Study of Oral Nafithromycin in CABP

Primary Purpose

Community-Acquired Bacterial Pneumonia (CABP)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nafithromycin 800 mg 3 days
Nafithromycin 800 mg 5 days
Moxifloxacin 400 mg
Sponsored by
Wockhardt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-Acquired Bacterial Pneumonia (CABP)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Empire Clinical Research, LLC
  • A & L Clinical research
  • A Plus Research Inc.
  • RM Medical Research, Inc.
  • HCI Metromedic Walkin Medical Center
  • Health Concepts

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Nafithromycin 800 mg 3 days

Nafithromycin 800 mg 5 days

Moxifloxacin 400 mg

Arm Description

PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind

PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2016
Last Updated
December 19, 2019
Sponsor
Wockhardt
Collaborators
ACM
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1. Study Identification

Unique Protocol Identification Number
NCT02903836
Brief Title
Phase II Study of Oral Nafithromycin in CABP
Official Title
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
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 18, 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wockhardt
Collaborators
ACM

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-Acquired Bacterial Pneumonia (CABP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nafithromycin 800 mg 3 days
Arm Type
Experimental
Arm Description
PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind
Arm Title
Nafithromycin 800 mg 5 days
Arm Type
Experimental
Arm Description
PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind
Arm Title
Moxifloxacin 400 mg
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Nafithromycin 800 mg 3 days
Intervention Type
Drug
Intervention Name(s)
Nafithromycin 800 mg 5 days
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin 400 mg
Primary Outcome Measure Information:
Title
Clinical Response in the ITT Population
Description
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
Time Frame
Day 4 from start of drug administration
Secondary Outcome Measure Information:
Title
Clinical Response in the Micro-ITT Population
Description
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
Time Frame
Day 4 from start of drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet the clinical criteria for CABP based on following: Clinical symptoms (new or worsening) Vital sign abnormalities Laboratory abnormalities Radiographic evidence of CABP PORT score Exclusion Criteria: Subjects with any of the following confirmed or suspected types of pneumonia: Aspiration pneumonia Hospital-acquired bacterial pneumonia (HABP) Healthcare-associated bacterial pneumonia (HCAP) Ventilator-associated bacterial pneumonia (VABP) Pneumonia that may be caused by pathogen(s) resistant to either study drug Receipt of 1 or more dose(s) of a potentially effective systemic antibacterial treatment for treatment of the current CABP Suspected or confirmed non-infectious causes of pulmonary infiltrates Subjects requiring concomitant adjunctive or additional potentially-effective systemic antibacterial treatment for management of CABP
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashima Bhatia, MD PDCR
Organizational Affiliation
Wockhardt
Official's Role
Study Director
Facility Information:
Facility Name
Empire Clinical Research, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
A & L Clinical research
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
A Plus Research Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
RM Medical Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
HCI Metromedic Walkin Medical Center
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740-6634
Country
United States
Facility Name
Health Concepts
City
Bedford
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase II Study of Oral Nafithromycin in CABP

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