NCT02903836

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 18, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2017

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

December 20, 2019

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

8 months

First QC Date

September 13, 2016

Results QC Date

February 27, 2019

Last Update Submit

December 19, 2019

Conditions

Community-Acquired Bacterial Pneumonia (CABP)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Clinical Response in the Micro-ITT Population

    Day 4 from start of drug administration

Study Arms (3)

Nafithromycin 800 mg 3 days

EXPERIMENTAL

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

Drug: Nafithromycin 800 mg 3 days

Nafithromycin 800 mg 5 days

EXPERIMENTAL

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

Drug: Nafithromycin 800 mg 5 days

Moxifloxacin 400 mg

ACTIVE COMPARATOR

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

Interventions

Nafithromycin 800 mg 3 daysDRUG
Nafithromycin 800 mg 3 days
Nafithromycin 800 mg 5 daysDRUG
Nafithromycin 800 mg 5 days
Moxifloxacin 400 mgDRUG
Moxifloxacin 400 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

A & L Clinical research

Miami, Florida, 33126, United States

Location

A Plus Research Inc.

Miami, Florida, 33144, United States

Location

RM Medical Research, Inc.

Miami, Florida, 33175, United States

Location

Empire Clinical Research, LLC

Miami Lakes, Florida, 33016, United States

Location

HCI Metromedic Walkin Medical Center

Bedford, Massachusetts, 02740-6634, United States

Location

Health Concepts

Bedford, South Dakota, 57702, United States

Location

MeSH Terms

Interventions

nafithromycinMoxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr Manishkumar D Shah
Organization
Wockhardt
manish.shah@wockhardt.com
02226534444

Study Officials

  • Ashima Bhatia, MD PDCR

    Wockhardt

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 16, 2016

Study Start

November 18, 2016

Primary Completion

July 1, 2017

Study Completion

July 8, 2017

Last Updated

December 20, 2019

Results First Posted

December 20, 2019

Record last verified: 2019-12

Locations

US(6)