Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
231 participants
INTERVENTIONAL
2016-11-18
2017-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Nafithromycin 800 mg 3 days
PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind
Nafithromycin 800 mg 3 days
Nafithromycin 800 mg 5 days
PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind
Nafithromycin 800 mg 5 days
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
Moxifloxacin 400 mg
Interventions
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Nafithromycin 800 mg 3 days
Nafithromycin 800 mg 5 days
Moxifloxacin 400 mg
Eligibility Criteria
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Inclusion Criteria
1. Clinical symptoms (new or worsening)
2. Vital sign abnormalities
3. Laboratory abnormalities
4. Radiographic evidence of CABP
5. PORT score
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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ACM
UNKNOWN
Wockhardt
INDUSTRY
Responsible Party
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Principal Investigators
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Ashima Bhatia, MD PDCR
Role: STUDY_DIRECTOR
Wockhardt
Locations
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A & L Clinical research
Miami, Florida, United States
A Plus Research Inc.
Miami, Florida, United States
RM Medical Research, Inc.
Miami, Florida, United States
Empire Clinical Research, LLC
Miami Lakes, Florida, United States
HCI Metromedic Walkin Medical Center
Bedford, Massachusetts, United States
Health Concepts
Bedford, South Dakota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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W-4873-201
Identifier Type: -
Identifier Source: org_study_id