Phase II Study of Oral Nafithromycin in CABP
Completed · Phase 2
Conditions studied: Community-Acquired Bacterial Pneumonia (CABP)
In brief
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
Key facts
- Study ID
- NCT02903836
- Run by
- Wockhardt
- People needed
- 231
- Starts
- 2016-11-18
- Expected to finish
- 2017-07-08
- Last updated by the study team
- 2019-12-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- 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
Full record on ClinicalTrials.gov
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