Phase 2
Completed N=224
Phase II Study of Oral Nafithromycin in CABP
Community-Acquired Bacterial Pneumonia (CABP)
Source: ClinicalTrials.gov NCT02903836 ↗
Enrolled (actual)
224
Serious AEs
1.8%
Results posted
Dec 2019
Primary outcomePrimary: Clinical Response in the ITT Population — 68; 65; 67 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response in the ITT Population |
68; 65; 67 | — |
| SECONDARY Clinical Response in the Micro-ITT Population |
21; 26; 18 | — |
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
Data sourced from ClinicalTrials.gov (NCT02903836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.