Phase 2
N=35
A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization
Pneumonia, Bacterial
Bottom Line
View on ClinicalTrials.gov: NCT00797108 ↗Enrolled (actual)
35
Serious AEs
12.1%
Results posted
Mar 2016
Primary outcome: Primary: Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit — 90.0; 87.5; 62.5; 10.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sulopenem and PF-03709270 (Drug); Ceftriaxone and amoxicillin/clavulanate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit |
90.0; 87.5; 62.5; 10.0; 12.5; 25.0 | — |
| SECONDARY Percentage of Participants With Clinical Response at End of Treatment (EOT) and Follow-up Visit |
60.0; 75.0; 75.0; 30.0; 25.0; 12.5 | — |
| SECONDARY Number of Participants With Microbiological Response at Test of Cure (TOC) Visit |
4; 4; 3; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Community Acquired Pneumonia (CAP) Symptom Questionnaire at Test of Cure (TOC) and Follow-up Visit |
2.17; 2.75; 2.57; -1.43; -2.02; -1.74 | — |
Summary
The purpose of this study is to test if intravenous sulopenem and an oral drug, PF-03709270 are safe and effective in patients that are hospitalized with community acquired pneumonia.
Eligibility Criteria
Inclusion Criteria
- Hospitalized male or female patients 18 years of age or older.
- Female patients of childbearing potential must not be pregnant.
- Must exhibit at least two pre-specified clinical symptoms/signs of pneumonia.
- Must require hospitalization for the pneumonia.
- Chest Xray must be suggestive of a pneumonia.
Exclusion Criteria
- Hospital or ventilator associated pneumonia.
- Patients with cystic fibrosis, pneumocystis carinii pneumonia or active tuberculosis.
- Previous treatment for the current pneumonia episode received for more than 24 hours.
- Allergies to penems or beta lactams.
Data sourced from ClinicalTrials.gov (NCT00797108). 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.