A Phase 2 Randomized, Double-blind, Double-dummy Efficacy, Safety And Tolerability Study Of Iv Sulopenem With Switch To Oral Pf-03709270 Compared To Ceftriaxone With Step Down To Amoxicillin/Clavulanate Potassium (Augmentin) In Subjects With Community Acquired Pneumonia (Cap) Requiring Hospitalization

NCT00797108 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Pfizer
Phase	Phase 2
Status	COMPLETED
Enrolment	35
Start date	2009-01
Completion	2009-06

Conditions

• Pneumonia, Bacterial

Interventions

• sulopenem and PF-03709270
• Sulopenem and PF-03709270
• Ceftriaxone and amoxicillin/clavulanate

Primary outcomes

• Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit — 7 to 14 days after end of treatment
  Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At TOC (7 to 14 days after end of treatment \[EOT\]) CR was evaluated as "cure"=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; "failure"=persistence or progression of baseline signs and symptoms of pneumonia (for example: body temperature, white blood cell \[WBC\] count, respiratory rate, auscultatory findings, cough, sputum production), development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; "indeterminate"=extenuating circumstances precluded classification to 1 of the above.

Countries

United States, Australia, Canada, Poland, South Korea