CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
sulopenem and PF-03709270 +2 moredrug
Likely dose
sulopenem and PF-03709270 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00797108
NCT00797108Phase 2Completed
CompareCT.gov

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

Pfizer·interventional·Posted Nov 25, 2008·Updated Mar 10, 2016

In Brief

A Phase 2 clinical trial evaluating sulopenem and PF-03709270, Sulopenem and PF-03709270, and 1 other intervention for Pneumonia, Bacterial. Completed, enrolled 35 participants across 24 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumonia, Bacterial
CountriesAustralia, Canada, Poland, South Korea, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 25, 2008
Enrollment StartJan 1, 2009
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.6 years ago

Interventions

sulopenem and PF-03709270drug

Sulopenem - 600 mg infused over 1 hour, single loading dose and switch to oral PF-03709270 - 1000 mg twice a day

Sulopenem and PF-03709270drug

Sulopenem - 600 mg infused over 1 hour twice daily for a minimum of 2 days and switch to oral PF-03709270 - 1000 mg twice a day

Ceftriaxone and amoxicillin/clavulanatedrug

IV ceftriaxone (2g) infused over 30 minutes QD (once daily) for minimum of 2 days Step down oral amoxicillin/clavulanate potassium suspension (400 mg/5 ml) BID (every 12 hours)