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NCT00797108 · ClinicalTrials.gov registry record · Phase 2
A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization
A Phase 2 study of Pneumonia, Bacterial, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 20
- Study locations
NCT00797108: Completed Phase 2 study of Pneumonia, Bacterial, sponsored by Pfizer.
NCT00797108 is a Phase 2 study of Pneumonia, Bacterial that has completed, run by Pfizer. The registered enrollment target is 35 participants, below the 1,344-participant average among 7 other Pneumonia, Bacterial trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00797108, a Phase 2 study of Pneumonia, Bacterial, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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 e
Conditions Studied
Interventions
- DRUG sulopenem and PF-03709270
- DRUG Sulopenem and PF-03709270
- DRUG Ceftriaxone and amoxicillin/clavulanate
Study Locations (20)
California
- eStudySite, Inc. - Chula Vista
- Sharp Chula Vista Medical Center - Chula Vista
- eStudySite, Inc. - Oceanside
- Tri-City Medical Center - Oceanside
Other
- Oddzial Chorob Wewnetrznych i Gastroenterologii - Bialystok
- Oddzial Chorob Pluc - Brzesko
- Kliniczny Oddzial Gruzlicy i Chorob Pluc - Krakow
- Oddzial Kliniczny Pulmonologii i Alergologii - Lodz
Ohio
- Summa Health System - Akron
- Summa Health System - Akron
- Summa Health System - Akron
Ontario
- Hamilton Health Sciences - General Site - Hamilton
- Hamilton Health Sciences- McMaster Site - Hamilton
- Hamilton Health Sciences - Henderson Site - Hamilton
Illinois
- Medical Arts Associates, Ltd - Moline
- Trinity Medical Center - Rock Island
Utah
- Utah Valley Pulmonary Clinic - Provo
- Utah Valley Regional Medical Center - Provo
Minnesota
- Infectious Disease Minneapolis Limited - Minneapolis
Queensland
- Infection Management Services, Building 17, Level 1 - Brisbane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2009-01 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
What the finished NCT00797108 record still lists
NCT00797108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,344-participant average among 7 other Pneumonia, Bacterial trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Pneumonia, Bacterial appearing as the primary indexed condition, and to 3 interventions - of which sulopenem and PF-03709270 is the first listed.
NCT00797108 names 20 study sites across 8 states, led by California, Other, Ohio.
Frequently Asked Questions
What is clinical trial NCT00797108 about?
NCT00797108 is a clinical study titled "A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization". 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.
What is the current status of trial NCT00797108?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2009-01. Estimated completion is 2009-06.
What conditions does trial NCT00797108 study?
This clinical trial studies the following conditions: Pneumonia, Bacterial.
What interventions are being tested in trial NCT00797108?
The interventions under investigation include: sulopenem and PF-03709270 (DRUG), Sulopenem and PF-03709270 (DRUG), Ceftriaxone and amoxicillin/clavulanate (DRUG).
Who is sponsoring clinical trial NCT00797108?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00797108 being conducted?
This trial has 20 study locations across California, Illinois, Minnesota, Ohio, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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