A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization
NCT ID: NCT00797108
Last Updated: 2016-03-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2009-01-31
2009-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Open-label, Randomized, and Comparative Study to Evaluate the Efficacy and Safety of Cefoperazone/Sulbactam in Comparison to Cefepime for the Treatment of Hospital-acquired Pneumonia and Healthcare-associated Pneumonia
NCT01280461
A Phase 1 Study to Assess the Safety, Tolerability and PK of IV TP-271
NCT02724085
Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects
NCT01751269
Study to Compare the Efficacy of Pristinamycin (Pyostacine ®) Versus Amoxicillin in the Treatment of Acute Community Acquired Pneumonia
NCT02332577
Safety, Tolerability, Pharmacokinetics of Intravenous RPX2014 and RPX7009 in Healthy Adult Subjects
NCT01897779
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Loading dose of IV sulopenem with switch to oral PF-03709270
sulopenem and PF-03709270
Sulopenem - 600 mg infused over 1 hour, single loading dose and switch to oral PF-03709270 - 1000 mg twice a day
2
IV sulopenem with switch to oral PF-03709270
Sulopenem and PF-03709270
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
3
IV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator
Ceftriaxone and amoxicillin/clavulanate
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
sulopenem and PF-03709270
Sulopenem - 600 mg infused over 1 hour, single loading dose and switch to oral PF-03709270 - 1000 mg twice a day
Sulopenem and PF-03709270
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/clavulanate
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
eStudySite, Inc.
Chula Vista, California, United States
Sharp Chula Vista Medical Center
Chula Vista, California, United States
eStudySite, Inc.
Oceanside, California, United States
Tri-City Medical Center
Oceanside, California, United States
Medical Arts Associates, Ltd
Moline, Illinois, United States
Trinity Medical Center
Rock Island, Illinois, United States
Infectious Disease Minneapolis Limited
Minneapolis, Minnesota, United States
Summa Health System
Akron, Ohio, United States
Summa Health System
Akron, Ohio, United States
Summa Health System
Akron, Ohio, United States
Utah Valley Pulmonary Clinic
Provo, Utah, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
Infection Management Services, Building 17, Level 1
Brisbane, Queensland, Australia
Hamilton Health Sciences - General Site
Hamilton, Ontario, Canada
Hamilton Health Sciences- McMaster Site
Hamilton, Ontario, Canada
Hamilton Health Sciences - Henderson Site
Hamilton, Ontario, Canada
Oddzial Chorob Wewnetrznych i Gastroenterologii
Bialystok, , Poland
Oddzial Chorob Pluc
Brzesko, , Poland
Kliniczny Oddzial Gruzlicy i Chorob Pluc
Krakow, , Poland
Oddzial Kliniczny Pulmonologii i Alergologii
Lodz, , Poland
Oddzial Pulmonologiczny III
Poznan, , Poland
Oddzial Pulmonologiczny
Proszowice, , Poland
II Oddzial Chorob Wewnetrznych
Warsaw, , Poland
Asan Medical Center, Division of Infectious Diseases
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008-006307-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A8811020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.