A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00797108

Purpose

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.

Condition	Intervention	Phase
Pneumonia, Bacterial	Drug: sulopenem and PF-03709270 Drug: Sulopenem and PF-03709270 Drug: Ceftriaxone and amoxicillin/clavulanate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Amoxicillin Amoxicillin sodium Clavulanic acid Clavulanate potassium Amoxicillin trihydrate Ceftriaxone Ceftriaxone Sodium CP 70429 Potassium chloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

clinical response at the test of cure visit [ Time Frame: 7-14 days after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

clinical response at end of treatment and follow-up visit; [ Time Frame: end of treatment and at follow up ] [ Designated as safety issue: No ]
microbiological response at test of cure visit [ Time Frame: end of treatment ] [ Designated as safety issue: No ]
change in Community acquired pneumonia symptom questionnaire. [ Time Frame: end of treatment and follow up ] [ Designated as safety issue: No ]
Safety and tolerability will be measured by adverse event (AE) reporting including mortality, vital signs, physical examinations and safety laboratory results [ Time Frame: screening-follow up ] [ Designated as safety issue: Yes ]
Population pharmacokinetics [ Time Frame: Inpatient and day of IV to oral switch ] [ Designated as safety issue: No ]
healthcare resource utilization [ Time Frame: screening, test if cure and follow-up ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	January 2009
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Loading dose of IV sulopenem with switch to oral PF-03709270	Drug: 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: Experimental IV sulopenem with switch to oral PF-03709270	Drug: 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: Active Comparator IV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator	Drug: 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797108

Locations

United States, California
Pfizer Investigational Site
Oceanside, California, United States, 92056
Pfizer Investigational Site
Chula Vista, California, United States, 91911
United States, Illinois
Pfizer Investigational Site
Moline, Illinois, United States, 61265
Pfizer Investigational Site
Rock Island, Illinois, United States, 61201
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55422
United States, Ohio
Pfizer Investigational Site
Akron, Ohio, United States, 44304
Pfizer Investigational Site
Akron, Ohio, United States, 44309
Pfizer Investigational Site
Akron, Ohio, United States, 44310
United States, Utah
Pfizer Investigational Site
Provo, Utah, United States, 84604
Australia, Queensland
Pfizer Investigational Site
Brisbane, Queensland, Australia, 4102
Canada, Ontario
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8L 2X2
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8V 1C3
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Poland
Pfizer Investigational Site
Lodz, Poland, 90-153
Pfizer Investigational Site
Bialystok, Poland, 15-003
Pfizer Investigational Site
Brzesko, Poland, 32-800
Pfizer Investigational Site
Warszawa, Poland, 03-401
Pfizer Investigational Site
Krakow, Poland, 30-901
Pfizer Investigational Site
Poznan, Poland, 60-569
Pfizer Investigational Site
Proszowice, Poland, 32-100

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8811020
Study First Received:	November 24, 2008
Last Updated:	September 21, 2009
ClinicalTrials.gov Identifier:	NCT00797108 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Amoxicillin
Molecular Mechanisms of Pharmacological Action
Clavulanic Acids
Enzyme Inhibitors
Ceftriaxone
Amoxicillin-Potassium Clavulanate Combination
Pharmacologic Actions

Anti-Bacterial Agents
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Pneumonia, Bacterial
Lung Diseases
Clavulanic Acid
Pneumonia

ClinicalTrials.gov processed this record on February 08, 2010