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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00797108
First received: November 24, 2008
Last updated: September 21, 2009
Last verified: September 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


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
Experimental: 1
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
Experimental: 2
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
Active Comparator: 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Pfizer Investigational Site
Chula Vista, California, United States, 91911
Pfizer Investigational Site
Oceanside, California, United States, 92056
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
Bialystok, Poland, 15-003
Pfizer Investigational Site
Brzesko, Poland, 32-800
Pfizer Investigational Site
Krakow, Poland, 30-901
Pfizer Investigational Site
Lodz, Poland, 90-153
Pfizer Investigational Site
Poznan, Poland, 60-569
Pfizer Investigational Site
Proszowice, Poland, 32-100
Pfizer Investigational Site
Warszawa, Poland, 03-401
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Ceftriaxone
Clavulanic Acid
Clavulanic Acids
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014