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

Sponsored by:	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

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

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

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 ]

Estimated Enrollment:	180
Study Start Date:	January 2009
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 40 Study Locations

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:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00797108 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Anti-Bacterial Agents
Amoxicillin
Respiratory Tract Infections
Respiratory Tract Diseases
Clavulanic Acid

Lung Diseases
Pneumonia, Bacterial
Clavulanic Acids
Ceftriaxone
Amoxicillin-Potassium Clavulanate Combination
Pneumonia

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 May 07, 2009