You are here

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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
eStudySite, Inc.
Chula Vista, California, 91911 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Pneumonia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00797108
Pfizer
Completed
A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Complicated Intra-abdominal Infection, Hosptial Acquired Pneumonia, Ventilator Associated Pneumonia
NCT03329092
All Genders
18+
Years
Multiple Sites
Pneumococcal Pneumonia, Community Acquired Infections, Gram-positive Bacterial Infections
NCT00035269
All Genders
13+
Years
Multiple Sites
Community-Acquired Infections, Bacterial Pneumonia, Cross Infection
NCT00081575
All Genders
Bacterial Infections, HIV Infections
NCT00002344
All Genders
18+
Years
Phoenix, Arizona
A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pneumonia, Bacterial
  • 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
  • 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
  • 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)
  • Experimental: 1
    Loading dose of IV sulopenem with switch to oral PF-03709270
    Intervention: Drug: sulopenem and PF-03709270
  • Experimental: 2
    IV sulopenem with switch to oral PF-03709270
    Intervention: Drug: Sulopenem and PF-03709270
  • Active Comparator: 3
    IV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator
    Intervention: Drug: Ceftriaxone and amoxicillin/clavulanate
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
June 2009
June 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Korea, Republic of,   Poland,   United States
Hong Kong
 
NCT00797108
A8811020
2008-006307-23 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now