Clinical trial NCT00797108: A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumonia, Bacterial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit
timeFrame: 7 to 14 days after end of treatment
Secondary outcomes:
measure: Percentage of Participants With Clinical Response at End of Treatment (EOT) and Follow-up Visit
timeFrame: EOT (Day 7 to 10) , Follow-up (15 to 28 days after EOT)
measure: Number of Participants With Microbiological Response at Test of Cure (TOC) Visit
timeFrame: 7 to 14 days after EOT
measure: Change From Baseline in Community Acquired Pneumonia (CAP) Symptom Questionnaire at Test of Cure (TOC) and Follow-up Visit
timeFrame: Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT)
Other outcomes:
measure: Number of Participants Who Died
timeFrame: Baseline up to 15 to 28 days after EOT
measure: Number of Participants With Abnormal Laboratory Test Findings
timeFrame: Baseline up to 15 to 28 days after EOT
measure: Number of Participants With Abnormal Physical Examination Findings
timeFrame: Last observation (up to 15-28 days after EOT, approximately 38 days)
measure: Number of Participants With Categorical Change From Baseline in Vital Signs
timeFrame: Baseline up to 15 to 28 days after EOT
measure: Population Pharmacokinetics
timeFrame: 0.5 to 1 hours, 1.5 to 3 hours, 3 to 5 hours after initiation of first intravenous dose; 0.5 to 2.5 hours, 4 to 6 hours following administration of oral dose on the day of IV to oral switch (minimum of 2 days equivalent on intravenous dose)
measure: Number of Participants With Healthcare Resource Utilization
timeFrame: Baseline up to 15 to 28 days after EOT
Locations:
city: Chula Vista
country: United States
facility: eStudySite, Inc.
state: California
city: Chula Vista
country: United States
facility: Sharp Chula Vista Medical Center
state: California
city: Oceanside
country: United States
facility: eStudySite, Inc.
state: California
city: Oceanside
country: United States
facility: Tri-City Medical Center
state: California
city: Moline
country: United States
facility: Medical Arts Associates, Ltd
state: Illinois
city: Rock Island
country: United States
facility: Trinity Medical Center
state: Illinois
city: Minneapolis
country: United States
facility: Infectious Disease Minneapolis Limited
state: Minnesota
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Provo
country: United States
facility: Utah Valley Pulmonary Clinic
state: Utah
city: Provo
country: United States
facility: Utah Valley Regional Medical Center
state: Utah
city: Brisbane
country: Australia
facility: Infection Management Services, Building 17, Level 1
state: Queensland
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - General Site
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences- McMaster Site
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Henderson Site
state: Ontario
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Division of Infectious Diseases
city: Bialystok
country: Poland
facility: Oddzial Chorob Wewnetrznych i Gastroenterologii
city: Brzesko
country: Poland
facility: Oddzial Chorob Pluc
city: Krakow
country: Poland
facility: Kliniczny Oddzial Gruzlicy i Chorob Pluc
city: Lodz
country: Poland
facility: Oddzial Kliniczny Pulmonologii i Alergologii
city: Poznan
country: Poland
facility: Oddzial Pulmonologiczny III
city: Proszowice
country: Poland
facility: Oddzial Pulmonologiczny
city: Warszawa
country: Poland
facility: II Oddzial Chorob Wewnetrznych
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: