A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization
- Conditions
- Pneumonia, Bacterial
- Interventions
- Registration Number
- NCT00797108
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Sulopenem and PF-03709270 Loading dose of IV sulopenem with switch to oral PF-03709270 2 Sulopenem and PF-03709270 IV sulopenem with switch to oral PF-03709270 3 Ceftriaxone and amoxicillin/clavulanate IV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator
- Primary Outcome Measures
Name Time Method Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit 7 to 14 days after end of treatment Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At TOC (7 to 14 days after end of treatment \[EOT\]) CR was evaluated as "cure"=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; "failure"=persistence or progression of baseline signs and symptoms of pneumonia (for example: body temperature, white blood cell \[WBC\] count, respiratory rate, auscultatory findings, cough, sputum production), development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; "indeterminate"=extenuating circumstances precluded classification to 1 of the above.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Community Acquired Pneumonia (CAP) Symptom Questionnaire at Test of Cure (TOC) and Follow-up Visit Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT) The CAP Symptom Questionnaire was a participant reported questionnaire administered by interview. It consisted of 12 items (coughing, chest pains, shortness of breath, sweating, chills, headache, nausea, muscle pain, lack of appetite, trouble concentrating, trouble sleeping, and fatigue). Depending on if the participant had or not had symptoms/problems, they were asked how much they had been bothered by the symptoms/problems over the previous 24 hours. CAP items were rated on the 6-point response scale (0 = participant did not have symptom/problem: 1 = not at all, 2 = a little, 3 = moderately, 4 = quite a bit, 5 = extremely; if the participant had the symptom/problem and were bothered). All 12 items score were summed and averaged to produce a CAP symptom score (range, 0 to 6). High values indicated poorer outcomes (higher symptom bothersomeness).
Number of Participants With Microbiological Response at Test of Cure (TOC) Visit 7 to 14 days after EOT Microbiological response assessed at participant level. Eradication=the absence of the original pathogens from the post-treatment TOC culture of specimen from the original site of infection. Presumed eradication=the complete resolution of signs and symptoms associated with cessation of culturable specimen (for example, sputum). Persistence=the presence of the original pathogen in the post-treatment TOC culture specimen from the original site of infection. Presumed persistence=in a participant who was judged to be a clinical failure and a culture of specimen was not possible or was not done, it was presumed that there was persistence of the pathogen. Not applicable microbiologic response included participants that did not have post-treatment microbiologic cultures due to early discontinuation. Data reported for eradication is combination of eradication and presumed eradication data and data reported for persistence is combination of persistence and presumed persistence data.
Percentage of Participants With Clinical Response at End of Treatment (EOT) and Follow-up Visit EOT (Day 7 to 10) , Follow-up (15 to 28 days after EOT) CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOT (Day 7 to 10) and follow-up (15 to 28 days after EOT), CR was evaluated as "cure"=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; "failure"=persistence or progression of baseline signs and symptoms of pneumonia, development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; with additional CR evaluated as "improvement"= of few not all signs and symptoms of pneumonia when compared to baseline and no additional antibacterial treatment required at EOT and "indeterminate"=extenuating circumstances precluded classification to 1 of the above at follow-up.
Trial Locations
- Locations (21)
Hamilton Health Sciences- McMaster Site
🇨🇦Hamilton, Ontario, Canada
Oddzial Chorob Wewnetrznych i Gastroenterologii
🇵🇱Bialystok, Poland
Asan Medical Center, Division of Infectious Diseases
🇰🇷Seoul, Korea, Republic of
Utah Valley Pulmonary Clinic
🇺🇸Provo, Utah, United States
Infection Management Services, Building 17, Level 1
🇦🇺Brisbane, Queensland, Australia
Utah Valley Regional Medical Center
🇺🇸Provo, Utah, United States
Oddzial Pulmonologiczny
🇵🇱Proszowice, Poland
Oddzial Pulmonologiczny III
🇵🇱Poznan, Poland
Oddzial Chorob Pluc
🇵🇱Brzesko, Poland
Kliniczny Oddzial Gruzlicy i Chorob Pluc
🇵🇱Krakow, Poland
Oddzial Kliniczny Pulmonologii i Alergologii
🇵🇱Lodz, Poland
II Oddzial Chorob Wewnetrznych
🇵🇱Warszawa, Poland
Tri-City Medical Center
🇺🇸Oceanside, California, United States
eStudySite, Inc.
🇺🇸Oceanside, California, United States
Hamilton Health Sciences - General Site
🇨🇦Hamilton, Ontario, Canada
Infectious Disease Minneapolis Limited
🇺🇸Minneapolis, Minnesota, United States
Summa Health System
🇺🇸Akron, Ohio, United States
Medical Arts Associates, Ltd
🇺🇸Moline, Illinois, United States
Hamilton Health Sciences - Henderson Site
🇨🇦Hamilton, Ontario, Canada
Sharp Chula Vista Medical Center
🇺🇸Chula Vista, California, United States
Trinity Medical Center
🇺🇸Rock Island, Illinois, United States