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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00797108
Registration number
NCT00797108
Ethics application status
Date submitted
24/11/2008
Date registered
25/11/2008
Date last updated
10/03/2016
Titles & IDs
Public title
A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization
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Scientific 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
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Secondary ID [1]
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2008-006307-23
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Secondary ID [2]
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A8811020
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pneumonia, Bacterial
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - sulopenem and PF-03709270
Treatment: Drugs - Sulopenem and PF-03709270
Treatment: Drugs - Ceftriaxone and amoxicillin/clavulanate
Experimental: 1 - Loading dose of IV sulopenem with switch to oral PF-03709270
Experimental: 2 - IV sulopenem with switch to oral PF-03709270
Active comparator: 3 - IV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator
Treatment: Drugs: 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
Treatment: Drugs: 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
Treatment: Drugs: 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)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit
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Assessment method [1]
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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.
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Timepoint [1]
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7 to 14 days after end of treatment
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Secondary outcome [1]
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Percentage of Participants With Clinical Response at End of Treatment (EOT) and Follow-up Visit
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Assessment method [1]
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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.
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Timepoint [1]
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EOT (Day 7 to 10) , Follow-up (15 to 28 days after EOT)
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Secondary outcome [2]
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Number of Participants With Microbiological Response at Test of Cure (TOC) Visit
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Assessment method [2]
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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.
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Timepoint [2]
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7 to 14 days after EOT
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Secondary outcome [3]
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Change From Baseline in Community Acquired Pneumonia (CAP) Symptom Questionnaire at Test of Cure (TOC) and Follow-up Visit
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Assessment method [3]
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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).
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Timepoint [3]
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Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT)
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2009
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Sample size
Target
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Accrual to date
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Final
35
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Infection Management Services, Building 17, Level 1 - Brisbane
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Recruitment postcode(s) [1]
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4102 - Brisbane
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Recruitment outside Australia
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United States of America
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California
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United States of America
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State/province [2]
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Illinois
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United States of America
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State/province [3]
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Minnesota
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United States of America
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Ohio
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United States of America
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Utah
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Canada
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Ontario
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Korea, Republic of
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Seoul
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Poland
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Bialystok
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Poland
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Brzesko
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Poland
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Krakow
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Poland
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Lodz
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Poland
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State/province [12]
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Poznan
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Poland
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State/province [13]
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Proszowice
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Poland
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State/province [14]
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Warszawa
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00797108
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00797108
Download to PDF