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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
2008-006307-23
Secondary ID [2] 0 0
A8811020
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia, Bacterial 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
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)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit - 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.
Timepoint [1] 0 0
7 to 14 days after end of treatment
Secondary outcome [1] 0 0
Percentage of Participants With Clinical Response at End of Treatment (EOT) and Follow-up Visit - 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.
Timepoint [1] 0 0
EOT (Day 7 to 10) , Follow-up (15 to 28 days after EOT)
Secondary outcome [2] 0 0
Number of Participants With Microbiological Response at Test of Cure (TOC) Visit - 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.
Timepoint [2] 0 0
7 to 14 days after EOT
Secondary outcome [3] 0 0
Change From Baseline in Community Acquired Pneumonia (CAP) Symptom Questionnaire at Test of Cure (TOC) and Follow-up Visit - 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).
Timepoint [3] 0 0
Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT)

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Infection Management Services, Building 17, Level 1 - Brisbane
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Seoul
Country [8] 0 0
Poland
State/province [8] 0 0
Bialystok
Country [9] 0 0
Poland
State/province [9] 0 0
Brzesko
Country [10] 0 0
Poland
State/province [10] 0 0
Krakow
Country [11] 0 0
Poland
State/province [11] 0 0
Lodz
Country [12] 0 0
Poland
State/province [12] 0 0
Poznan
Country [13] 0 0
Poland
State/province [13] 0 0
Proszowice
Country [14] 0 0
Poland
State/province [14] 0 0
Warszawa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00797108
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications