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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious 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
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
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
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
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
Sex
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
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2009
Sample size
Target
Accrual to date
Final
35
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00797108