Pneumonia, BacterialPhase 2NCT00797108
A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization
A Phase 2 study testing sulopenem and PF-03709270 and Ceftriaxone and amoxicillin/clavulanate in people with Pneumonia, Bacterial, run by Pfizer at 24 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Bacterial
- What is being tested?
- sulopenem and PF-03709270 and Ceftriaxone and amoxicillin/clavulanate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 24 sitesin 5 countries
- Study dates
- Jan 2009to Jun 2009
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
United States12 sites
Summa Health System
Akron, Ohio, 44304
Summa Health System
Akron, Ohio, 44309
Summa Health System
Akron, Ohio, 44310
eStudySite, Inc.
Chula Vista, California, 91911
Sharp Chula Vista Medical Center
Chula Vista, California, 91911
Infectious Disease Minneapolis Limited
Minneapolis, Minnesota, 55422
Medical Arts Associates, Ltd
Moline, Illinois, 61265
eStudySite, Inc.
Oceanside, California, 92056
Tri-City Medical Center
Oceanside, California, 92056
Utah Valley Pulmonary Clinic
Provo, Utah, 84604
Utah Valley Regional Medical Center
Provo, Utah, 84604
Trinity Medical Center
Rock Island, Illinois, 61201
Poland7 sites
Oddzial Chorob Wewnetrznych i Gastroenterologii
Bialystok, 15-003
Oddzial Chorob Pluc
Brzesko, 32-800
Kliniczny Oddzial Gruzlicy i Chorob Pluc
Krakow, 30-901
Oddzial Kliniczny Pulmonologii i Alergologii
Lodz, 90-153
Oddzial Pulmonologiczny III
Poznan, 60-569
Oddzial Pulmonologiczny
Proszowice, 32-100
II Oddzial Chorob Wewnetrznych
Warsaw, 03-401
Canada3 sites
Hamilton Health Sciences - General Site
Hamilton, Ontario, L8L 2X2
Hamilton Health Sciences- McMaster Site
Hamilton, Ontario, L8N 3Z5
Hamilton Health Sciences - Henderson Site
Hamilton, Ontario, L8V 1C3
Australia1 site
Infection Management Services, Building 17, Level 1
Brisbane, Queensland, 4102
South Korea1 site
Asan Medical Center, Division of Infectious Diseases
Seoul, 138-736
About this study
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
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.
- Conditions
- Pneumonia, Bacterial
- Being tested
- sulopenem and PF-03709270, Ceftriaxone and amoxicillin/clavulanate
- Medical subject headings
- Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sulopenem and PF-03709270Drug
Sulopenem - 600 mg infused over 1 hour, single loading dose and switch to oral PF-03709270 - 1000 mg twice a day
Sulopenem and PF-03709270Drug
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
Ceftriaxone and amoxicillin/clavulanateDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Loading dose of IV sulopenem with switch to oral PF-03709270 Receives: Drug: sulopenem and PF-03709270 |
| 2 | Experimental | IV sulopenem with switch to oral PF-03709270 Receives: Drug: Sulopenem and PF-03709270 |
| 3 | Active comparator | IV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator Receives: Drug: Ceftriaxone and amoxicillin/clavulanate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 to 14 days after end of treatment
Secondary outcomes (3)
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.
Measured: EOT (Day 7 to 10) , Follow-up (15 to 28 days after EOT)
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.
Measured: 7 to 14 days after EOT
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).
Measured: Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pneumonia, BacterialStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797108
- Sponsor's protocol ID
- A8811020
- Other IDs
- 2008-006307-23, 2008
- Status last verified
- Feb 2016
- First submitted
- 24 Nov 2008
- Last updated
- 10 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No