A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization

NCT00797108 | Completed Phase 2 Results

• 2 other identifiers: A88110202008-006307-23
• Study Type: interventional
• Target: 35
• Locations: 5 countries
• Sites: 24

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.

Conditions

Pneumonia, Bacterial

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT)

Other Outcomes (6)

• Number of Participants Who Died

  Baseline up to 15 to 28 days after EOT

• Number of Participants With Abnormal Laboratory Test Findings

  Baseline up to 15 to 28 days after EOT

• Number of Participants With Abnormal Physical Examination Findings

  Last observation (up to 15-28 days after EOT, approximately 38 days)

Study Arms (3)

1

EXPERIMENTAL

Loading dose of IV sulopenem with switch to oral PF-03709270

Drug: sulopenem and PF-03709270

2

EXPERIMENTAL

IV sulopenem with switch to oral PF-03709270

Drug: Sulopenem and PF-03709270

3

ACTIVE COMPARATOR

IV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator

Drug: Ceftriaxone and amoxicillin/clavulanate

Interventions

Sulopenem and PF-03709270 DRUG

Sulopenem - 600 mg infused over 1 hour, single loading dose and switch to oral PF-03709270 - 1000 mg twice a day

1

Ceftriaxone and amoxicillin/clavulanate DRUG

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)

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (24)

eStudySite, Inc.

Chula Vista, California, 91911, United States

Location

Sharp Chula Vista Medical Center

Chula Vista, California, 91911, United States

Location

eStudySite, Inc.

Oceanside, California, 92056, United States

Location

Tri-City Medical Center

Oceanside, California, 92056, United States

Location

Medical Arts Associates, Ltd

Moline, Illinois, 61265, United States

Location

Trinity Medical Center

Rock Island, Illinois, 61201, United States

Location

Infectious Disease Minneapolis Limited

Minneapolis, Minnesota, 55422, United States

Location

Summa Health System

Akron, Ohio, 44304, United States

Location

Summa Health System

Akron, Ohio, 44309, United States

Location

Summa Health System

Akron, Ohio, 44310, United States

Location

Utah Valley Pulmonary Clinic

Provo, Utah, 84604, United States

Location

Utah Valley Regional Medical Center

Provo, Utah, 84604, United States

Location

Infection Management Services, Building 17, Level 1

Brisbane, Queensland, 4102, Australia

Location

Hamilton Health Sciences - General Site

Hamilton, Ontario, L8L 2X2, Canada

Location

Hamilton Health Sciences- McMaster Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hamilton Health Sciences - Henderson Site

Hamilton, Ontario, L8V 1C3, Canada

Location

Oddzial Chorob Wewnetrznych i Gastroenterologii

Bialystok, 15-003, Poland

Location

Oddzial Chorob Pluc

Brzesko, 32-800, Poland

Location

Kliniczny Oddzial Gruzlicy i Chorob Pluc

Krakow, 30-901, Poland

Location

Oddzial Kliniczny Pulmonologii i Alergologii

Lodz, 90-153, Poland

Location

Oddzial Pulmonologiczny III

Poznan, 60-569, Poland

Location

Oddzial Pulmonologiczny

Proszowice, 32-100, Poland

Location

II Oddzial Chorob Wewnetrznych

Warsaw, 03-401, Poland

Location

Asan Medical Center, Division of Infectious Diseases

Seoul, 138-736, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumonia, Bacterial

Interventions

sulopenem; Ceftriaxone; Amoxicillin; Clavulanic Acid

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ampicillin; Penicillin G; Penicillins; Clavulanic Acids

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 10, 2016
• Results First Posted: March 10, 2016

Record last verified: 2016-02

Locations

CA (3); AU (1); KR (1); US (12); PL (7)