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

Pneumonia, Bacterial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797108
• Other study ID #: A8811020
• Secondary ID: 2008-006307-23
• Status: Completed
• Phase: Phase 2
• First received: November 24, 2008
• Last updated: February 11, 2016
• Start date: January 2009
• Est. completion date: June 2009

Study information

• Verified date: February 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• 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
• 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
• 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)

Locations

Country	Name	City	State
Australia	Infection Management Services, Building 17, Level 1	Brisbane	Queensland
Canada	Hamilton Health Sciences - General Site	Hamilton	Ontario
Canada	Hamilton Health Sciences - Henderson Site	Hamilton	Ontario
Canada	Hamilton Health Sciences- McMaster Site	Hamilton	Ontario
Korea, Republic of	Asan Medical Center, Division of Infectious Diseases	Seoul
Poland	Oddzial Chorob Wewnetrznych i Gastroenterologii	Bialystok
Poland	Oddzial Chorob Pluc	Brzesko
Poland	Kliniczny Oddzial Gruzlicy i Chorob Pluc	Krakow
Poland	Oddzial Kliniczny Pulmonologii i Alergologii	Lodz
Poland	Oddzial Pulmonologiczny III	Poznan
Poland	Oddzial Pulmonologiczny	Proszowice
Poland	II Oddzial Chorob Wewnetrznych	Warszawa
United States	Summa Health System	Akron	Ohio
United States	Summa Health System	Akron	Ohio
United States	Summa Health System	Akron	Ohio
United States	eStudySite, Inc.	Chula Vista	California
United States	Sharp Chula Vista Medical Center	Chula Vista	California
United States	Infectious Disease Minneapolis Limited	Minneapolis	Minnesota
United States	Medical Arts Associates, Ltd	Moline	Illinois
United States	eStudySite, Inc.	Oceanside	California
United States	Tri-City Medical Center	Oceanside	California
United States	Utah Valley Pulmonary Clinic	Provo	Utah
United States	Utah Valley Regional Medical Center	Provo	Utah
United States	Trinity Medical Center	Rock Island	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Korea, Republic of,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Who Died		Baseline up to 15 to 28 days after EOT	Yes
Other	Number of Participants With Abnormal Laboratory Test Findings	Criteria for laboratory abnormalities: hemoglobin (Hb), hematocrit, red blood cell (RBC) (less than [<] 0.8*lower limit of normal [LLN]); reticulocyte (absolute and percentage) (<0.5*LLN or greater than [>] 1.5*upper LN [ULN]); platelet (<0.5*LLN or >1.75*ULN); white blood cell (WBC) (<0.6*LLN or >1.5*ULN); lymphocyte, neutrophil (<0.8*LLN or >1.2*ULN); eosinophil, monocyte, basophil (>1.2*ULN); bilirubin (BR) (>1.5*ULN); aspartate and alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, lactate dehydrogenase (>3.0*ULN); total protein, albumin (<0.8*LLN or >1.2*ULN);blood urea nitrogen, creatinine (>1.3*ULN); sodium (<0.95*LLN or >1.05*ULN); potassium, chloride, calcium, magnesium, bicarbonate (<0.9*LLN or >1.1*ULN); glucose (<0.6*LLN or >1.5*ULN); urine (pH [<4.5 or >8], glucose, protein, blood, ketone [>=1]). Total number of participants with abnormal laboratory values were reported.	Baseline up to 15 to 28 days after EOT	Yes
Other	Number of Participants With Abnormal Physical Examination Findings	A physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, neurological, extremities, and others. Criteria for abnormal physical findings were based on investigator's discretion.	Last observation (up to 15-28 days after EOT, approximately 38 days)	Yes
Other	Number of Participants With Categorical Change From Baseline in Vital Signs	Participants who met the categorical criteria for increase in vital signs data were reported. Categorical criteria for increase from baseline vital signs data: supine and sitting systolic blood pressure (BP) of greater than or equal to (>=) 30 millimeter of mercury (mmHg); supine and sitting diastolic BP of >=20 mmHg.	Baseline up to 15 to 28 days after EOT	Yes
Other	Population Pharmacokinetics	Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study.	0.5 to 1 hours, 1.5 to 3 hours, 3 to 5 hours after initiation of first intravenous dose; 0.5 to 2.5 hours, 4 to 6 hours following administration of oral dose on the day of IV to oral switch (minimum of 2 days equivalent on intravenous dose)	No
Other	Number of Participants With Healthcare Resource Utilization	Healthcare resource utilization was to be evaluated using the assessment of the following: date and duration of index admission, duration of hospitalization, date of discharge, location of discharge, type/length of treatment inside and outside of the hospital, healthcare professional visits outside of the hospital, emergency room visits, and other hospitalizations.	Baseline up to 15 to 28 days after EOT	No
Primary	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	No
Secondary	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.	EOT (Day 7 to 10) , Follow-up (15 to 28 days after EOT)	No
Secondary	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.	7 to 14 days after EOT	No
Secondary	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).	Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT)	No

External Links

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