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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006307-23 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Loading dose of IV sulopenem with switch to oral PF-03709270 |
|
| 2 | Experimental | IV sulopenem with switch to oral PF-03709270 |
|
| 3 | Active Comparator | IV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Died | Baseline up to 15 to 28 days after EOT | |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| eStudySite, Inc. | Chula Vista | California | 91911 | United States | ||
| Sharp Chula Vista Medical Center |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sulopenem (Single Intravenous Dose) and PF-03709270 | Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sulopenem and PF-03709270 | Drug | 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 | 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) |
|
| 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. | 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). | Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT) |
| Baseline up to 15 to 28 days after EOT |
| 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) |
| 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 |
| 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) |
| 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 |
| Chula Vista |
| California |
| 91911 |
| United States |
| eStudySite, Inc. | Oceanside | California | 92056 | United States |
| Tri-City Medical Center | Oceanside | California | 92056 | United States |
| Medical Arts Associates, Ltd | Moline | Illinois | 61265 | United States |
| Trinity Medical Center | Rock Island | Illinois | 61201 | United States |
| Infectious Disease Minneapolis Limited | Minneapolis | Minnesota | 55422 | United States |
| Summa Health System | Akron | Ohio | 44304 | United States |
| Summa Health System | Akron | Ohio | 44309 | United States |
| Summa Health System | Akron | Ohio | 44310 | United States |
| Utah Valley Pulmonary Clinic | Provo | Utah | 84604 | United States |
| Utah Valley Regional Medical Center | Provo | Utah | 84604 | United States |
| Infection Management Services, Building 17, Level 1 | Brisbane | Queensland | 4102 | Australia |
| Hamilton Health Sciences - General Site | Hamilton | Ontario | L8L 2X2 | Canada |
| Hamilton Health Sciences- McMaster Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| Hamilton Health Sciences - Henderson Site | Hamilton | Ontario | L8V 1C3 | Canada |
| Oddzial Chorob Wewnetrznych i Gastroenterologii | Bialystok | 15-003 | Poland |
| Oddzial Chorob Pluc | Brzesko | 32-800 | Poland |
| Kliniczny Oddzial Gruzlicy i Chorob Pluc | Krakow | 30-901 | Poland |
| Oddzial Kliniczny Pulmonologii i Alergologii | Lodz | 90-153 | Poland |
| Oddzial Pulmonologiczny III | Poznan | 60-569 | Poland |
| Oddzial Pulmonologiczny | Proszowice | 32-100 | Poland |
| II Oddzial Chorob Wewnetrznych | Warsaw | 03-401 | Poland |
| Asan Medical Center, Division of Infectious Diseases | Seoul | 138-736 | South Korea |
| FG001 | Sulopenem (Multi Intravenous Dose) and PF-03709270 | Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
| FG002 | Ceftriaxone and Amoxicillin/Clavulanate | Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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|
Intent to treat (ITT) population included all randomized participants who received at least 1 dose of double blind study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sulopenem (Single Intravenous Dose) and PF-03709270 | Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
| BG001 | Sulopenem (Multi Intravenous Dose) and PF-03709270 | Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
| BG002 | Ceftriaxone and Amoxicillin/Clavulanate | Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Clinically evaluable: all ITT participants who received at least 80% of study drug, no concomitant systemic antibiotic with activity against relevant pathogens, diagnosed with pneumonia as defined by protocol inclusion criteria, assignment of pneumonia severity index (PSI) score III (low: score range 71-90)-IV(high: score range 91-130). | Posted | Number | percentage of participants | 7 to 14 days after end of treatment |
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| 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. | Clinically evaluable: all ITT participants who received at least 80% of study drug, no concomitant systemic antibiotic with activity against relevant pathogens, diagnosed with pneumonia as defined by protocol inclusion criteria, assignment of pneumonia severity index (PSI) score III (low: score range 71-90)-IV(high: score range 91-130). | Posted | Number | percentage of participants | EOT (Day 7 to 10) , Follow-up (15 to 28 days after EOT) |
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| 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. | Microbiologic clinically evaluable population included all microbiologic ITT participants (all ITT participants in whom a pathogen was isolated at baseline) who also met criteria for the clinically evaluable subset. | Posted | Number | participants | 7 to 14 days after EOT |
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| 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). | Clinically evaluable population. Here 'n' signifies participants evaluable for this measure at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT) |
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| Other Pre-specified | Number of Participants Who Died | ITT population included all randomized participants who received at least 1 dose of double blind study drug. | Posted | Number | participants | Baseline up to 15 to 28 days after EOT |
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| Other Pre-specified | 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. | ITT population included all randomized participants who received at least 1 dose of double blind study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | participants | Baseline up to 15 to 28 days after EOT |
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| Other Pre-specified | 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. | ITT population included all randomized participants who received at least 1 dose of double blind study drug. | Posted | Number | participants | Last observation (up to 15-28 days after EOT, approximately 38 days) |
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| Other Pre-specified | 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. | ITT population included all randomized participants who received at least 1 dose of double blind study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants evaluable for this measure for specified category for each arm, respectively. | Posted | Number | participants | Baseline up to 15 to 28 days after EOT |
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| Other Pre-specified | Population Pharmacokinetics | Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. | Not Posted | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | 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) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | This assessment was not performed due to the small sample size and hence data for this outcome measure is not reported. | Posted | Baseline up to 15 to 28 days after EOT |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sulopenem (Single Intravenous Dose) and PF-03709270 | Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. | 0 | 10 | 6 | 10 | ||
| EG001 | Sulopenem (Multi Intravenous Dose) and PF-03709270 | Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. | 2 | 11 | 6 | 11 | ||
| EG002 | Ceftriaxone and Amoxicillin/Clavulanate | Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. | 2 | 12 | 7 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enterocolitis | Gastrointestinal disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA v12.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v12.1 | Non-systematic Assessment |
| |
| Pyothorax | Infections and infestations | MedDRA v12.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA v12.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Catheter site pruritus | General disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v12.1 | Non-systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA v12.1 | Non-systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA v12.1 | Non-systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | MedDRA v12.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA v12.1 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA v12.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v12.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v12.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v12.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D018410 | Pneumonia, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C082897 | sulopenem |
| D002443 | Ceftriaxone |
| D000658 | Amoxicillin |
| D019818 | Clavulanic Acid |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D002969 | Clavulanic Acids |
Not provided
Not provided
| 45 to 64 years |
|
| greater than or equal to (>=) 65 years |
|
| Male |
|
| Title | Measurements |
|---|---|
|
| Indeterminate |
|
Two-sided 80% CI for the difference in the clinical cure response rates between treatement group and the comparator was formed using the exact methods.
| Clinical Cure Difference |
| 25.0 |
| 2-Sided |
| 80 |
| -13.1 |
| 57.9 |
| No |
| Superiority or Other |
| OG001 | Sulopenem (Multi Intravenous Dose) and PF-03709270 | Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
| OG002 | Ceftriaxone and Amoxicillin/Clavulanate | Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
|
|
| OG001 | Sulopenem (Multi Intravenous Dose) and PF-03709270 | Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
| OG002 | Ceftriaxone and Amoxicillin/Clavulanate | Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
|
|
| OG001 | Sulopenem (Multi Intravenous Dose) and PF-03709270 | Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
| OG002 | Ceftriaxone and Amoxicillin/Clavulanate | Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
|
|
| OG002 | Ceftriaxone and Amoxicillin/Clavulanate | Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
|
|
| OG001 | Sulopenem (Multi Intravenous Dose) and PF-03709270 | Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
| OG002 | Ceftriaxone and Amoxicillin/Clavulanate | Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
|
|
| OG002 | Ceftriaxone and Amoxicillin/Clavulanate | Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
|
|
| Sulopenem (Multi Intravenous Dose) and PF-03709270 |
Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
| OG002 | Ceftriaxone and Amoxicillin/Clavulanate | Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
|
|
| OG002 | Ceftriaxone and Amoxicillin/Clavulanate | Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator's discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator. |
|