N/A N=317

Retrospective Chart Review Study to Assess Characteristics, Treatment Outcomes and Resource Use of Adults Hospitalized for CAP and CSSTi Treated With Zinforo in Multiple Countries

Community Acquired Pneumonia · Complicated Skin and Soft Tissue Infection

Bottom Line

View on ClinicalTrials.gov: NCT04198571 ↗

Enrolled (actual)

317

Serious AEs

0.6%

Results posted

Mar 2024

Primary outcome: Primary: Number of Participants With Clinical Response — 151; 118 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Zinforo (ceftaroline fosamil) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Clinical Response	151; 118	—
PRIMARY Time to Clinical Response	4; 4	—
PRIMARY Number of Participants Who Achieved Clinical Cure	115; 72	—
PRIMARY Time to Clinical Cure	7; 5	—
PRIMARY Number of Participants With Clinical Failure	34; 14	—
PRIMARY CAP: Number of Participants According to Reasons for Clinical Failure	21; 7; 2; 2; 2	—
PRIMARY cSSTI: Number of Participants According to Reasons for Clinical Failure	1; 10; 3	—
PRIMARY CAP Only: Time to Clinical Stability	3	—
PRIMARY CAP Only: Time to Clinical Improvement	3	—
PRIMARY CAP: Number of Participants With Early Response Within 4 Days	79	—
PRIMARY cSSTI: Number of Participants With Early Response Within 3 Days	20	—
PRIMARY cSSTI Only: Time to Greater Than or Equal to (>=) 20% Reduction From Baseline in Infection Area	3	—
PRIMARY cSSTI Only: Time to Cessation of Spread Measured by Total Infection Area	2	—
PRIMARY cSSTI Only: Time to Cessation of Spread Measured by Infection Length and Width	2	—
PRIMARY Number of Participants According to Discharge Status	18; 6; 28; 23; 138; 101	—
PRIMARY Number of Participants With Re-hospitalization Within 30 Days of Discharge	20; 13	—
PRIMARY Number of Participants According to Vital Status Within 30 Days of Discharge	126; 98; 31; 15; 28; 19	—
PRIMARY Number of Participants According to Minimum Inhibitory Concentration (MIC) Assessment	23; 28; 161; 94; 1; 10	—
PRIMARY Day of MIC Assessment Since Index Hospitalization	1; 4	—
PRIMARY Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens	5; 7; 12; 20; 3; 6	—
PRIMARY Number of Participants With Serious Adverse Events	0; 2	—
PRIMARY Number of Participants With Medical Conditions Presented at Index Hospitalization	147; 99	—
PRIMARY Number of Participants With Hospitalization for Any Reason in the 3 Months Before the Index Hospitalization	34; 44	—
PRIMARY Number of Participants With Invasive Major Surgical Treatment in the 3 Months Before the Index Hospitalization	5; 24	—
PRIMARY Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization	47; 56; 21; 19; 38; 45	—
PRIMARY Number of Participants With Radiographic Findings in Tests for CAP	130; 68; 48; 30; 3	—
PRIMARY CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization	129; 80; 138; 148; 127; 122	—
PRIMARY Number of Participants With Severe CAP	128	—
PRIMARY Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity	18; 41; 15; 71; 40	—
PRIMARY Time of CAP Diagnosis at Index Hospitalization	1	—
PRIMARY Number of Participants With Recurrent CAP Infections at Index Hospitalization	10	—
PRIMARY Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization	44; 2; 3; 1; 2; 4	—
PRIMARY Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization	33; 39; 10; 4; 5; 30	—
PRIMARY CAP: Number of Participants With Polymerase Chain Reaction (PCR) Determination of H1N1 Influenza Virus at Index Hospitalization	71	—
PRIMARY CAP: Number of Participants According to Influenza Vaccination Status During 12 Months Prior to Index Hospitalization	32; 64; 89	—
PRIMARY CAP: Number of Participants According to Pneumococcal Vaccination Status at Index Hospitalization	18; 76; 91	—
PRIMARY CAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index Hospitalization	182; 73; 8; 2	—
PRIMARY cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization	45; 82; 9; 26; 5; 5	—
PRIMARY cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization	13; 3; 14; 74; 19; 14	—
PRIMARY cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization	12; 31; 34; 8; 47	—
PRIMARY cSSTI: Number of Participants According to Level of Infections at Index Hospitalization	51; 51; 20; 10	—
PRIMARY cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization	61; 92; 88; 61; 23; 25	—
PRIMARY Time of cSSTI Diagnosis at Index Hospitalization	5	—
PRIMARY cSSTI: Number of Participants With Recurrent Infection at Index Hospitalization	33	—
PRIMARY cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization	65; 5; 106; 30; 90; 100	—
PRIMARY Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization	77; 108; 4; 13; 1	—
PRIMARY cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization	85; 40; 14; 7; 22; 31	—
PRIMARY cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization	24; 23; 8; 1; 4; 1	—
PRIMARY Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization	5; 6; 17; 20; 12; 4	—
PRIMARY Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization	134; 87; 85; 58; 40; 24	—
PRIMARY Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization	44; 31; 111; 73; 7; 0	—
PRIMARY Duration of Pre-Zinforo Treatment During Index Hospitalization	6; 8	—
PRIMARY Time From Symptom Onset to First Dose of Pre-Zinforo Treatment	3; 2	—
PRIMARY Number of Participants According to Types of Pre-Zinforo Treatment During Index Hospitalization	129; 74; 13; 19; 6; 10	—
PRIMARY Number of Doses Administered for Pre-Zinforo Treatment During Index Hopsitalization	2.02; 2.18	—
PRIMARY Number of Participants With Pre-Zinforo Treatment Modification During Index Hospitalization	91; 60	—
PRIMARY Number of Participants According to Reasons for Pre-Zinforo Treatment Modification	5; 3; 58; 42; 1; 1	—
PRIMARY Number of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index Hospitalization	12; 17; 89; 14; 33; 62	—
PRIMARY Time to Treatment Modification From Initial Dose of Pre-Zinforo Treatment	2; 3	—
PRIMARY Number of Participants With Insufficient Response to Pre-Zinforo Treatment During Index Hospitalization	58; 42	—
PRIMARY Duration of Zinforo Treatment During Index Hospitalization	7; 8	—
PRIMARY Time From Admission to First Dose of Zinforo During Index Hospitalization	1; 1	—
PRIMARY Time From Symptom Onset to First Dose of Zinforo During Index Hospitalization	6; 7	—
PRIMARY Number of Participants According to Types of Treatment for Zinforo	138; 84; 41; 43; 6; 5	—
PRIMARY Daily Dose of Zinforo	1183.24; 1239.39	—
PRIMARY Number of Infusions Administered Daily for Zinforo	2.28; 2.27	—
PRIMARY Number of Participants According to Locations of Zinforo Administration	66; 11; 115; 114; 1; 14	—
PRIMARY Number of Participants Administered Zinforo as Monotherapy or Combination Therapy	56; 78; 129; 54	—
PRIMARY Number of Participants Receiving Concomitant Therapies Along With Zinforo	131; 92	—
PRIMARY Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment	9; 3; 13; 4; 8; 5	—
PRIMARY Number of Participants According to Lines of Therapy for Post-Zinforo Treatment	1; 2; 45; 46; 40; 20	—
PRIMARY Number of Participants According to Route of Administration for Post-Zinforo Treatment	92; 81; 112; 38	—
PRIMARY Duration From Zinforo Discontinuation to Initiation of New Treatment	1; 1	—
PRIMARY Number of Doses Administered for Post Zinforo Treatment	11.05; 16.38	—
PRIMARY Number of Participants According to Reasons for Switching to Post-Zinforo Treatment	39; 9; 1; 9; 26; 14	—
PRIMARY Number of Participants Based on Treatment Response to Post-Zinforo Treatment	155; 95; 26; 4; 23; 20	—
PRIMARY Number of Participant According to Type of Location for Post-Zinforo Treatment Administration	70; 1; 86; 42; 64; 70	—
PRIMARY Number of Participants Who Achieved Clinical Response to Post-Zinforo Treatment	139; 89	—
PRIMARY Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment	2; 0; 14; 1; 1; 0	—
PRIMARY Duration of Index Hospitalization	12; 11	—
PRIMARY Duration in Intensive Care Unit	0; 0	—
PRIMARY Number of Participants Who Received Renal Replacement Therapy Post Initiating Treatment With Zinforo	5; 2	—
PRIMARY Number of Participants According to Treatments Received During Index Hospitalization	5; 37; 1; 0; 44; 12	—
PRIMARY Number of Participants Who Received Home-Based Care Through a Healthcare Agency	16; 35	—
PRIMARY Number of Participants With Re-hospitalizations	20; 13	—
PRIMARY Duration of Re-hospitalizations	10.5; 9	—
PRIMARY Number of Participants According to Reasons for Re-hozpitalization	7; 3; 13; 10	—
PRIMARY Number of Participants With Development of Sepsis During Index Hospitalization	38; 29	—
PRIMARY Number of Participants With Quick Sepsis-Related Organ Failure Assessment (qSOFA) Conducted	74; 40	—
PRIMARY Number of Participants Requiring Isolation	20; 10	—
PRIMARY Number of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral Nutrition	56; 11; 37; 6; 17; 5	—
PRIMARY Number of Participants Who Suffered Acute Renal Failure Necessitating Renal Replacement	11; 4	—
PRIMARY Total Number of Doses of Zinforo Administered	18.96; 23.29	—
PRIMARY Total Number of Doses of Other Antibiotics Administered in Combination With Zinforo	8.48; 8.48	—
PRIMARY Total Dose of Other Antibiotics Administered Post Zinforo Treatment	11.05; 11.05	—
PRIMARY Cost of Hospitalization	9204.62; 5196.2; 25408.01; 20257.18	—

Summary

MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalized for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated with Zinforo® (ceftaroline fosamil) in a Usual Care Setting

Eligibility Criteria

Inclusion criteria

Age 18 years or older at admission date to the hospital;
Received four (4) or more consecutive IV doses of Zinforo® in usual care on or before 31-May-2019; and
Admitting diagnosis to the hospital was either CAP or cSSTI.

Exclusion criteria

Patients who were participating in an interventional clinical trial during the same hospital admission in which Zinforo® was administered;
Patients whose hospital medical records are missing documentation of the diagnostic criteria for either cSSTI or CAP;
Patients whose hospital medical records are missing details of dosing with Zinforo®;
Patients whose hospital medical records are missing information on the success/failure of Zinforo® treatment and the reason why treatment was discontinued; and
Patients whose hospital medical records are missing discharge date and status information.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04198571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.