Trials Sponsors Conditions Drugs Pricing

Conditions

Community Acquired Pneumonia Complicated Skin and Soft Tissue Infection

Keywords

BacteriaZinforo® (ceftaroline fosamil)CAPcSSTiHospitalizedInfectious DiseaseAntibioticCephalosporin

Outcome Measures

Primary Outcomes (96)

Number of Participants With Clinical Response
Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the Infectious Disease Society of America \[IDSA\] guidelines a temperature of less than or equal to (\<=) 37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of greater than or equal to (\>=) 90 millimeters of mercury (mmHg), oxygen saturation of \>=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline \[i.e., cough, dyspnea, pleuritic chest pain, sputum production\] with worsening of none). Clinical response in cSSTI participants was defined as \>=20% reduction from baseline infection area and cessation of spread measured by total infection area.
Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Time to Clinical Response
Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the IDSA guidelines a temperature of \<=37.8 degree Celsius, heart rate of \<=100 beats per minute, respiratory rate of \<=24 breaths per minute, systolic blood pressure of \>=90 mmHg, oxygen saturation of \>=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none). Clinical response in cSSTI participants was defined as \>=20% reduction from baseline infection area and cessation of spread measured by total infection area.

Study Arms (1)

Zinforo Treated

Only those Adults treated with this treatment for CAP or cSSTi

Drug: Zinforo (ceftaroline fosamil)

Interventions

Zinforo (ceftaroline fosamil)Drug

IV Solution

Also known as: Teflaro

Zinforo Treated

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The target population is adult patients aged 18 years and older hospitalized for CAP or cSSTI who received intravenous (IV) Zinforo® treatment in a usual care setting in Europe and Latin America on or before 31-May-2019.

You may qualify if:

Age 18 years or older at admission date to the hospital;

Sponsors & Collaborators

Pfizer
Industrylead

Study Sites (26)

Real Hospital Português de Beneficência

Recife, Pernambuco, 52010-075, Brazil

Hospital Esperança

Recife, 50070-480, Brazil

Clínica Las Américas

Medellín, Antioquia, 50025, Colombia

E.S.E. Hospital Universitario San Jorge de Pereira

Pereira, Risaralda Department, 660002, Colombia

Fundación Valle del Lili

Cali, Valle del Cauca Department, 760032, Colombia

Centro médico Imbanaco

Cali, Colombia

CHU Francois Mitterrand

Dijon, 21000, France

Related Publications (1)

Ferry T, Gogos C, Soriano A, Blasi F, Ansari W, Kantecki M, Schweikert B, Luna G, Bassetti M. Real-World Use and Treatment Outcomes of Ceftaroline Fosamil in Patients with Complicated Skin and Soft Tissue Infection: A Multinational Retrospective Study. Infect Drug Resist. 2024 Jul 4;17:2773-2783. doi: 10.2147/IDR.S455515. eCollection 2024.
PMID: 38979062DERIVED

Biospecimen

Retention: NONE RETAINED

Not Applicable for this study

MeSH Terms

Conditions

Community-Acquired PneumoniaSoft Tissue InfectionsCommunicable Diseases

Interventions

Ceftaroline

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Results Point of Contact

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

Study Officials

Pfizer CT.gov Call Center
Pfizer
STUDY DIRECTOR

Publication Agreements

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

Enrollment

317 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: RETROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 5, 2019

First Posted

December 13, 2019

Study Start

May 17, 2020

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (96)

Study Arms (1)

Zinforo Treated

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (26)

Related Publications (1)

Related Links

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations