Real-World Observational Study Of Zavicefta to Characterize Use Patterns

NCT ID: NCT03923426

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 572 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2022-03-28

Brief Summary

This is a non-interventional medical chart review study aiming to examine the treatment patterns, effectiveness, and safety of ceftazidime-avibactam in approximately 12 countries (including but not limited to Austria, France, Germany, Greece, Italy, Spain, United Kingdom, Russia, Argentina, Colombia, Brazil, and Mexico), with possible expansion to other countries as ceftazidime-avibactam is launched. Eligible patients are adults who have been treated with ceftazidime-avibactam in routine practice at participating sites since 01 January, 2018 onwards or since the date of launch in the country if it is posterior to 01 January, 2018. As this is an observational study, patients will be treated based on the standard of care at the discretion of their physician. No drugs will be supplied for this study and patients will receive treatment through standard local practice.

Detailed Description

This observational study will include approximately 700 hospitalized patients with a gram-negative infection, who have received at least one dose of ceftazidime-avibactam.

Patients will be recruited in approximately 62 sites across 12 countries in Europe (including Russia) and Latin America. Patients will be followed from ceftazidime-avibactam initiation until 60 days post hospital discharge, mortality, withdrawal from the study, or loss-to-follow-up, whichever occurs first.

Data will be abstracted from medical records using an electronic case report form (eCRF). Baseline data include patient socio-demographics, medical history, and clinical and microbiological characteristics of the infection treated.

Follow-up data will include details of treatment over time and clinical, microbiological, and healthcare resource utilization outcomes.

Evaluation of clinical success will be performed in patients with at least ≥72 hours of exposure to ceftazidime-avibactam.

Safety will be evaluated in all patients exposed to at least one dose of the product.

Conditions

Infection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

Zavicefta Treatment

Non-interventional - Retrospective Chart Review

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Hospitalized patient ≥18 years old or considered an adult in accordance with the age of majority in the participant's country of residence at the time of treatment with ceftazidime-avibactam.

2. Patient received ≥1 dose of ceftazidime-avibactam in routine practice at participating site since 01 January, 2018 onwards or since the date of launch in the country if it is after 01 January, 2018.

3. Patient underwent microbiologic sampling ≤5 days before the initiation of ceftazidime-avibactam (irrespective of results and actual bacteriological identification).

4. Patient has all required essential data elements which include:

1. Start and stop dates of ceftazidime-avibactam,

2. Start and stop dates of prior antibiotic therapy used for the index infection,

3. Type of combined antibiotic therapy (if applicable) and start and stop dates of any antibiotic combined with ceftazidime-avibactam.

5. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study where required by local regulations.

Exclusion Criteria

1. The patient is enrolled in any clinical trial of an investigational product. Patients who are enrolled in non-interventional studies (NISs) (e.g. registries) are eligible for inclusion.

2. The patient has received ceftazidime-avibactam in a compassionate care program setting.

3. The patient was exposed to ceftazidime-avibactam before use for the index infection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Hospital Aleman

Buenos Aires, , Argentina

Hospital Britanico de Buenos Aires

CABA, , Argentina

CEMIC

Ciudad Autonoma Buenos Aires, , Argentina

Hospital Italiano

Ciudad Autonoma Buenos Aires, , Argentina

Hospital Privado Centro Medico de Cordoba S.A.

Córdoba, , Argentina

Sanatorio Britanico S.A.

Rosario, , Argentina

AKH - Medizinische Universität Wien

Vienna, , Austria

Hospital Felício Rocho

Belo Horizonte, , Brazil

Hospital Vera Cruz

Belo Horizonte, , Brazil

CEPETI - Centro de Estudos e Pesquisa em Emergências Médicas e Terapia Intensiva

Curitiba, , Brazil

Hospital Moinho de Ventos

Porto Alegre, , Brazil

Hospital de Caridade de Santa Maria -HCAA

Santa Maria, , Brazil

Centro médico Imbanaco

Cali, , Colombia

Caja de Compensacion Familiar de Caldas / Confa

Manizales, , Colombia

Promotora Medica Las Americas SA

Medellín, , Colombia

IPS Universitaria

Medellín, , Colombia

CHU Angers - Hôpital Hôtel Dieu

Angers, , France

CHU Nantes - Hôtel Dieu pt

Nantes, , France

Groupe Hospitalier Pitie-Salpetriere

Paris, , France

Hôpital Bichat - Claude Bernard

Paris, , France

Centre Hospitalier de Tourcoing

Tourcoing, , France

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt, , Germany

University Hospital Jena

Jena, , Germany

University of Patras Medical School

Pátrai, Achaia, Greece

General Hospital of Athens Laiko

Athens, Attica, Greece

Policlinico Universitario Agostino Gemelli

Rome, ROMA, Italy

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Bologna, , Italy

Azienda Ospedaliero Universitaria San Martino

Genoa, , Italy

Azienda Ospedaliera Universitaria Pisana

Pisa, , Italy

Ospedale Amedeo di Savoia

Torino, , Italy

Regional Clinical Hospital #1

Krasnodar, , Russia

SBIH of Moscow City Clinical Hospital # 7

Moscow, , Russia

FSBI "State Scientific Centre of Coloproctology" of the MoH of RF

Moscow, , Russia

FSBI "Hematological Research Center" MoH of RF

Moscow, , Russia

North-West Federal Medical Research Center n.a. V.A. Almazov

Saint Petersburg, , Russia

SBIH Republican Clinical Hospital n.a. G. G. Kuvatov

Ufa, , Russia

Complexo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Universitari de Bellvitge

Barcelona, , Spain

Hospital Universitario Reina Sofía

Córdoba, , Spain

Hopsital Ramón y Cajal

Madrid, , Spain

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Sheffield Teaching Hospitals

Sheffield, South Yorkshire, United Kingdom

Kings College Hospital NHS Foundation Trust

London, , United Kingdom

Chelsea and Westminster Hospital

London, , United Kingdom

Countries

Argentina; Austria; Brazil; Colombia; France; Germany; Greece; Italy; Russia; Spain; United Kingdom

References

Soriano A, Montravers P, Bassetti M, Klyasova G, Daikos G, Irani P, Stone G, Chambers R, Peeters P, Shah M, Hulin C, Albuquerque N, Basin E, Gaborit B, Kourbeti I, Menichetti F, Perez-Rodriguez MT, Pletz MW, Sanchez M, Trompa I, Verma A, de Figueiredo MLN, Charbonneau C. The Use and Effectiveness of Ceftazidime-Avibactam in Real-World Clinical Practice: EZTEAM Study. Infect Dis Ther. 2023 Mar;12(3):891-917. doi: 10.1007/s40121-023-00762-9. Epub 2023 Feb 10.

Reference Type: DERIVED

PMID: 36763243 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C3591031

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

Other Identifiers

EZTEAM STUDY

Identifier Type: OTHER

Identifier Source: secondary_id

C3591031

Identifier Type: -

Identifier Source: org_study_id