Clinical trial NCT03923426: Real-World Observational Study Of Zavicefta to Characterize Use Patterns
Official title: REAL-WORLD OBSERVATIONAL STUDY OF ZAVICEFTA (REGISTERED) (CEFTAZIDIME-AVIBACTAM) TO CHARACTERIZE USE PATTERNS, EFFECTIVENESS AND SAFETY - EZTEAM STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: ceftazidime-avibactam
Zavicefta
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-04-22
Enrollment: 572
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with ≥72 hours of exposure to ceftazidime-avibactam at 42 European sites. Patients will be identified over a 12-month period and information about treatment will be abstracted from medical records after treatment completion. Patients will be followed from ceftazidime-avibactam initiation until 60 days post hospital discharge, mortality, withdrawal, or loss-to-follow-up, whichever occurs first.

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.

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:

Patients must not meet any of the following exclusion criteria to be eligible:

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.

Primary outcomes:
measure: Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS 72+ Population
timeFrame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS72- Population
timeFrame: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
measure: Total and Daily Dose of Ceftazidime-Avibactam: FAS72+ Population
timeFrame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
measure: Total and Daily Dose of Ceftazidime-Avibactam: FAS72- Population
timeFrame: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Classified According to Frequency of Dosing: FAS72+ Population
timeFrame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Classified According to Frequency of Dosing: FAS72- Population
timeFrame: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
measure: Total Duration of Administration of Ceftazidime-Avibactam: FAS72+ Population
timeFrame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
measure: Total Duration of Administration of Ceftazidime-Avibactam: FAS72- Population
timeFrame: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population
timeFrame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population
timeFrame: From start of index treatment to end of index treatment (maximum 3 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population
timeFrame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population
timeFrame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population
timeFrame: From start of index treatment to end of index treatment (maximum 179 days of treatment exposure) (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Whose Samples Were Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: Microbiology Outcomes Dataset (MOD) Population
timeFrame: From end of index therapy up to 60 days after hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population
timeFrame: From end of index therapy up to 60 days after hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population
timeFrame: After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
measure: Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population
timeFrame: After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
measure: Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population
timeFrame: After treatment initiation up to 60 days post hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Classified According to Type of Clinical Evaluation Outcome at Initial Hospitalization: Clinical Outcomes Dataset (COD) Population
timeFrame: At initial hospitalization (from the data evaluated in approximately 40 months of this study)
measure: Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Discharge: Clinical Outcomes Dataset (COD) Population
timeFrame: 60 days after hospital discharge (from the data evaluated in approximately 40 months of this study)
measure: Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Treatment: Clinical Outcomes Dataset (COD) Population
timeFrame: 60 days post treatment (from the data evaluated in approximately 40 months of this study)
measure: Number of Participants With Microbiological Treatment Outcome as Success: MOD Population
timeFrame: Up to 14 days post first dose of ceftazidime-avibactam (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Classified According to Antibiotics Used for Current Infection Before Ceftazidime-Avibactam: FAS72+ Population
timeFrame: Up to 90 days prior to index date (from the data evaluated in approximately 40 months of this study)
measure: Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population
timeFrame: Up to 90 days prior to index date (from the data evaluated in approximately 40 months of this study)
measure: Percentage of Participants Who Died During Index Hospitalization
timeFrame: During index hospitalization, maximum of 418 days (from the data evaluated in approximately 40 months of this study)
measure: Percentage of Participants Who Died Within the 30 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population
timeFrame: From index treatment up to 30 days post hospital discharge, maximum of 434 days (from the data evaluated in approximately 40 months of this study)
measure: Percentage of Participants Who Died Within 60 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population
timeFrame: From index treatment up to 60 days post hospital discharge, maximum of 434 days (from the data evaluated in approximately 40 months of this study)
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 464 days (from the data evaluated in approximately 40 months of the study)
measure: Duration of Hospital Stay: FAS72+ Population
timeFrame: From index date up to hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first maximum of 418 days (from the data evaluated in approximately 40 months of the study)
measure: Total Duration of ICU Stay: FAS72+ Population
timeFrame: During index hospitalization, maximum up to 418 days (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Readmitted to the Hospital During the 30 Days After Initial Discharge: FAS72+ Population
timeFrame: Up to 30 days after initial discharge (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Readmitted to the Hospital During the 60 Days After Initial Discharge: FAS72+ Population
timeFrame: Up to 60 days after initial discharge (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Classified According to Reason for Readmission to the Hospital: FAS72+ Population
timeFrame: At readmission to the hospital, up to maximum of 60 days post initial hospital discharge (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population
timeFrame: During index hospitalization maximum of 418 days (from the data evaluated in approximately 40 months of the study)
measure: Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population
timeFrame: During index hospitalization maximum of 418 days (from the data evaluated in approximately 40 months of the study)
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Aleman
city: Caba
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: CEMIC
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Italiano
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba S.A.
city: Rosario
country: Argentina
facility: Sanatorio Britanico S.A.
city: Vienna
country: Austria
facility: AKH - Medizinische Universität Wien
city: Belo Horizonte
country: Brazil
facility: Hospital Felício Rocho
city: Belo Horizonte
country: Brazil
facility: Hospital Vera Cruz
city: Curitiba
country: Brazil
facility: CEPETI - Centro de Estudos e Pesquisa em Emergências Médicas e Terapia Intensiva
city: Porto Alegre
country: Brazil
facility: Hospital Moinho de Ventos
city: Santa Maria
country: Brazil
facility: Hospital de Caridade de Santa Maria -HCAA
city: Cali
country: Colombia
facility: Centro médico Imbanaco
city: Manizales
country: Colombia
facility: Caja de Compensacion Familiar de Caldas / Confa
city: Medellin
country: Colombia
facility: Promotora Medica Las Americas SA
city: Medellin
country: Colombia
facility: IPS Universitaria
city: Angers
country: France
facility: CHU Angers - Hôpital Hôtel Dieu
city: Nantes
country: France
facility: CHU Nantes - Hôtel Dieu pt
city: Paris
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
city: Paris
country: France
facility: Hôpital Bichat - Claude Bernard
city: Tourcoing
country: France
facility: Centre Hospitalier de Tourcoing
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
city: Jena
country: Germany
facility: University Hospital Jena
city: Patras
country: Greece
facility: University of Patras Medical School
state: Achaia
city: Athens
country: Greece
facility: General Hospital of Athens Laiko
state: Attiki
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
state: Roma
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
city: Genoa
country: Italy
facility: Azienda Ospedaliero Universitaria San Martino
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Torino
country: Italy
facility: Ospedale Amedeo di Savoia
city: Krasnodar
country: Russian Federation
facility: Regional Clinical Hospital #1
city: Moscow
country: Russian Federation
facility: SBIH of Moscow City Clinical Hospital # 7
city: Moscow
country: Russian Federation
facility: FSBI "State Scientific Centre of Coloproctology" of the MoH of RF
city: Moscow
country: Russian Federation
facility: FSBI "Hematological Research Center" MoH of RF
city: Saint-Petersburg
country: Russian Federation
facility: North-West Federal Medical Research Center n.a. V.A. Almazov
city: Ufa
country: Russian Federation
facility: SBIH Republican Clinical Hospital n.a. G. G. Kuvatov
city: Vigo
country: Spain
facility: Complexo Hospitalario Universitario de Vigo
state: Pontevedra
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Hopsital Ramón y Cajal
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
state: Greater Manchester
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals
state: South Yorkshire
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: