Collection of Data of Ceftobiprole Treated Patients: Comparison of Patients With and Without Certain Diseases

NCT04170309 | Completed

• 2 other identifiers: BPR-PAS-001EUPAS30444
• Study Type: observational
• Target: 428
• Locations: 4 countries
• Sites: 18

Brief Summary

In this observational study, data from patients treated with the antibiotic ceftobiprole in the past will be collected. The sponsor of the study is Correvio International Sárl, based in Switzerland. Correvio has committed to the health authorities to obtain further information on possible side effects especially in patients suffering from impaired liver or renal function or immune system deficiency and compare these effects to the ones observed in patients without these health problems. Patient data are collected from historic patient charts, patients will not be treated for the purpose of this data collection. All efforts are being made to capture the data of all patients who meet the inclusion criteria and have received at least one dose of ceftobiprole since this drug was first prescribed at the site.

Conditions

Renal Insufficiency; Hepatic Insufficiency; Immunosuppression

Keywords

Cephalosporins; Retrospective Studies; Safety

Outcome Measures

Primary Outcomes (8)

• Estimation of the proportion and relative frequency of treatment-emergent AEs and AEs of special interest

  during and until 28 days after completion of ceftobiprole therapy

• Assessment of hyponatraemia

  during and until 28 days after completion of ceftobiprole therapy

• Assessment of hepatobiliary disorders

  during and until 28 days after completion of ceftobiprole therapy

• Assessment of renal toxicity (including potential interactions with nephrotoxic drugs)

  during and until 28 days after completion of ceftobiprole therapy

• Assessment of Coombs test (DAT) positivity + clinical evidence of haemolysis

  during and until 28 days after completion of ceftobiprole therapy

• Assessment of hypersensitivity reactions, including anaphylactic reactions

  during and until 28 days after completion of ceftobiprole therapy

• Assessement of Pseudomembranous colitis / Clostridium difficile colitis

  during and until 28 days after completion of ceftobiprole therapy

• Assessment of convulsions

  during and until 28 days after completion of ceftobiprole therapy

Secondary Outcomes (3)

• Adverse events by indication

  during and until 28 days after completion of ceftobiprole therapy

• Treatment dosage

  During ceftobiprole therapy

• Treatment duration in days

  During ceftobiprole therapy

Study Arms (2)

With medical condition of interest

Participants treated with ceftobiprole with at least one of the following conditions: * Renal Insufficiency * Hepatic Insufficiency * Immunosuppression

Drug: Ceftobiprole medocaril

Without medical condition of interest

Patients treated with ceftobiprole without any of the following conditions: * Renal Insufficiency * Hepatic Insufficiency * Immunosuppression

Drug: Ceftobiprole medocaril

Interventions

Ceftobiprole medocaril DRUG

Participants in whom treatment with Ceftobiprole medocaril has been completed

With medical condition of interest; Without medical condition of interest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants from hospitals.

The study will enroll participants in whom treatment with ceftobiprole has been completed (including both on-label and off-label use) plus at least one of the following criteria (more than one criterion may apply): * Participants with severe renal impairment / ESRD (end-stage renal disease, defined as calculated CLCr ( creatinine clearance) \< 30 mL/minute or oliguria \< 20 mL/hour unresponsive to fluid challenge or any form of dialysis) * Impaired baseline hepatic function (patients with liver failure/cirrhosis Child Pugh Grade A, B, C or existing non-cirrhotic liver disease associated with total bilirubin \> 2 mg/dL or alanine aminotransferase \[ALT\], or aspartate aminotransferase \[AST\] ≥ 3 times upper limit of the normal range \[ULN\]) * Participants with immunosuppression, i.e., * HIV-positive with CD4 (cluster of differentiation 4) counts of ≤ 0.2 × 10E9/L (≤ 200 cells/mm3) * Immunocompromised as determined by the investigator (any type or aetiology) * Baseline neutropenia or baseline myelosuppression, defined as presence of myelosuppression or neutropenia (absolute neutrophil count \[ANC\] ≤ 0.5 × 10E9/L \[\< 500 polymorphonuclear neutrophils (PMNs)/mm3\]), severe anaemia (haemoglobin \< 6.5 g/dL), or severe thrombocytopenia (\< 49.9 × 10E9/mm3) In addition, the study will enroll a control group of patients in whom treatment has been completed without any of the criteria listed above.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Advanz Pharma: lead
• AMS Advanced Medical Services GmbH: collaborator
• APCER Life Sciences: collaborator

Study Sites (18)

Montpellier Hopital Lapeyronie

Montpellier, 34295, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, 34295, France

Location

Lungenklinik Neustadt GmbH

Neustadt/Harz, 99768, Germany

Location

Ospedale Sant'Orsola Malpighi

Bologna, 40138, Italy

Location

AORN Ospedali dei Colli - Ospedale 'V. Monaldi

Napoli, 80131, Italy

Location

Policlinico federico II

Napoli, 80131, Italy

Location

AO di Perugia -Ospedale Santa Maria della Misericordia

Perugia, 06129, Italy

Location

AOU Pisana-Cisanello

Pisa, 56124, Italy

Location

AAS n 5 "Friuli Occidentale - Ospedale Santa Maria degli Angeli

Pordenone, Italy

Location

AOU Città della Salute e della Scienza Torino - Presidio Molinette

Torino, 10126, Italy

Location

ASST Settelaghi - Ospedale di Circolo e Fondazione Macchi

Varese, Italy

Location

Hospital Clínic de Barcelona, Clinical Research Infectious Disease Department (CRID)

Barcelona, 08036, Spain

Location

Hospital Universitari MútuaTerrassa Planta 15

Barcelona, 08221, Spain

Location

Servei de Malalties Infeccioses Hospital Universitari Vall D'Hebron

Barcelona, 083035, Spain

Location

Hospital Universitario Virgen de las Nieves, 4ª Planta Izquierda

Granada, 18014, Spain

Location

Hospital Central de la Defensa "Gomez Ulla" Planta 22

Madrid, 28047, Spain

Location

Hospital La Moraleja

Madrid, 28050, Spain

Location

Hospital Universitario y Politécnico La Fe Servicio de Neumología. Torre E piso 4º

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Renal Insufficiency; Hepatic Insufficiency

Interventions

ceftobiprole medocaril

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Liver Diseases; Digestive System Diseases

Study Officials

• Noëlle Jemmely

  ADVANZ PHARMA Switzerland Sàrl

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: March 30, 2020
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); ES (7); IT (8); FR (2)