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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Estimation of the proportion and relative frequency of treatment-emergent AEs and AEs of special interest
Timeframe: during and until 28 days after completion of ceftobiprole therapy
Assessment of hyponatraemia
Timeframe: during and until 28 days after completion of ceftobiprole therapy
Assessment of hepatobiliary disorders
Timeframe: during and until 28 days after completion of ceftobiprole therapy
Assessment of renal toxicity (including potential interactions with nephrotoxic drugs)
Timeframe: during and until 28 days after completion of ceftobiprole therapy
Assessment of Coombs test (DAT) positivity + clinical evidence of haemolysis
Timeframe: during and until 28 days after completion of ceftobiprole therapy
Assessment of hypersensitivity reactions, including anaphylactic reactions
Timeframe: during and until 28 days after completion of ceftobiprole therapy
Assessement of Pseudomembranous colitis / Clostridium difficile colitis
Timeframe: during and until 28 days after completion of ceftobiprole therapy
Assessment of convulsions
Timeframe: during and until 28 days after completion of ceftobiprole therapy