Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04170309 |
| Other study ID # |
BPR-PAS-001 |
| Secondary ID |
EUPAS30444 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 30, 2020 |
| Est. completion date |
June 9, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
Advanz Pharma |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Rationale and background:
Ceftobiprole is a beta-lactam antibiotic with bactericidal activity against a broad spectrum
of Gram-positive and Gram-negative bacteria, that was developed to treat patients with
pneumonia both in a hospital or community setting. Clinical trials were conducted in adult
immune-competent patients with normal or mild to moderate renal or hepatic function
impairment. The clinical trial program completed to date has excluded patients with immune
suppression and significant organ function impairment (hepatic or renal). The safety profile
of ceftobiprole in these patient groups was recognized during the marketing authorization
procedure as important missing information and the applicant committed to conduct a post
authorization safety study.
A randomized Phase 3 study in the indication of acute bacterial skin and skin structure
infections (ABSSSIs) is completed (NCT03137173), and a randomized Phase 3 study in the
indication of S. aureus bacteremia is ongoing (NCT03138733). This retrospective chart review
is conducted to further evaluate the safety profile of ceftobiprole in patient populations
with specific risk factors.
Research question:
To estimate the proportion and the relative frequency of treatment-emergent adverse events
(AEs) and adverse event of special interest will be assessed in patients treated with
ceftobiprole and who have at least one of the following conditions:
- Impaired renal function
- Impaired hepatic function
- Immunosuppression
Treatment-emergent AEs are defined as events occurring after first study-drug administration,
up to 28 days after the completion of treatment.
Adverse Events of Special Interest are the following;
- Hyponatraemia
- Hepatobiliary disorders
- Renal toxicity (including potential interactions with nephrotoxic drugs)
- Coombs test (DAT) positivity + clinical evidence of haemolysis
- Hypersensitivity reactions, including anaphylactic reactions
- Pseudomembranous colitis / C. difficile colitis
- Convulsions
The observed frequency of adverse events and adverse events of special interest in patients
with the above risk factors will be compared to the frequency of these adverse events and
adverse events of special interest in patients without these risk factors.
The study will enroll patients in whom treatment with ceftobiprole has been completed.
Patient charts will be selected from hospital sentinel sites.
Patient observation would normally be planned for 28 days after completion of ceftobiprole
therapy. If, at the time of the review of any patient medical records, an AE has not been
resolved, these patients would be followed up until resolution.
The study would continue until the target number of patients has been reached. The end date
of this study would be set at the date of the last patient record review, or in cases where
follow-up is extended beyond this period, until the end of follow-up.
Variables:
The following variables will be identified from the patient charts
- Year of birth and gender
- Weight
- Indication of treatment
- Attribution to a specific population group (see inclusion criteria) and criteria to
assign the patient
- Start date of ceftobiprole
- Stop date of ceftobiprole and main reason for stopping (if known)
- Prescribed dose/regimen at treatment start
- Changes in dose during treatment
- Relevant medical history (diagnosis within 1 year prior to treatment start)
- Presence of ascites and hepatic encephalopathy at baseline
- Laboratory investigations undertaken as part of routine clinical practice and management
of the patient related to the outcomes of interest, e.g., serum sodium, AST (aspartate
aminotransferase), ALT (alanine aminotransferase), serum albumin, total bilirubin, GGT
(gamma-glutamyltransferase) and AP (alkaline phosphatase), prothrombin time, INR
(international normalized ratio), creatinine, haemoglobin, HCT (hematocrit), Coombs
(DAT), C. difficile toxin tests prior (within 1 month) and up to 28 days after
completion of treatment
- Findings of colonoscopy/sigmoidoscopy (for C. difficile colitis)
- Concomitant medication at baseline and up to 28 days after completion of treatment with
focus on new onset use or dose modification of medications to treat
hypersensitivity/anaphylaxis, convulsions, or C. difficile colitis
- Treatment-emergent AEs (event reports up to 28 days after completion of treatment), with
focus on AEs of special interest (AESIs)
- Date and cause(s) of death (if applicable)
- Use during pregnancy (with follow-up until delivery)
Data sources:
This study will use data from patient charts, which includes physician and nurse notes,
admission and discharge summaries, consultancy reports, laboratory test sheets, and
microbiology sheets.
