Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics
NCT ID: NCT02527681
Last Updated: 2023-06-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
15 participants
INTERVENTIONAL
2016-11-22
2020-02-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
NCT06086626
Vitality in Infants Via Azithromycin for Neonates Trial
NCT05763693
Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis
NCT03576560
Molecular Culture for the Diagnosis of Neonatal Sepsis
NCT05763680
Antimicrobial PK in Infants With Suspected or Confirmed Infection
NCT00491426
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ceftobiprole
Ceftobiprole medocaril is the water-soluble prodrug of ceftobiprole, an advanced-generation cephalosporin developed for intravenous administration. Ceftobiprole is characterized by potent, broad-spectrum antimicrobial activity against both Gram-positive and Gram-negative pathogens.
Ceftobiprole medocaril
Ceftobiprole medocaril was administered as a single intravenous infusion, with a bodyweight-adjusted volume, at a constant rate over 4 hours. The ceftobiprole dose was 7.5 mg/kg, which corresponds to 10.0 mg ceftobiprole medocaril.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ceftobiprole medocaril
Ceftobiprole medocaril was administered as a single intravenous infusion, with a bodyweight-adjusted volume, at a constant rate over 4 hours. The ceftobiprole dose was 7.5 mg/kg, which corresponds to 10.0 mg ceftobiprole medocaril.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Documented or presumed (or at risk of) bacterial infections, and currently receiving antibiotic treatment
* Expected to survive beyond the first 7 days after enrollment
* Sufficient vascular access to receive study drug, and to allow blood sampling at a site separate from the study drug infusion site
* Parent's / legally acceptable representative's informed consent to participate in the study
Exclusion Criteria
* Proven presence of an immunodeficiency
* HIV or other congenital viral or fungal infection
* Significant laboratory abnormalities including: hematocrit \<20%; absolute neutrophil count \<0.5x10⁹/L; platelet count \< 50x10⁹/L; alanine aminotransferase or aspartate aminotransferase \>3 times the age-specific upper limit of normal
* Impaired renal function or known significant renal disease
* Any condition which would make the subject or caregiver, in the opinion of the investigator, unsuitable for the study
3 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Basilea Pharmaceutica
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marc Engelhardt, MD
Role: STUDY_DIRECTOR
Basilea Pharmaceutica
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Loma Linda University Medical Center
Loma Linda, California, United States
University of Southern California
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Beacon Children's Hospital
South Bend, Indiana, United States
Norton Children's Hospital
Louisville, Kentucky, United States
Duke University Hospital
Durham, North Carolina, United States
University of Pittsburgh Medical Center Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
West Virginia University School of Medicine
Morgantown, West Virginia, United States
UZ Leuven
Leuven, , Belgium
Klinikum der Universität München
Munich, , Germany
Children Clinical University Hospital
Riga, , Latvia
Vilnius University Children's Hospital
Vilnius, , Lithuania
University Children's Hospital of Kraków
Krakow, , Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rubino CM, Polak M, Schropf S, Munch HG, Smits A, Cossey V, Tomasik T, Kwinta P, Snariene R, Liubsys A, Gardovska D, Hornik CD, Bosheva M, Ruehle C, Litherland K, Hamed K. Pharmacokinetics and Safety of Ceftobiprole in Pediatric Patients. Pediatr Infect Dis J. 2021 Nov 1;40(11):997-1003. doi: 10.1097/INF.0000000000003296.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-004614-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BPR-PIP-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.