Clinical trial NCT02527681: Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics
Official title: An Open-label Study to Evaluate the Single-dose Pharmacokinetics and Safety of Ceftobiprole in Neonate and Infant Subjects Aged up to 3 Months Undergoing Treatment With Systemic Antibiotics
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Bacterial Infections
Lead sponsor: Basilea Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2015-08-19
Enrollment: 15
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.


Eligibility criteria: Inclusion Criteria:

* Neonates and infants ≤3 months, with gestational age ≥28 weeks
* 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:

* Major birth defect or malformation syndrome
* 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

Primary outcomes:
measure: Cmax
timeFrame: Blood samples for pharmacokinetic (PK) analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
measure: Tmax
timeFrame: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
measure: AUC0-last
timeFrame: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
measure: T>MIC of 4 mg/L
timeFrame: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: South Bend
country: United States
facility: Beacon Children's Hospital
state: Indiana
city: Louisville
country: United States
facility: Norton Children's Hospital
state: Kentucky
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Cancer Center at Magee-Womens Hospital
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Morgantown
country: United States
facility: West Virginia University School of Medicine
state: West Virginia
city: Leuven
country: Belgium
facility: UZ Leuven
city: Munich
country: Germany
facility: Klinikum der Universität München
city: Riga
country: Latvia
facility: Children Clinical University Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Children's Hospital
city: Kraków
country: Poland
facility: University Children's Hospital of Kraków
Study officials:
affiliation: Basilea Pharmaceutica
name: Marc Engelhardt, MD
role: STUDY_DIRECTOR
References:
citation: 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.