Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics

NCT02527681 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: BPR-PIP-0012013-004614-18
• Study Type: interventional
• Target: 15
• Locations: 6 countries
• Sites: 14

Brief Summary

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

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (4)

• Cmax

  The maximum observed plasma concentration (Cmax)

  Blood samples for pharmacokinetic (PK) analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.

• Tmax

  The time of maximum observed plasma concentration (Tmax)

  Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.

• AUC0-last

  The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-last)

  Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.

• T>MIC of 4 mg/L

  The duration of time after dose for which free-drug concentrations remained above a value of 4 mg/L (T\>MIC of 4 mg/L)

  Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.

Study Arms (1)

Ceftobiprole

EXPERIMENTAL

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.

Drug: Ceftobiprole medocaril

Interventions

Ceftobiprole medocaril DRUG

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.

Also known as: ceftobiprole

Ceftobiprole

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Basilea Pharmaceutica: lead

Study Sites (14)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

University of Southern California

Los Angeles, California, 90089, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Beacon Children's Hospital

South Bend, Indiana, 46601, United States

Location

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Duke University Hospital

Durham, North Carolina, 27705, United States

Location

University of Pittsburgh Medical Center Cancer Center at Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

West Virginia University School of Medicine

Morgantown, West Virginia, 26506-9214, United States

Location

UZ Leuven

Leuven, Belgium

Location

Klinikum der Universität München

Munich, Germany

Location

Children Clinical University Hospital

Riga, Latvia

Location

Vilnius University Children's Hospital

Vilnius, Lithuania

Location

University Children's Hospital of Kraków

Krakow, Poland

Location

Related Publications (1)

• 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.

  PMID: 34533489 DERIVED

MeSH Terms

Conditions

Bacterial Infections

Interventions

ceftobiprole medocaril; ceftobiprole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Project Physician
• Organization: Basilea Pharmaceutica International Ltd.

marc.engelhardt@basilea.com

+41 79 701 0551

Study Officials

• Marc Engelhardt, MD

  Basilea Pharmaceutica

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 19, 2015
• Study Start: November 22, 2016
• Primary Completion: February 25, 2020
• Study Completion: February 25, 2020
• Last Updated: June 5, 2023
• Results First Posted: January 6, 2021

Record last verified: 2023-05

Locations

PL (1); LA (1); BE (1); DE (1); US (9); LI (1)