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NCT Number: NCT03439124

Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia

This was a study of the safety and efficacy of ceftobiprole medocaril compared with intravenous (IV) standard-of-care cephalosporin treatment with or without vancomycin in pediatric patients with either hospital-acquired bacterial pneumonia (HAP) or community-acquired bacterial pneumonia (CAP) requiring hospitalization, and requiring intravenous (IV) antibiotic therapy.

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Key information

Conditions

Community-Acquired Pneumonia (CAP) Community-Acquired Infections Community-Acquired Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Hospital-acquired Pneumonia (HAP) Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

3 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Bulgaria

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About this study

This was a randomized, investigator-blind, active-controlled multi-center study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ceftobiprole medocaril compared with IV standard-of-care cephalosporin treatment with or without vancomycin in pediatric patients aged 3 months to less than 18 years with HAP or CAP requiring hospitalization and therapy with IV antibiotics. Randomization was stratified by four age groups (3 months to < 2 years; 2 years to < 6 years; 6 years to < 12 years; 12 years to < 18 years), and by diagnosis of HAP or CAP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male of female aged 3 months to < 18 years with a body weight of at least 5 kg
  • Diagnosis of either hospital-acquired pneumonia or community-acquired pneumonia requiring hospitalization and administration of IV antibiotic therapy
  • New or progressive imaging findings consistent with bacterial pneumonia
  • Requirement for IV antibacterial treatment for pneumonia
  • Other inclusion criteria may apply

Exclusion criteria

  • Known resistance of the causative pathogen to ceftobiprole or IV standard-of-care cephalosporin treatment (± vancomycin)
  • On mechanical ventilation
  • Chest trauma with severe lung contusion or flail chest
  • Acute respiratory distress syndrome
  • Empyema or lung abscess
  • Anatomical bronchial obstruction
  • Active or currently treated pulmonary tuberculosis
  • Atypical bacterial pneumonia, or viral pneumonia without bacterial superinfection, or need for antibiotic coverage with a macrolide
  • Pertussis, chemical pneumonitis, or cystic fibrosis
  • Severe immunodeficiency
  • Significant laboratory abnormalities including: Hematocrit <20%; absolute neutrophil count <0.5x10⁹/L; platelet count <50x10⁹/L; alanine aminotransferase, aspartate aminotransferase, or bilirubin >5 times the age-specific upper limit of normal;
  • Creatinine clearance <50 mL/min/1.73 m²
  • Use of systemic antimicrobial therapy for more than 24 hours in the 48 hours before randomization
  • History of a previous clinically-relevant hypersensitivity or serious adverse reaction to beta lactam antibiotics or to vancomycin
  • Poorly controlled seizure disorder
  • Other exclusion criteria may apply

Treatment and study plan

ceftobiprole medocaril

Drug

Ceftobiprole medocaril was administered at age-adjusted doses (10, 15 or 20 mg/kg) and infusion durations (2 or 4 hours) every 8 hours. The maximum dose, regardless of body weight, was 500 mg ceftobiprole every 8 hours (maximum total daily dose of 1500 mg ceftobiprole).

After a minimum of 3 days of IV treatment, patients with sufficient improvement in disease signs and symptoms could be switched to an age-appropriate oral antibiotic to complete a total minimum of 7 days and a total maximum of 14 days' antibiotic treatment.

Other names: ceftobiprole

IV standard-of-care cephalosporin

Drug

Ceftriaxone was administered at 50 to 80 mg/kg IV as a single daily dose, up to a maximum dose of 2 g/day. The actual dose of ceftriaxone within this dose range was determined by the blinded investigator prior to first study drug administration and was not modified during subsequent study days.

After a minimum of 3 days of IV treatment, patients with sufficient improvement in disease signs and symptoms could be switched to an age-appropriate oral antibiotic to complete a total minimum of 7 days and a total maximum of 14 days' antibiotic treatment.

At the discretion of the blinded investigator, patients received vancomycin at a dose of 10 to 15 mg/kg IV every 6 hours, up to a maximum dose of 2 g/day, in addition to the IV standard-of-care cephalosporin when MRSA was suspected or confirmed.

Primary outcomes

  1. Adverse Events

    Time frame: Analysis of AEs assessed during the first 3 days of IV therapy and while on IV, a median of 7 days

    Reported are adverse events (AEs) during the first 3 days of IV therapy and while patients were on IV therapy irrespective of when they switched to oral antibiotic treatment.

Secondary outcomes

  1. Proportion of Patients With Clinical Cure in the Intent-to-treat Population (ITT)

    Time frame: At the test-of-cure (TOC) visit

    Comparison of clinical cure rates (signs and symptoms of pneumonia normalized or improved such that no further antibiotic therapy was necessary, and stabilization or improvement of chest X-ray findings if these were available) in the ITT population between ceftobiprole and the comparator at the TOC visit.

  2. Proportion of Patients With Clinical Cure in the Clinically Evaluable (CE) Population

    Time frame: At the TOC visit

    Comparison of clinical cure rates (signs and symptoms of pneumonia normalized or improved such that no further antibiotic therapy was necessary, and stabilization or improvement of chest X-ray findings if these were available) in the CE population between ceftobiprole and the comparator at the TOC visit.

  3. Proportion of Patients With Early Clinical Response in the Intent-to-treat (ITT) Population

    Time frame: At Day 4

    Comparison of early clinical response rates in the ITT population between ceftobiprole and the comparator at Day 4.

  4. Proportion of Patients With Early Clinical Response in the Clinically Evaluable (CE) Population

    Time frame: At Day 4

    Comparison of early clinical response rates in the CE population between ceftobiprole and the comparator at Day 4.

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Registry information

Official study title

A Multicentre, Randomized, Investigator-blind, Active-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Ceftobiprole Versus Intravenous Standard-of-care Cephalosporin Treatment With or Without Vancomycin in Pediatric Patients Aged From 3 Months to Less Than 18 Years With Hospital-acquired Pneumonia or Community-acquired Pneumonia Requiring Hospitalisation

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 20, 2018
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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