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Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis

Last updated on March 28, 2020

FOR MORE INFORMATION
Study Location
Rady Children's Hospital San Diego
San Diego, California, 92123 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Late-onset Sepsis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-59
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Informed consent in writing from parent(s) or other legally-acceptable
representative(s);

- Male or female, gestational age ≥34 weeks, and chronological age 7 to time of screening;

- Diagnosis of sepsis within 36 hours before enrolment, defined as the presence of at
least 2 clinical criteria and at least 1 laboratory criterion in the presence of or as
a result of suspected or proven bacterial infection that requires IV antibiotic
therapy;

- Patients must meet at least 2 of the following clinical criteria :Hypothermia ( OR fever (>38.5°C); Bradycardia OR tachycardia OR rhythm instability; Urine output 0.5
to 1 mL/kg/h OR hypotension OR mottled skin OR impaired peripheral perfusion;
Petechial rash OR sclerema neonatorum; New onset or worsening of apnoea episodes OR
tachypnoea episodes OR increased oxygen requirements OR requirement for ventilation
support; Feeding intolerance OR poor sucking OR abdominal distension; Irritability;
Lethargy; Hypotonia:

- Patients must meet at least 1 of the following laboratory criteria: White blood cell
count ≤4,000 × 109/L OR ≥20,000 × 109/L; Immature to total neutrophil ratio >0.2;
Platelet count ≤100,000 × 109/L; C-reactive protein (CRP) >15 mg/L OR procalcitonin ≥2
ng/mL; Hyperglycaemia OR Hypoglycaemia; Metabolic acidosis.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Documented history of any hypersensitivity or allergic reaction to any ?-lactam
antibiotic or aminoglycoside;

- At study entry, has confirmed infection with a pathogen known to be resistant to the
combination of ceftaroline fosamil, ampicillin, and the optional aminoglycoside of
choice OR confirmed viral, fungal, or parasitic pathogen as the sole cause of
infection;

- Refractory septic shock within 24 hours before enrolment that does not resolve after
60 minutes of vasopressor therapy;

- Moderate or severe renal impairment defined as serum creatinine ?2 times the upper
limit of normal (× ULN) for age OR urine output hours) OR requirement for dialysis;

- Evidence of progressively fatal underlying disease, or life expectancy of ?60 days;

- Documented history of seizure;

- Requiring or currently taking antiretroviral therapy for human immunodeficiency virus
(HIV) or a child from an HIV positive mother;

- Proven or suspected central nervous system (CNS) infection (eg, meningitis, brain
abscess, subdural abscess), osteomyelitis, endocarditis, or necrotizing enterocolitis
(NEC);

- Any condition (eg, cystic fibrosis, urea cycle disorders), antepartum/peripartum
factors, or procedures that would, in the opinion of the investigator, make the
patient unsuitable for the study, place a patient at risk, or compromise the quality
of data;

- Patient's parent(s) or legally-acceptable representative(s) involvement in the
planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff
at the study site). Concurrent participation in another clinical study with an
investigational product (IP), previous enrolment/participation in this study, or
participation in another study of ceftaroline fosamil within 14 days before the
intended start of the first dose of study therapy.

NCT02424734
Pfizer
Recruiting
Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis

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Late-onset Sepsis
NCT02424734
All Genders
0+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis
Official Title  ICMJE Open-label, Multicentre Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Ceftaroline In Neonates And Young Infants With Late-onset Sepsis
Brief Summary The purpose of this study is to evaluate the safety and tolerability of ceftaroline for the treatment of Late Onset Sepsis in neonates and young infants aged 7 to <60 days
Detailed Description

This is a multicentre, multinational, open-label, single treatment arm study of intravenous (IV) ceftaroline fosamil and ampicillin, plus an optional aminoglycoside of choice, in hospitalized neonates and young infants aged 7 to < 60 days with late-onset sepsis (LOS).

Baseline assessments for study eligibility will occur within 36 hours before administration of the first dose of study therapy. Study Day 1 is defined as the 24-hour period starting at the onset of the first administration of study therapy. Thereafter, subsequent Study Days are to follow the same pattern.

Safety assessments will occur throughout the study. Clinical outcome evaluations will occur at End-of-Therapy (EOT; within 24 hours after completion of last infusion) and Test-of-Cure (TOC; 8 to 15 days after the last dose of study therapy).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Late-onset Sepsis
Intervention  ICMJE
  • Drug: Ceftaroline Fosamil
    Ceftaroline fosamil will be given at a dose of 6 mg/kg IV over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour).
    Other Name: Zinforo, Teflaro
  • Drug: Ampicillin
    Ampicillin IV is required for the first 48 hours if the presence of an organism that requires treatment with ampicillin cannot be excluded. Will be given as per local standard of care.
  • Drug: Aminoglycoside
    Optional, will be given as per local standard of care.
Study Arms  ICMJE Experimental: Ceftaroline Fosamil
Ceftaroline Fosamil
Interventions:
  • Drug: Ceftaroline Fosamil
  • Drug: Ampicillin
  • Drug: Aminoglycoside
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 23, 2018)
11
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2015)
24
Actual Study Completion Date  ICMJE December 26, 2017
Actual Primary Completion Date December 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed consent in writing from parent(s) or other legally-acceptable representative(s);
  • Male or female, gestational age ?34 weeks, and chronological age 7 to <60 days at the time of screening;
  • Diagnosis of sepsis within 36 hours before enrolment, defined as the presence of at least 2 clinical criteria and at least 1 laboratory criterion in the presence of or as a result of suspected or proven bacterial infection that requires IV antibiotic therapy;
  • Patients must meet at least 2 of the following clinical criteria :Hypothermia (<36°C) OR fever (>38.5°C); Bradycardia OR tachycardia OR rhythm instability; Urine output 0.5 to 1 mL/kg/h OR hypotension OR mottled skin OR impaired peripheral perfusion; Petechial rash OR sclerema neonatorum; New onset or worsening of apnoea episodes OR tachypnoea episodes OR increased oxygen requirements OR requirement for ventilation support; Feeding intolerance OR poor sucking OR abdominal distension; Irritability; Lethargy; Hypotonia:
  • Patients must meet at least 1 of the following laboratory criteria: White blood cell count ?4,000 × 109/L OR ?20,000 × 109/L; Immature to total neutrophil ratio >0.2; Platelet count ?100,000 × 109/L; C-reactive protein (CRP) >15 mg/L OR procalcitonin ?2 ng/mL; Hyperglycaemia OR Hypoglycaemia; Metabolic acidosis.

Exclusion Criteria:

  • Documented history of any hypersensitivity or allergic reaction to any ?-lactam antibiotic or aminoglycoside;
  • At study entry, has confirmed infection with a pathogen known to be resistant to the combination of ceftaroline fosamil, ampicillin, and the optional aminoglycoside of choice OR confirmed viral, fungal, or parasitic pathogen as the sole cause of infection;
  • Refractory septic shock within 24 hours before enrolment that does not resolve after 60 minutes of vasopressor therapy;
  • Moderate or severe renal impairment defined as serum creatinine ?2 times the upper limit of normal (× ULN) for age OR urine output <0.5 mL/kg/h (measured over at least 8 hours) OR requirement for dialysis;
  • Evidence of progressively fatal underlying disease, or life expectancy of ?60 days;
  • Documented history of seizure;
  • Requiring or currently taking antiretroviral therapy for human immunodeficiency virus (HIV) or a child from an HIV positive mother;
  • Proven or suspected central nervous system (CNS) infection (eg, meningitis, brain abscess, subdural abscess), osteomyelitis, endocarditis, or necrotizing enterocolitis (NEC);
  • Any condition (eg, cystic fibrosis, urea cycle disorders), antepartum/peripartum factors, or procedures that would, in the opinion of the investigator, make the patient unsuitable for the study, place a patient at risk, or compromise the quality of data;
  • Patient's parent(s) or legally-acceptable representative(s) involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Concurrent participation in another clinical study with an investigational product (IP), previous enrolment/participation in this study, or participation in another study of ceftaroline fosamil within 14 days before the intended start of the first dose of study therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 59 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   United States
Removed Location Countries Italy,   Lithuania,   Spain
 
Administrative Information
NCT Number  ICMJE NCT02424734
Other Study ID Numbers  ICMJE D3720C00009
C2661002 ( Other Identifier: Alias Study Number )
2014-003243-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE PRA Health Sciences
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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