Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis
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|ClinicalTrials.gov Identifier: NCT02424734|
Recruitment Status : Terminated (Study was terminated on 22Dec2017 due to slow enrollment; there were no safety or efficacy concerns.)
First Posted : April 23, 2015
Results First Posted : July 17, 2018
Last Update Posted : September 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Late-onset Sepsis||Drug: Ceftaroline Fosamil Drug: Ampicillin Drug: Aminoglycoside||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Multicentre Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Ceftaroline In Neonates And Young Infants With Late-onset Sepsis|
|Actual Study Start Date :||August 4, 2015|
|Actual Primary Completion Date :||December 26, 2017|
|Actual Study Completion Date :||December 26, 2017|
Experimental: Ceftaroline Fosamil
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
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.
Optional, will be given as per local standard of care.
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) [ Time Frame: Baseline up to SFU visit (up to a maximum study duration of 49 days) ]An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to study follow-up (SFU) visit (28 to 35 days after last dose of study treatment) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
- Plasma Concentration of Ceftaroline Fosamil [ Time Frame: At the end of infusion (EOI) ]Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above limit of quantification (LOQ). LOQ was 50 nanogram per milliliter (ng/mL).
- Plasma Concentration of Ceftaroline [ Time Frame: At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI ]Ceftaroline fosamil was the prodrug of ceftaroline. Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL
- Plasma Concentration of Ceftaroline M-1 [ Time Frame: At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI ]Ceftaroline M-1 was the inactive metabolite of ceftaroline. Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL
- Percentage of Participants With Favorable Clinical Response [ Time Frame: EOT visit (up to Day 15), TOC visit (up to Day 29) ]Clinical response was assessed by the investigator as Cure, Failure or Indeterminate at End of treatment (EOT) and Test of Cure (TOC). Favorable clinical response was defined as clinical response of Cure (defined as resolution of all acute signs and symptoms of Late-onset sepsis [LOS] or improvement to such an extent that no further antibacterial therapy is required). EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after the last dose of study therapy.
- Percentage of Participants With Favorable Microbiological Response [ Time Frame: EOT visit (up to Day 15), TOC visit (up to Day 29) ]Microbiological response was determining programmatically and assessed at the participants level at EOT and TOC. Microbiological response was defined as Favorable (Eradication or Presumed Eradication), Unfavorable (Persistence or Presumed Persistence) or Indeterminate (participant's clinical response is Indeterminate and no microbiological culture data is available). Eradication defined as absence of the original baseline pathogen from the source specimen; presumed eradication was defined when source specimen was not available to culture and the participant was assessed as a clinical cure (resolution of all acute signs and symptoms of LOS or improvement to such an extent that no further antibacterial therapy was required). EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after last dose of study drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424734
|United States, California|
|Rady Children's Hospital San Diego|
|San Diego, California, United States, 92123|
|Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet, Gyermekinfektologiai Osztaly|
|Budapest, Hungary, 1097|
|Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak, Gyermek-, Koraszulott es Csecsemoosztaly|
|Budapest, Hungary, 1125|
|Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Gyermekosztaly|
|Nyiregyhaza, Hungary, 4400|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|