Trial · NCT02424734
Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis
NCT02424734, Phase 2, Terminated, Pfizer; results first posted 2018-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis. Trials, record NCT02424734. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02424734
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis
- NCT number
- NCT02424734
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Late-onset Sepsis
- Interventions
- Ceftaroline Fosamil, Ampicillin, Aminoglycoside
- First posted
- 2015-04-23
- Last updated
- 2018-09-13
- Other registries' IDs
- eudract:2014-003243-34
- Results first posted
- 2018-07-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | 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. |
| Secondary | Plasma Concentration of Ceftaroline Fosamil | 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). |
| Secondary | Plasma Concentration of Ceftaroline | 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 |
| Secondary | Plasma Concentration of Ceftaroline M-1 | 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 |
| Secondary | Percentage of Participants With Favorable Clinical Response | 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. |
| Secondary | Percentage of Participants With Favorable Microbiological Response | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | Baseline up to SFU visit (up to a maximum study duration of 49 days) | Safety analysis set consisted of all enrolled participants for whom informed consent form was signed and received any amount of ceftaroline fosamil. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Concentration of Ceftaroline Fosamil | At the end of infusion (EOI) | Pharmacokinetic (PK) analysis set included all participants who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected. | ng/mL | NUMBER |
| SECONDARY | Plasma Concentration of Ceftaroline | At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI | PK analysis set included all participants who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected. | ng/mL | NUMBER |
| SECONDARY | Plasma Concentration of Ceftaroline M-1 | At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI | The PK analysis set will include all participants who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected. | ng/mL | NUMBER |
| SECONDARY | Percentage of Participants With Favorable Clinical Response | EOT visit (up to Day 15), TOC visit (up to Day 29) | Modified ITT analysis set: participants who received ceftaroline fosamil and met minimal disease criteria of late-onset sepsis (diagnosis of sepsis within 36 hours before enrolment \[defined as presence of \>=2 clinical criteria, \>=1 laboratory criteria in presence of or as a result of suspected /proven bacterial infection that requires IV therapy\]). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Favorable Microbiological Response | EOT visit (up to Day 15), TOC visit (up to Day 29) | Modified ITT analysis set: participants who received ceftaroline fosamil and met minimal disease criteria of late-onset sepsis (diagnosis of sepsis within 36 hours before enrolment \[defined as presence of \>=2 clinical criteria, \>=1 laboratory criteria in presence of or as a result of suspected /proven bacterial infection that requires IV therapy). | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | Ceftaroline Fosamil: Young Infants | AEs | 1 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | Ceftaroline Fosamil: Term Neonates | AEs | 3 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | Ceftaroline Fosamil: Preterm Neonates | AEs | 1 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | Ceftaroline Fosamil: Young Infants | SAEs | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | Ceftaroline Fosamil: Term Neonates | SAEs | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | Ceftaroline Fosamil: Preterm Neonates | SAEs | 1 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | Ceftaroline Fosamil: Young Infants | Discontinuations Due to AEs | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | Ceftaroline Fosamil: Term Neonates | Discontinuations Due to AEs | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | Ceftaroline Fosamil: Preterm Neonates | Discontinuations Due to AEs | 0 | Participants | |
| Plasma Concentration of Ceftaroline Fosamil | Ceftaroline Fosamil: All Participants | Participant 1 | 67.7 | ng/mL |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ceftaroline Fosamil: Young Infants | 4 | |
| Overall Study | STARTED | Ceftaroline Fosamil: Term Neonates | 5 | |
| Overall Study | STARTED | Ceftaroline Fosamil: Preterm Neonates | 2 | |
| Overall Study | Treated | Ceftaroline Fosamil: Young Infants | 4 | |
| Overall Study | Treated | Ceftaroline Fosamil: Term Neonates | 5 | |
| Overall Study | Treated | Ceftaroline Fosamil: Preterm Neonates | 2 | |
| Overall Study | COMPLETED | Ceftaroline Fosamil: Young Infants | 2 | |
| Overall Study | COMPLETED | Ceftaroline Fosamil: Term Neonates | 3 | |
| Overall Study | COMPLETED | Ceftaroline Fosamil: Preterm Neonates | 2 | |
| Overall Study | NOT COMPLETED | Ceftaroline Fosamil: Young Infants | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events27
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Ceftaroline Fosamil: Young Infants | 1 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | Ceftaroline Fosamil: Term Neonates | 1 | 5 | |
| other | Diarrhoea | Gastrointestinal disorders | Ceftaroline Fosamil: Preterm Neonates | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Ceftaroline Fosamil: Young Infants | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Ceftaroline Fosamil: Term Neonates | 0 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Ceftaroline Fosamil: Preterm Neonates | 1 | 2 | |
| other | Cerebral cyst | Nervous system disorders | Ceftaroline Fosamil: Young Infants | 0 | 4 | |
| other | Cerebral cyst | Nervous system disorders | Ceftaroline Fosamil: Term Neonates | 1 | 5 | |
| other | Cerebral cyst | Nervous system disorders | Ceftaroline Fosamil: Preterm Neonates | 0 | 2 | |
| other | Dermatitis | Skin and subcutaneous tissue disorders | Ceftaroline Fosamil: Young Infants | 0 | 4 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ceftaroline Fosamil: Young Infants | 0 | 4 |
| Total, all-cause mortality | Ceftaroline Fosamil: Term Neonates | 0 | 5 |
| Total, all-cause mortality | Ceftaroline Fosamil: Preterm Neonates | 0 | 2 |
| Total, other adverse events | Ceftaroline Fosamil: Young Infants | 1 | 4 |
| Total, other adverse events | Ceftaroline Fosamil: Term Neonates | 3 | 5 |
| Total, other adverse events | Ceftaroline Fosamil: Preterm Neonates | 1 | 2 |
| Total, serious adverse events | Ceftaroline Fosamil: Young Infants | 0 | 4 |
| Total, serious adverse events | Ceftaroline Fosamil: Term Neonates | 0 | 5 |
| Total, serious adverse events | Ceftaroline Fosamil: Preterm Neonates | 1 | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32091493 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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