Trial Outcomes & Findings for Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics (NCT NCT02527681)
NCT ID: NCT02527681
Last Updated: 2023-06-05
Results Overview
The maximum observed plasma concentration (Cmax)
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Blood samples for pharmacokinetic (PK) analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.
Results posted on
2023-06-05
Participant Flow
Subjects with documented or presumed bacterial infection receiving standard-of-care antibiotic treatment were screened.
Participant milestones
| Measure |
Ceftobiprole ITT/Safety Population
All subjects who received any quantity of study drug.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics
Baseline characteristics by cohort
| Measure |
Ceftobiprole ITT/Safety Population
n=15 Participants
All subjects who received any quantity of study drug.
|
|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
13 days
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples for pharmacokinetic (PK) analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.The maximum observed plasma concentration (Cmax)
Outcome measures
| Measure |
Ceftobiprole PK Population
n=13 Participants
All subjects who received study drug and had adequate samples for determination of time-plasma concentration profiles of ceftobiprole.
|
|---|---|
|
Cmax
|
11.2 μg/mL
Interval 8.68 to 32.6
|
PRIMARY outcome
Timeframe: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.The time of maximum observed plasma concentration (Tmax)
Outcome measures
| Measure |
Ceftobiprole PK Population
n=13 Participants
All subjects who received study drug and had adequate samples for determination of time-plasma concentration profiles of ceftobiprole.
|
|---|---|
|
Tmax
|
4.00 hours
Interval 4.0 to 4.0
|
PRIMARY outcome
Timeframe: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-last)
Outcome measures
| Measure |
Ceftobiprole PK Population
n=13 Participants
All subjects who received study drug and had adequate samples for determination of time-plasma concentration profiles of ceftobiprole.
|
|---|---|
|
AUC0-last
|
60.6 μg•hours/mL
Interval 49.1 to 126.0
|
PRIMARY outcome
Timeframe: Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing.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)
Outcome measures
| Measure |
Ceftobiprole PK Population
n=13 Participants
All subjects who received study drug and had adequate samples for determination of time-plasma concentration profiles of ceftobiprole.
|
|---|---|
|
T>MIC of 4 mg/L
|
5.40 hours
Interval 3.77 to 8.13
|
Adverse Events
Ceftobiprole ITT/Safety Population
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ceftobiprole ITT/Safety Population
n=15 participants at risk
All subjects who received any quantity of study drug.
|
|---|---|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
6.7%
1/15 • Number of events 1 • After start of study drug administration through the follow-up visit at study Day 7±3, relevant worsening of a subject's status was to be recorded as an adverse event (AE).
Once an AE was detected, it was proactively followed up at each visit (or more frequently if necessary) for any changes in severity, relationship to the study drug, interventions required for treatment, and the event's outcome. Serious adverse events (SAEs) were to be additionally reported and recorded on SAE report forms.
|
|
Nervous system disorders
Cerebral infarction
|
6.7%
1/15 • Number of events 1 • After start of study drug administration through the follow-up visit at study Day 7±3, relevant worsening of a subject's status was to be recorded as an adverse event (AE).
Once an AE was detected, it was proactively followed up at each visit (or more frequently if necessary) for any changes in severity, relationship to the study drug, interventions required for treatment, and the event's outcome. Serious adverse events (SAEs) were to be additionally reported and recorded on SAE report forms.
|
Other adverse events
| Measure |
Ceftobiprole ITT/Safety Population
n=15 participants at risk
All subjects who received any quantity of study drug.
|
|---|---|
|
Psychiatric disorders
Drug Dependence
|
6.7%
1/15 • Number of events 1 • After start of study drug administration through the follow-up visit at study Day 7±3, relevant worsening of a subject's status was to be recorded as an adverse event (AE).
Once an AE was detected, it was proactively followed up at each visit (or more frequently if necessary) for any changes in severity, relationship to the study drug, interventions required for treatment, and the event's outcome. Serious adverse events (SAEs) were to be additionally reported and recorded on SAE report forms.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
13.3%
2/15 • Number of events 2 • After start of study drug administration through the follow-up visit at study Day 7±3, relevant worsening of a subject's status was to be recorded as an adverse event (AE).
Once an AE was detected, it was proactively followed up at each visit (or more frequently if necessary) for any changes in severity, relationship to the study drug, interventions required for treatment, and the event's outcome. Serious adverse events (SAEs) were to be additionally reported and recorded on SAE report forms.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
1/15 • Number of events 1 • After start of study drug administration through the follow-up visit at study Day 7±3, relevant worsening of a subject's status was to be recorded as an adverse event (AE).
Once an AE was detected, it was proactively followed up at each visit (or more frequently if necessary) for any changes in severity, relationship to the study drug, interventions required for treatment, and the event's outcome. Serious adverse events (SAEs) were to be additionally reported and recorded on SAE report forms.
|
Additional Information
Project Physician
Basilea Pharmaceutica International Ltd.
Phone: +41 79 701 0551
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60