Sepsis
Conditions
Keywords
Infants, Daptomycin
Brief summary
This is a safety and pharmacokinetic study of single-dose daptomycin in infants \> 48 hours and \< 120 days of age with suspected systemic infections. The investigators will enroll a total of 24 infants in 4 gestational age/postnatal age cohorts. Interim analyses will be performed after 3 infants are enrolled in each cohort. The investigators anticipate that 6 mg/kg of daptomycin will yield an AUC \<740 mch\*hr/mL.
Interventions
DRUGDaptomycin
single dose of 6 mg/kg of daptomycin
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
48 Hours to 120 Days
Healthy volunteers
No
Inclusion criteria
1. \> 48 hours and \<120 days of age at the time of daptomycin administration 2. Sufficient venous access to permit administration of study medication 3. Suspected to have systemic infection and appropriate cultures (blood +/- urine/CSF) are obtained within 72 hours of study entry 4. Availability and willingness of the parent/legally authorized representative to provide written informed consent
Exclusion criteria
1. History of anaphylaxis attributed to daptomycin 2. Previous participation in the study 3. Exposure to daptomycin in the month prior to the study 4. Serum creatinine \>1.0 mg/dL 5. Concomitant administration of tobramycin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK of Daptomycin | 24 hours | Area under the curve |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events Will be Monitored. | 7 days following last dose of study drug |
Countries
United States
Participant flow
Recruitment details
A total of 20 participants were enrolled in the Duke NICU over a period of 18 months.
Participants by arm
| Arm | Count |
|---|---|
| Daptomycin Cohort There were 20 participants enrolled; each received a single 6 mg/kg dose of daptomycin IV. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Daptomycin Cohort |
|---|---|
| Age, Categorical <=18 years | 20 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 0.1 years STANDARD_DEVIATION 0.1 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 20 |
| serious Total, serious adverse events | 3 / 20 |
Outcome results
Primary
PK of Daptomycin
Area under the curve
Time frame: 24 hours
Population: all 20 subjects were analyzed
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Area Under the Curve - 24 Hours | PK of Daptomycin | 262.4 mg*h/L | Full Range 0.005 |
Secondary
Adverse Events Will be Monitored.
Time frame: 7 days following last dose of study drug