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CompletedNCT00942149Updated Jul 15, 2013Results posted

An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants

A Phase 1 interventional study of Daptomycin in Sepsis, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 48 Hours to 120 Days. Per ClinicalTrials.gov, last updated 2013-07-15.

Sponsored by Duke University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
48 Hours to 120 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Sepsis

Keywords

  • Infants
  • Daptomycin
03

In context

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
48 Hours to 120 Days
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Daptomycin cohort

    Drug: Daptomycin

Interventions

  • DrugDaptomycin

    single dose of 6 mg/kg of daptomycin

06

What researchers measure

Primary outcomes

  1. PK of Daptomycin

    Area under the curve

    Time frame: 24 hours

Secondary outcomes

  1. Adverse Events Will be Monitored.

    Time frame: 7 days following last dose of study drug

07

Results

Posted Dec 12, 2012

Participant flow

A total of 20 participants were enrolled in the Duke NICU over a period of 18 months.

Participant flow — Overall Study
MilestoneDaptomycin Cohort
Started20
Completed20
Not completed0

Outcome measures

PrimaryPK of Daptomycin

Area under the curve

Time frame:
24 hours
Reported as:
Median · mg*h/L
PK of Daptomycin
mg*h/LArea Under the Curve - 24 Hours
PK of Daptomycin262.4 ± .005
SecondaryAdverse Events Will be Monitored.
Time frame:
7 days following last dose of study drug

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Daptomycin Cohort—3/20 (15%)6/20 (30%)
Most frequent serious events
Most frequent serious events
EventDaptomycin Cohort
PneumatoceleRespiratory, thoracic and mediastinal disorders2/20
Abnormal KUBGastrointestinal disorders1/20
possible morgagni cdhRespiratory, thoracic and mediastinal disorders1/20
Most frequent other events
Most frequent other events
EventDaptomycin Cohort
patent foramen ovaleCardiac disorders2/20
unconjugated hyperbilirubinemiaBlood and lymphatic system disorders2/20
pulmonary edemaRespiratory, thoracic and mediastinal disorders2/20

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Daptomycin Cohort
<=18 years20
Between 18 and 65 years0
>=65 years0
Age Continuous
Age Continuous(years)Daptomycin Cohort
Mean0.1 ± 0.1
Sex: Female, Male
Sex: Female, Male(Participants)Daptomycin Cohort
Female10
Male10
Region of Enrollment
Region of Enrollment(participants)Daptomycin Cohort
United States20
08

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00942149
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Jul 20, 2009
Start date
Jan 2010
Primary completion
Dec 2011
Completion
Dec 2011
Results posted
Dec 12, 2012
Last update
Jul 15, 2013

Study contacts

P Brian Smith, MD MHS
principal investigator · Duke University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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