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OpenTrials
Completed

NCT Number: NCT00942149

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

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

48 hour–120 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 48 hours and <120 days of age at the time of daptomycin administration
  • Sufficient venous access to permit administration of study medication
  • Suspected to have systemic infection and appropriate cultures (blood +/- urine/CSF) are obtained within 72 hours of study entry
  • Availability and willingness of the parent/legally authorized representative to provide written informed consent

Exclusion criteria

  • History of anaphylaxis attributed to daptomycin
  • Previous participation in the study
  • Exposure to daptomycin in the month prior to the study
  • Serum creatinine >1.0 mg/dL
  • Concomitant administration of tobramycin

Treatment and study plan

daptomycin

Drug

single dose of 6 mg/kg of daptomycin

Primary outcomes

  1. PK of Daptomycin

    Time frame: 24 hours

    Area under the curve

Secondary outcomes

  1. Adverse Events Will be Monitored.

    Time frame: 7 days following last dose of study drug

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 20, 2009
Registry last updated
Jul 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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