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

NCT00942149 | Completed Phase 1 Results

• 2 other identifiers: Pro00019311dapto1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

Infants; Daptomycin

Outcome Measures

Primary Outcomes (1)

• PK of Daptomycin

  Area under the curve

  24 hours

Secondary Outcomes (1)

• Adverse Events Will be Monitored.

  7 days following last dose of study drug

Study Arms (1)

Daptomycin cohort

EXPERIMENTAL

Drug: Daptomycin

Interventions

Daptomycin DRUG

single dose of 6 mg/kg of daptomycin

Daptomycin cohort

Eligibility Criteria

• Age: 48 Hours - 120 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Sepsis

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Brian Smith
• Organization: Duke University Medical Center

brian.smith@duke.edu

9196688951

Study Officials

• P Brian Smith, MD MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 20, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 15, 2013
• Results First Posted: December 12, 2012

Record last verified: 2013-06

Locations

US (1)