Study of Single Dose Daptomycin in Pediatric Patients With Gram-positive Infection for Which They Are Receiving Standard Antibiotics

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ClinicalTrials.gov Identifier: NCT00136292

Recruitment Status : Completed

First Posted : August 29, 2005

Last Update Posted : March 11, 2020

Sponsor:

Information provided by (Responsible Party):

Cubist Pharmaceuticals LLC

Study Description

Brief Summary:

The purpose of this study is to evaluate the pharmacokinetics of a single dose of daptomycin in patients aged 2-17 years old who have a suspected or proven gram-positive infection for which they are receiving standard antibiotic therapy. The tolerability of a single dose of daptomycin in these patients will also be assessed.

Condition or disease	Intervention/treatment	Phase
Gram-positive Bacterial Infections	Drug: daptomycin	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	33 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Official Title:	An Evaluation of the Pharmacokinetics of a Single Dose of Daptomycin (4 mg/kg) in Pediatric Patients Aged Two to Seventeen Years Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-positive Infection
Actual Study Start Date :	August 24, 2005
Actual Primary Completion Date :	August 1, 2006
Actual Study Completion Date :	August 9, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Drug Information available for: Daptomycin

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Pharmacokinetic

Secondary Outcome Measures :

Tolerability

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	2 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

2-17 years old
Suspected or diagnosed gram-positive infection for which the patient is receiving standard antibiotic therapy
Clinically stable with no evidence of hemodynamic instability in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise, or clinically significant alterations in fluid/electrolyte homeostasis
Creatinine clearance (CLcr) ≥ 80 ml/min/1.73 m2 as determined by the Schwartz equation
Creatine phosphokinase (CPK) levels within normal limits

Exclusion Criteria:

Known allergy to daptomycin
History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, or autoimmune disease
Pneumonia as sole gram-positive infection
Use of HMG-CoA reductase inhibitors or other systemic anti-hyperlipidemic agents within 7 days prior to study drug administration and expected use through 3 days post-dose
Clinically significant abnormal laboratory test results (including electrocardiograms [ECGs]), as determined by Investigator
Body mass index (BMI) that is outside of the 5th to 95th percentile for age
History (personal or 1st degree relative) of clinically significant muscular disease, nervous system, seizure or psychiatric disorder
Expected intramuscular (IM) injection within 3 days following dosing
Expected surgical procedure(s) within 3 days following dosing
Unexplained muscular weakness
Rhabdomyolysis, myositis or septic shock

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136292

Locations

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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72202
United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390

Sponsors and Collaborators

Cubist Pharmaceuticals LLC

Investigators

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Principal Investigator:	Richard Jacobs, MD	University of Arkansas

More Information

Publications of Results:

Abdel-Rahman SM, Benziger DP, Jacobs RF, Jafri HS, Hong EF, Kearns GL. Single-dose pharmacokinetics of daptomycin in children with suspected or proved gram-positive infections. Pediatr Infect Dis J. 2008 Apr;27(4):330-4. doi: 10.1097/INF.0b013e318160edfc.

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Responsible Party:	Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier:	NCT00136292
Other Study ID Numbers:	3009-028 DAP-PEDS-05-01 ( Other Identifier: Cubist Study Number )
First Posted:	August 29, 2005 Key Record Dates
Last Update Posted:	March 11, 2020
Last Verified:	March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL:	http://engagezone.msd.com/ds_documentation.php

Keywords provided by Cubist Pharmaceuticals LLC:


Gram-Positive Infection

Additional relevant MeSH terms:

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Infection Communicable Diseases Bacterial Infections Gram-Positive Bacterial Infections	Daptomycin Anti-Bacterial Agents Anti-Infective Agents

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