Pharmacokinetics (PK) and Safety Evaluation of Daptomycin in Children Ages 3-24 Months With Proven or Suspected Gram-positive Infections or Peri-Operative Subjects Receiving Prophylactic Antibiotics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01019395
First received: November 23, 2009
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 3 months to 24 months who have proven or suspected infections that are caused by a specific group of bacteria (called Gram-positive bacteria)or perioperative subjects that are receiving prophylactic antibiotics .


Condition Intervention Phase
Gram Positive Bacterial Infection
Drug: Daptomycin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged 3 Months to Twenty-Four Months Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Bacterial Infection Including Peri-Operative Prophylactic Use of Antibiotics

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • PK of single dose daptomycin in subjects between 3 and 24 months who are receiving standard antibiotic therapy for a Gram-positive infection, including subjects that are receiving prophylactic antibiotics peri-operatively. [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of a single dose daptomycin in subjects between 3 and 24 months, who are receiving standard antibiotic therapy for a Gram-positive infection, including subjects that are receiving prophylactic antibiotics peri-operatively. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: November 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Group 1: Ages 13 months to 24 months inclusive. Six subjects dosed at 6 mg/kg as a 30 minute infusion.
Drug: Daptomycin

Group 1: Ages 13 months to 24 months inclusive. Six subjects dosed at 6 mg/kg as a 30 minute infusion;

Group 2:Ages 7 months to 12 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion;

Group 3: Ages 3 months to 6 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion.

Other Name: Cubicin
Experimental: Group 2
Group 2: Ages 7 months to 12 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion
Drug: Daptomycin

Group 1: Ages 13 months to 24 months inclusive. Six subjects dosed at 6 mg/kg as a 30 minute infusion;

Group 2:Ages 7 months to 12 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion;

Group 3: Ages 3 months to 6 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion.

Other Name: Cubicin
Experimental: Group 3
Group 3: Ages 3 months to 6 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion.
Drug: Daptomycin

Group 1: Ages 13 months to 24 months inclusive. Six subjects dosed at 6 mg/kg as a 30 minute infusion;

Group 2:Ages 7 months to 12 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion;

Group 3: Ages 3 months to 6 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion.

Other Name: Cubicin

  Eligibility

Ages Eligible for Study:   3 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care; 2.1 Male or female between the ages of 3 months and 24 months, inclusive; 3. Able to comply with the protocol for the duration of the study; 4.1 Clinically stable with no evidence of hemodynamic instability (defined as a requirement for inotropic or vasodilatory support to manage blood pressure) in the 24 hour window prior to first dose, and no history or evidence of renal or hepatic compromise; 5.1 Suspected or diagnosed bacterial infection for which the subject is receiving standard antibiotic therapy; including prophylactic use of antibiotics peri-operatively; 6. A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as determined by the Schwartz equation at baseline; 7. Creatine phosphokinase (CPK) levels less than 2X ULN (upper limit of normal) at baseline; 8.1 Presence of two patent intravenous lines (or comparable means of venous or arterial access)prior to dosing on Study Day 1. A single intravenous line (or comparable means of venous access) is acceptable for both drug administration and sample collection if reasonable effort to gain a second line is unsuccessful. The line must be flushed as described in Appendix B of the protocol prior to obtaining PK samples. PK sample can be obtained from a peri-operatively placed arterial line. Arterial PK samples should be indicated on the CRF.

Exclusion Criteria:

  1. Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry;
  2. Known allergy/ hypersensitivity to daptomycin; 3.1 History of clinically significant, renal, hepatic, autoimmune disease or primary immune deficiency;

4. Deleted 5. Subjects with clinically significant abnormal laboratory test results (including ECGs), as determined by Investigator; 6. Administration of rifampin within 7 days of study drug administration; 7. Deleted 8. Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator); 9. Deleted; 10.1 Planned administration of intramuscular injection within 12 hours following study administration unless approved by the Medical Monitor; 11. Deleted 12.1 Guillian-Barre or spinal cord injury; 13. History of or current rhabdomyolysis.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019395

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Children's Hospital of Orange County
Orange, California, United States, 92868
Rady Children's Hospital-San Diego
San Diego, California, United States, 92123
United States, Louisiana
University of Louisiana at Monroe
Shreveport, Louisiana, United States, 71103
United States, Missouri
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Toledo Children's Hospital
Toledo, Ohio, United States, 43606
United States, Texas
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
Cubist Pharmaceuticals
Investigators
Study Director: Paula Bokesch, MD Cubist Pharmaceuticals
  More Information

No publications provided

Responsible Party: Cubist Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01019395     History of Changes
Other Study ID Numbers: DAP-PEDS-09-01
Study First Received: November 23, 2009
Last Updated: May 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
Gram Positive Infection
Concurrent Antibiotic Treatment

Additional relevant MeSH terms:
Bacterial Infections
Gram-Positive Bacterial Infections
Anti-Bacterial Agents
Daptomycin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on April 17, 2014