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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

Primary Purpose

Gram Positive Bacterial Infection

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Daptomycin
Sponsored by
Cubist Pharmaceuticals LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Gram Positive Bacterial Infection focused on measuring Gram Positive Infection, Concurrent Antibiotic Treatment

Eligibility Criteria

3 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arkansas Children's Hospital
  • Children's Hospital of Orange County
  • Rady Children's Hospital-San Diego
  • University of Louisiana at Monroe
  • Children's Mercy Hospital and Clinics
  • University Hospitals Case Medical Center
  • Toledo Children's Hospital
  • Cook Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

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.

Outcomes

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.

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.

Full Information

First Posted
November 23, 2009
Last Updated
November 11, 2019
Sponsor
Cubist Pharmaceuticals LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01019395
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 5, 2010 (Actual)
Primary Completion Date
March 20, 2012 (Actual)
Study Completion Date
March 20, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cubist Pharmaceuticals LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram Positive Bacterial Infection
Keywords
Gram Positive Infection, Concurrent Antibiotic Treatment

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Group 1: Ages 13 months to 24 months inclusive. Six subjects dosed at 6 mg/kg as a 30 minute infusion.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Group 2: Ages 7 months to 12 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Group 3: Ages 3 months to 6 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion.
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Other Intervention Name(s)
Cubicin
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility 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: Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Bokesch, MD
Organizational Affiliation
Cubist Pharmaceuticals LLC
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Rady Children's Hospital-San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of Louisiana at Monroe
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Children's Mercy Hospital and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Toledo Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
25361023
Citation
Bradley JS, Benziger D, Bokesch P, Jacobs R. Single-dose pharmacokinetics of daptomycin in pediatric patients 3-24 months of age. Pediatr Infect Dis J. 2014 Sep;33(9):936-9. doi: 10.1097/INF.0000000000000318.
Results Reference
result

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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

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