A Study of Doripenem in Infants Less Than 12 Weeks of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01381848
First received: April 21, 2011
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to measure drug levels of doripenem in blood samples collected before and after administration of doripenem to infants less than 12 weeks of age who are hospitalized and documented, presumed to have, or are at risk for bacterial infection (s) and are undergoing treatment with intravenous (i.v.) antibiotics. Safety and tolerability will also be assessed.


Condition Intervention Phase
Bacterial Infections
Drug: Doripenem
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Doripenem in Infants (Term and Preterm), Less Than 12 Weeks Chronological Age

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Doripenem concentrations in blood samples [ Time Frame: Before and after study drug administration for 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: Up to Day 7 ] [ Designated as safety issue: No ]
  • Changes in clinical laboratory test results [ Time Frame: From Day -2 to Day 1 ] [ Designated as safety issue: No ]
  • Changes in vital signs measurements [ Time Frame: From Day -2 to Day 1 ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: October 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
Doripenem Type=exact number unit=mg/kg number=5 form=solution for injection route=intravenous use once on Day 1 for patients <8 weeks CA.,Doripenem Type=exact number unit=mg/kg number=8 form=solution for injection route=intravenous use once on Day 1 for patients >=8 weeks CA.
Drug: Doripenem
Type=exact number, unit=mg/kg, number=5, form=solution for injection, route=intravenous use, once on Day 1 for patients <8 weeks CA.
Drug: Doripenem
Type=exact number, unit=mg/kg, number=8, form=solution for injection, route=intravenous use, once on Day 1 for patients >=8 weeks CA.

Detailed Description:

This is a multicenter, open-label (identity of treatment is known to patient's parent/legal guardian/caregiver and to all study staff) pharmacokinetic study (a study to observe how the drug is absorbed and distributed within the body) to measure drug levels of doripenem in hospitalized but medically stable infants (term and preterm), <12 weeks of chronological age (CA) (age since time of birth) who have documented, presumed to have, or are at risk for bacterial infection(s) and are undergoing treatment with intravenous (i.v.) (administered in a vein) antibiotics. Doripenem will be administered alone at any time after the first dose of a nonstudy antibiotic is administered to the patient. Doripenem is not being used in this study to treat infection and it will not replace the patient's prescribed antibiotic(s). The duration of the study will be up to 9 days for each patient. Patients' safety will be monitored throughout the study by a safety committee who will review safety information at least once a month or after every 8 patients are enrolled and dosed. Safety evaluation will include, but will not be limited to, adverse events, clinical laboratory tests, and vital signs. A single dose of study drug (doripenem) will be administered to patients in a hospitalized setting. Patients <8 weeks CA will receive a 5 mg/kg doripenem 1-hour i.v. infusion, and patients >=8 weeks CA will receive an 8 mg/kg doripenem 1-hour infusion. Study drug will be administerd to the patient alone at any time after the first dose of a nonstudy antibiotic is administered to the patient.

  Eligibility

Ages Eligible for Study:   up to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be hospitalized, medically stable, without acute decline in physical condition in the inestigator's judgement
  • Documented, presumed to have, or are at risk for bacterial infection(s) and are undergoing treatment with i.v. antibiotics
  • Patient's weight (kg) must be within the 5th and the 95th percentile inclusive for his or her age
  • Parent or the patient's legally acceptable representative must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to allow the infant to participate in the study

Exclusion Criteria:

  • Clinically significant abnormal values for hematology or clinical chemistry at screening as deemed appropriate by the investigator
  • Clinically significant abnormal physical examination or vital signs at screening, as deemed appropriate by the investigator
  • Patients who, in the investigator's judgment, have compromised renal (kidney) function including renal failure
  • History of clinically significant allergies to medications, especially known hypersensitivity or intolerance to carbapenems, penicillins, or other beta lactam antibiotics
  • Known allergy to heparin or history of heparin-induced thrombocytopenia, if an indwelling cannula (e.g., heparin lock) or central line is used
  • Patients concomitantly treated with or having received imipenem/cilastin within 48 hours before study drug administration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381848

Locations
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Orange, California, United States
United States, Michigan
Royal Oak, Michigan, United States
United States, New Jersey
New Brunswick, New Jersey, United States
United States, Ohio
Toledo, Ohio, United States
United States, Texas
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Belgium
Leuven, Belgium
United Kingdom
Chertsey, United Kingdom
Exeter, United Kingdom
Liverpool, United Kingdom
Manchester, United Kingdom
Norwich, United Kingdom
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01381848     History of Changes
Other Study ID Numbers: CR016192, DORIPED1003
Study First Received: April 21, 2011
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration
Great Britain: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Janssen Research & Development, LLC:
Doripenem
DORIPED1003
Intravenous
Infection
Colonization
Prophylaxis
Pediatric
Antibiotic
Pharmacokinetics

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on July 20, 2014