A Study of Doripenem in Infants Less Than 12 Weeks of Age
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
2 other identifiers
interventional
52
3 countries
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2009
Typical duration for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 21, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJanuary 10, 2013
January 1, 2013
2.5 years
April 21, 2011
January 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Doripenem concentrations in blood samples
Before and after study drug administration for 1 day
Secondary Outcomes (3)
Number of patients with adverse events
Up to Day 7
Changes in clinical laboratory test results
From Day -2 to Day 1
Changes in vital signs measurements
From Day -2 to Day 1
Study Arms (1)
001
EXPERIMENTALDoripenem 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.
Interventions
Type=exact number, unit=mg/kg, number=5, form=solution for injection, route=intravenous use, once on Day 1 for patients \<8 weeks CA.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Orange, California, United States
Unknown Facility
Royal Oak, Michigan, United States
Unknown Facility
New Brunswick, New Jersey, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Leuven, Belgium
Unknown Facility
Chertsey, United Kingdom
Unknown Facility
Exeter, United Kingdom
Unknown Facility
Liverpool, United Kingdom
Unknown Facility
Manchester, United Kingdom
Unknown Facility
Norwich, United Kingdom
Related Publications (1)
Cirillo I, Vaccaro N, Castaneda-Ruiz B, Redman R, Cossey V, Bradley JS, Allegaert K. Open-Label Study To Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Doripenem in Infants Less than 12 Weeks in Chronological Age. Antimicrob Agents Chemother. 2015 Aug;59(8):4742-9. doi: 10.1128/AAC.00485-15. Epub 2015 May 26.
PMID: 26014957DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC C. Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2011
First Posted
June 27, 2011
Study Start
October 1, 2009
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
January 10, 2013
Record last verified: 2013-01