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

January 8, 2013 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
  • United Kingdom
      • Chertsey, United Kingdom
      • Exeter, United Kingdom
      • Liverpool, United Kingdom
      • Manchester, United Kingdom
      • Norwich, United Kingdom
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Orange, California, United States
    • Michigan
      • Royal Oak, Michigan, United States
    • New Jersey
      • New Brunswick, New Jersey, United States
    • Ohio
      • Toledo, Ohio, United States
    • Texas
      • Houston, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Doripenem concentrations in blood samples
Time Frame: Before and after study drug administration for 1 day
Before and after study drug administration for 1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse events
Time Frame: Up to Day 7
Up to Day 7
Changes in clinical laboratory test results
Time Frame: From Day -2 to Day 1
From Day -2 to Day 1
Changes in vital signs measurements
Time Frame: From Day -2 to Day 1
From Day -2 to Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

June 24, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR016192
  • DORIPED1003 (Other Identifier: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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