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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01381848

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infections	Drug: Doripenem Drug: Doripenem	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Doripenem concentrations in blood samples [Before and after study drug administration for 1 day]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 12 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country
1	Little Rock	Arkansas	United States
2	Orange	California	United States
3	Royal Oak	Michigan	United States
4	New Brunswick	New Jersey	United States
5	Toledo	Ohio	United States
6	Houston	Texas	United States
7	Salt Lake City	Utah	United States
8	Leuven		Belgium
9	Chertsey		United Kingdom
10	Exeter		United Kingdom
11	Liverpool		United Kingdom
12	Manchester		United Kingdom
13	Norwich		United Kingdom