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

• Conditions: Hospitalized but medically stable infants (term and preterm), <12 weeks CA, who have documented, presumed to have, or are at risk for bacterial infection(s) and are undergoing treatment with i.v. antibiotics.; MedDRA version: 14.0Level: LLTClassification code 10004044Term: Bacterial infection NOSSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2009-014387-20-Outside-EU/EEA
• Lead Sponsor: Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 48

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 48
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate the pharmacokinetics of doripenem after single-dose administration of doripenem to infants (term and preterm), <12 weeks chronological age (CA). Safety and tolerability will also be assessed.;Secondary Objective: N/A;Primary end point(s): Doripenem concentrations in blood samples;Timepoint(s) of evaluation of this end point: Before and after study drug administration for 1 day

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1 - Number of patients with adverse events<br>2 - Changes in clinical laboratory test results <br>3 - Changes in vital signs measurements;Timepoint(s) of evaluation of this end point: 1 - Up to Day 7<br>2 - From Day -2 to Day 1<br>3 - From Day -2 to Day 1