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 Protocol DORI-PED-1003; Phase 1

Phase 1

• 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: 12.0 Level: LLT Classification code 10004044 Term: Bacterial infection NOS

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-07
• Study Completion: 2012-04-30
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 52

Inclusion Criteria

1.Boy or girl <12 weeks CA
2.Subjects must be medically stable, without acute decline in physical condition in the investigator's judgment
3.A parent or the subject'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 child to participate in the study as described in Section 11.2.3, Informed Consent, and as approved by institutional-specific guidelines
4.Documented, presumed to have, or are at risk for bacterial infection(s) and are undergoing treatment with i.v. antibiotics
5.Subject's weight (kg) must be within the 5th and the 95th percentile inclusive for his or her age

Are the trial subjects under 18? yes
Number of subjects for this age range:
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

1.Clinically significant abnormal values for hematology or clinical chemistry at screening as deemed appropriate by the investigator. If the results of the chemistry or hematology tests are outside normal reference ranges for a subject’s age, even if considered to be clinically significant, the subject can be included if, in the investigator's judgment, the abnormalities are consistent with the subject's underlying disease(s) or therapies. This determination must be recorded in the subject’s source documents and initialed by the investigator.
2.Clinically significant abnormal physical examination or vital signs at screening as deemed appropriate by the investigator. If the results of the physical examination or vital signs are outside normal reference ranges for a subject’s age, even if considered to be clinically significant, the subject can be included if, in the investigator's judgment, the abnormalities are consistent with the subject's underlying disease(s) or therapies. This determination must be recorded in the subject’s source documents and initialed by the investigator.
3.Subjects who, in the investigator's judgment, have compromised renal function
4.History of clinically significant allergies to medications, especially known hypersensitivity or intolerance to carbapenems, penicillins, or other B lactam antibiotics
5.Known allergy to heparin or history of heparin-induced thrombocytopenia, if an indwelling cannula (e.g., heparin lock) or central line is used
6.Subjects concomitantly treated with or having received imipenem/cilastin within 48 hours before study drug administration
7.Subjects concomitantly treated with probenecid or VPA
8.Subjects with hematocrit levels <30% within 48 hours before study drug administration
9.Subjects who are anticipated to need a blood transfusion during the open-label phase of the study
10.Subjects who are fluid restricted to the extent that would not allow for necessary volume of study drug administration
11.Received an experimental drug or used an experimental medical device within 1 month or within a period <10 times the drug’s half-life, whichever is longer, before the first dose of the study drug is scheduled
12.Preplanned surgery or procedures that would interfere with the conduct of the study
13.Family member of the employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center

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): The primary objective of the study is to evaluate the pharmacokinetics of doripenem after single-dose administration of doripenem to infants (term and preterm), <12 weeks chronological age.