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
Conditions
Interventions
Trade Name: DORIBAX
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 364622-82-2
Current Sponsor code: JNJ38174942
Other descriptive name: DORIPENEM HYDRATE
Concentration unit: mg mil
Sponsors
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Boy or girl =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Belgium, United Kingdom
Outcome results
None listed