A clinical study to evaluate the pharmacokinetics, safety and tolerability of oritavancin in children less than 18 years old with a bacterial infection.
- Conditions
- Gram positive bacterial infectionMedDRA version: 17.1Level: LLTClassification code 10053021Term: Gram-positive bacterial infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 17.1Level: HLTClassification code 10004047Term: Bacterial infections NECSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 17.1Level: PTClassification code 10060945Term: Bacterial infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2013-005415-26-Outside-EU/EEA
- Lead Sponsor
- The Medicines Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 48
1. Males and females <18 years of age
2. Neonates must be at least 34 weeks post-conception age
3. Written informed consent before initiation of any study-related procedures. Parent or legal guardian has given informed consent, as appropriate; and pediatric subject has given verbal assent where appropriate.
4. Suspected or confirmed Gram positive bacterial infection receiving antibiotic therapy
5. Intravenous access to administer study drug
6. In the investigator’s opinion, the subject will require hospitalization for at least 24 hours after the study drug is administered.
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
1. Septic shock or acute haemodynamic instability.
2. History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, televancin, or teicoplanin) or any of their excipients.
3. Currently using vancomycin or other glycopeptides
4. Females who are of childbearing potential and unwilling to practice abstinence or use at least two methods of contraception (oral contraceptives, barrier methods, approved contraceptive implant) during the entire study period.
5. Female subjects of childbearing potential who are lactating or who have a positive pregnancy test result at screening coordinator, other staff or relative thereof directly involved in the conduct of the study.
6. Males who are unwilling to practice abstinence or use an acceptable method of birth control during the entire study period (i.e. condom with spermicide).
7. Any surgical or medical condition which, in the opinion of the investigator, would put the subject at increased risk or is likely to interfere with study procedures or PK of the study drug.
8. Subjects whom the investigator considers unlikely to adhere to the protocol, comply with study drug administration, or complete the clinical study (eg, unlikely to survive 60 days from initiation of study drug or unlikely to return for the Day 14 follow-up visit).
9. Treatment with investigational medicinal product or investigational device within 30 days (or 5 times the half-life of the investigational medicine, whichever is longer) before enrollment and for the duration of the study.
10. Subjects who are taking heparin or warfarin and/or require anticoagulant monitoring (aPTT, PT, INR).
11. Subjects with AST or ALT > 3xULN or total bilirubin = 2 ULN.
12. Neutropenia with absolute neutrophil count (ANC) <500 cells/mm3.
13. Any clinically significant disease or condition affecting a major organ system, including but not limited to gastrointestinal, renal, hepatic, endocrinologic, broncho-pulmonary, neurological, metabolic or cardiovascular disease.
14. Currently receiving cytotoxic chemotherapy or immunosuppressive therapy with tacrolimus or cyclosporine
15. Previous participation in this study
16. Subject is the child of the investigator or his/her deputy, research assistant, pharmacist, study
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 is the evaluation of pharmacokinetic profile (AUC and Cmax) after a single oritavancin infusion in pediatric subjects.;Secondary Objective: 1. The evaluation of pharmacokinetic profile (half-life [t1/2], tmax, volume of distribution [Vz], and CL) after a single oritavancin infusion in pediatric subjects.<br><br>2. Safety and tolerability assessments will be evaluated up to 60 days following the oritavancin infusion.;Primary end point(s): PK parameters (Cmax and area under the plasma concentration-time curve [AUC]);Timepoint(s) of evaluation of this end point: On Day 1, subjects will receive oritavancin and four PK samples will be collected over 24 hours. An additional three PK samples will be collected 48, 72, 336 hours after the infusion start time (total number of samples = 7).
- Secondary Outcome Measures
Name Time Method