Open-Label, Dose-Finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Patients With Suspected or Confirmed Bacterial Infections
The purpose of this Phase 1 trial is to evaluate the PK, safety and tolerability of oritavancin in patients <18 years old with a confirmed or suspected bacterial infection.
Study Start Date
Estimated Completion Date
- Drug: Oritavancin
- Pediatrics: Clinical Pharmacology,Peds Infectious Disease
- Infectious Disease: Antimicrobials,Peds Infectious Disease
- Pharmacy: Antimicrobials
- Bacterial Infections
- Gram-Positive Bacterial Infections
The Medicines Company -- TMC-ORI-11-01
The Medicines Company
- Males and females <18 years of age
- Neonates must be at least 34 weeks post-conception age
- Parent or legal guardian has given informed consent, as appropriate and pediatric patient has given verbal assent where appropriate.
- Suspected or confirmed Gram positive bacterial infection receiving antibiotic therapy
- Intravenous access to administer study drug
- In the investigator's opinion, the patient will require hospitalization for at least 24 hours after the study drug is administered.
- Septic shock or acute haemodynamic instability.
- History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, televancin, or teicoplanin) or any of their excipients.
- Currently using vancomycin or other glycopeptides
- Females who are of childbearing potential and unwilling to practice abstinence or use at least two methods of contraception or female patients of childbearing who are lactating or have a positive pregnancy test result at screening
- Males who are unwilling to practice abstinence or use an acceptable method of birth control during the entire study period
- Any surgical or medical condition which, in the opinion of the investigator, would put the patient at increased risk or is likely to interfere with study procedures or PK of the study drug.
- Patients whom the investigator considers unlikely to adhere to the protocol, comply with study drug administration, or complete the clinical study
- 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.
- 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.
18 Years and younger
Accepts Healthy Volunteers
Study Locations and Contact Information (9)
|Stony Brook University Medical Center - Stony Brook, New York||22.8 miles||Denise Ferraro FNPfirstname.lastname@example.org|
|Rainbow Babies and Childrens Hospital - Cleveland, Ohio||434.6 miles||Susan Bergant RNemail@example.com|
|Toledo Childrens Hospital - Toledo, Ohio||538.2 miles||Mary Thomas||419-291-2191||Mary.Thomas3@ProMedica.org|
|Kosair Charities Pediatric Clinical Research Unit - Louisville, Kentucky||696.1 miles||None||None||None|
|Arkansas Childrens Hospital - Little Rock, Arkansas||1,128.3 miles||Robin Gibson RNfirstname.lastname@example.org|
|University of Nebraska Medical Center - Omaha, Nebraska||1,182.2 miles||Jenny Goodwinemail@example.com|
|Rady Childrens Hospital San Diego - San Diego, California||2,469.3 miles||Sara Hingtgen RN MSNfirstname.lastname@example.org|
|CHOC Childrens - Orange, California||2,477.9 miles||Claudia Enriquez||714-509-4791||cenriquez@CHOC.ORG|
|HarbourUCLA Medcial Center - Torrance, California||2,499.6 miles||Samantha J Eells MPHemail@example.com|