Evaluating oritavancin for treating bacterial infections in children
An Open Label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of Oritavancin Single Dose Infusion in Pediatric Patients Less Than 18 Years of Age With Suspected or Confirmed Bacterial Infections (ORKIDS)
This study is testing a new antibiotic called oritavancin to see if it is safe and works well for children under 18 with certain bacterial infections.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Melinta Therapeutics, Inc. Industry-sponsored |
| Locations | 9 sites (Little Rock, Arkansas and 8 other locations) |
| Trial ID | NCT02134301 on ClinicalTrials.gov |
What this trial studies
This Phase 1 trial aims to assess the pharmacokinetics, safety, and tolerability of oritavancin in pediatric patients under 18 years old who have suspected or confirmed Gram-positive bacterial infections. The study will enroll approximately 54 patients across 5-10 centers in the US, utilizing a stepwise approach with five age cohorts starting from the older group. Patients will receive an intravenous dose of oritavancin, and safety and pharmacokinetic data will be collected to determine appropriate dosing for younger cohorts. Follow-up will include a 60-day phone call to caregivers to monitor safety outcomes.
Who should consider this trial
Good fit: Ideal candidates include males and females under 18 years of age with suspected or diagnosed Gram-positive bacterial infections.
Not a fit: Patients experiencing septic shock or those with a history of hypersensitivity to glycopeptides may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for pediatric patients with serious bacterial infections.
How similar studies have performed: Other studies have shown promise with similar antibiotic treatments in pediatric populations, but this specific approach with oritavancin is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 diagnosed Gram positive bacterial infection for which the subject is receiving standard antibiotic therapy; or peri-operative prophylactic use of antibiotics * Intravenous access to administer study drug * The subject will be observed in the emergency room or hospital for at least 1 hour after the study drug infusion is completed. Exclusion Criteria: * Septic shock or acute haemodynamic instability. * History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, dalbavancin, televancin, or teicoplanin) or any of their excipients. * Subjects who have taken vancomycin, telavancin, teicoplanin or other glycopeptide within 24 hours of screening or who are anticipated to need these drugs within 48 hours after administration of study drug. Subjects who have taken dalbavancin are excluded if taken within the previous 2 weeks or who are anticipated to need dalbavancin within 48 hours after administration of study drug. * 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.
Where this trial is running
Little Rock, Arkansas and 8 other locations
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (Completed)
- Childrens Hospital of Orange County — Orange, California, United States (Completed)
- Rady Children's Hospital — San Diego, California, United States (Recruiting)
- UCLA Harbor Medical Center — Torrance, California, United States (Completed)
- Univ of Louisville, Norton Children's Research Institute — Louisville, Kentucky, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- Stony Brook University Medical Center — Stony Brook, New York, United States (Withdrawn)
- Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States (Completed)
- Toledo Children's Hospital — Toledo, Ohio, United States (Terminated)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.