Telavancin Pediatric PK Study (Ages >12 Months to 17 Years)

NCT02013141 | Terminated Phase 1 Results DMC

• 1 other identifier: 0101
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 7

Brief Summary

This is a multicenter, open-label, single-dose pharmacokinetic (PK) study. Infants, children, and adolescents will receive a single 10 mg/kg dose of telavancin infused intravenously (IV) over 60 minutes

Conditions

Gram-Positive Bacterial Infections

Keywords

Gram positive bacteria; Telavancin; VIBATIV; Pediatric; Pharmacokinetics

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetics- Area Under the Curve Extrapolated to Infinity for the Plasma Concentration Versus Time Curves for Telavancin

  Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin, and area under the curve extrapolated to infinity was calculated for the plasma concentration versus time curves for telavancin following a single 10 mg/kg IV dose.

  1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours

• Pharmacokinetics- Maximum Plasma Concentration of Telavancin

  Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin to provide the maximum plasma concentration of telavancin following a single 10 mg/kg IV dose.

  1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours

• Pharmacokinetics- Time to Maximum Plasma Telavancin Concentration

  Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin to provide the time to maximum plasma concentration of telavancin following a single 10 mg/kg IV dose.

  1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours

• Pharmacokinetics- Terminal Elimination Half-life for Plasma Telavancin

  Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin, and the terminal elimination half-life was calculated from the plasma concentration versus time curves for telavancin following a single 10 mg/kg IV dose.

  1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours

• Pharmacokinetics- Area Under the Curve From Time Zero to the Last Sample for the Telavancin Plasma Concentration Versus Time Curve

  Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin, and area under the curve from time zero to the last sample was calculated for the plasma concentration versus time curves for telavancin following a single 10 mg/kg IV dose.

  1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours

Secondary Outcomes (2)

• Safety- Number of Treatment-emergent Adverse Events.

  Day 0 (screening) through follow-up on Day 8 (+/- 1 day)

• Safety- Number of Subjects With Treatment-emergent Adverse Events

  Day 0 (screening) through follow-up on Day 8 (+/- 1 day)

Study Arms (1)

Telavancin

EXPERIMENTAL

Telavancin 10 mg/kg IV administered over approximately 60 minutes one time.

Drug: Telavancin

Interventions

Telavancin DRUG

Also known as: VIBATIV, TD-6424

Telavancin

Eligibility Criteria

• Age: 12 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject is \> 12 months to 17 years of age (inclusive)
• Subject's weight is within the 3rd to 97th percentile (inclusive) for age and sex.
• Written informed consent and assent (if appropriate for older age groups) has been obtained per institutional review board (IRB) policy and requirements, consistent with ICH guidelines.
• Male and female subjects of reproductive potential (i.e., post-pubertal males and post-menarche females) must agree to use a highly effective method of contraception throughout study period and for 30 days after administration of study drug. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \<1% per year) when used consistently and correctly, such as condom + diaphragm, condom + spermicide, diaphragm + spermicide; or intrauterine device (IUD) with documented failure rate of \<1% per year; or oral/injectable/implanted hormonal contraceptives used in combination with an additional double-barrier method; or sexual abstinence.
• Female subjects who are post menarche are required to have a negative serum pregnancy test before the administration of study drug.
• Subject requires or recently completed systemic antibiotic therapy for the treatment or prevention of a known or suspected bacterial infection. If completed, the last administered dose of systemic antibiotic must be within 24 hours of enrollment.

You may not qualify if:

• Subject has an estimated creatinine clearance \<50 mL/min/1.73 m2 (Schwartz equation).
• Any clinically significant abnormal laboratory value, including hematology, chemistry, or urinalysis that in the judgement of the investigator would make it difficult to assess the pharmacokinetic profile and safety of a single dose of telavancin or would compromise the safety of the subject.
• Any clinically significant medical history, abnormal physical examination finding, or vital sign measurement, including evidence of hemodynamic instability or significant collections of fluid outside normal vascular and tissue compartments (e.g., large pleural effusions, ascites), that in the judgement of the investigator would make it difficult to assess the pharmacokinetic profile or safety of a single dose of telavancin or would compromise the safety of the subject.
• Subject has clinically relevant cardiac abnormality, in the opinion of the investigator, such as:
• A mean QTcF \>440 msec, congenital long QT syndrome, second or third degree heart block at rest.
• Hemodynamically significant heart disease, eg, hemodynamically unstable congenital heart defect, uncompensated heart failure, uncorrected abnormal calcium, hyperkalemia, or any other unstable cardiac condition.
• An arrhythmic heart condition requiring medical therapy
• Subject is receiving an anticoagulant AND requires specific coagulation testing (Prothrombin Time/International Normalized Ratio, Activated Partial Thromboplastin Time, Activated Clotting Time, or Coagulation Based Factor X Activity Assay) within 24 hours of receiving the telavancin dose. NOTE: Although telavancin does not interfere with coagulation, it interferes with some assays used to monitor coagulation.
• Subjects who are receiving concomitant vancomycin treatment should not be assessed for vancomycin serum concentrations within 24 hours of receiving the Telavancin dose. NOTE: Telavancin might interfere with some Vancomycin therapeutic drug monitoring assays. Caution should be exercised when interpreting vancomycin drug monitoring levels in the presence of telavancin.
• Subject has a history of allergies or hypersensitivities to glycopeptide antibiotics (e.g., vancomycin), telavancin, or the formulation excipients.
• Subject requires, or is anticipated to require, concomitant \[within 24 hours before or 24 hours following the single dose of study medication (telavancin)\] administration of agents that in the clinical judgment of the investigator increase the risk of torsade de pointes.
• Subject is considered unlikely to comply with the study procedures.
• Subject was treated with an investigational drug within 30 days or five half-lives, whichever is longer, before study entry.
• Subject has any other condition that, in the opinion of an investigator, would confound or interfere with evaluation of safety of the investigational drug, or prevent compliance with the study protocol.

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (7)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Rutgers-Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Toledo Children's Hospital

Toledo, Ohio, 43606, United States

Location

Related Publications (1)

• Bradley JS, Goldman JL, James LP, Kaelin B, Gibson BHY, Arrieta A. Pharmacokinetics and safety of a single dose of telavancin in pediatric subjects 2-17 years of age. Antimicrob Agents Chemother. 2023 Nov 15;67(11):e0098723. doi: 10.1128/aac.00987-23. Epub 2023 Oct 10.

  PMID: 37815398 DERIVED

MeSH Terms

Conditions

Gram-Positive Bacterial Infections

Interventions

telavancin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

Information on the pharmacokinetics and safety of a single dose of telavancin in subjects aged 2 to 5 years is limited as Cohort 3 only enrolled 1 participant due to early termination of the study. No infants were enrolled due to early termination of the study, and therefore, no information is available on the pharmacokinetics and safety of a single dose of telavancin in infants.

Results Point of Contact

• Title: Clinical Scientist
• Organization: Cumberland Pharmaceuticals Inc

bgibson@cumberlandpharma.com

615-255-0068

Study Officials

• Medical Monitor

  Cumberland Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 17, 2013
• Study Start: December 1, 2014
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: June 24, 2024
• Results First Posted: June 24, 2024

Record last verified: 2024-01

Locations

US (7)