Gram-Positive Bacterial InfectionsPhase 1NCT02013141
Telavancin Pediatric PK Study (Ages >12 Months to 17 Years)
A Phase 1 study testing Telavancin in people with Gram-Positive Bacterial Infections, run by Cumberland Pharmaceuticals at 7 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 months to 17 years
- Conditions the study is for
- Gram-Positive Bacterial Infections
- What is being tested?
- Telavancin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2014to Mar 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Children's Mercy Hospital
Kansas City, Missouri, 64108
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Children's Hospital of Orange County
Orange, California, 92868
Rady Children's Hospital San Diego
San Diego, California, 92123
Toledo Children's Hospital
Toledo, Ohio, 43606
About this study
Official title: An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 12 Months to 17 Years
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
Read the detailed description
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 in male or female infants, children, and adolescents (> 12 months to 17 years, inclusive) who require systemic antibiotic therapy for the treatment or prevention of a known or suspected bacterial infection.
Blood samples for PK assessment will be taken as follows: 1.0 hour (±5 min), 1.5 hours (±5 min), 2 hours (±5 min), 6 hours (±30 min), 12 hours (±30 min) and 24 hours (±30 minutes) after the beginning of the infusion. The timing of PK sampling may be optimized after the completion of the older age groups (Cohorts 1-3) to assure that the minimum numbers of samples are collected in the youngest age group > 12months to < 24 months. Plasma exposures that will be compared to adult exposures are the primary assessment for this study.
Subject safety will be monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, concomitant medication usage, and adverse event reporting.
- Conditions
- Gram-Positive Bacterial Infections
- Being tested
- Telavancin
- Keywords
- Gram positive bacteria, Telavancin, VIBATIV, Pediatric, Pharmacokinetics
- Medical subject headings
- Gram-Positive Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelavancinDrug
Also called VIBATIV, TD-6424
| Study group | Role | What they receive |
|---|---|---|
| Telavancin | Experimental | Telavancin 10 mg/kg IV administered over approximately 60 minutes one time. Receives: Drug: Telavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours
Secondary outcomes (2)
Safety- Number of Treatment-emergent Adverse Events.
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
Measured: Day 0 (screening) through follow-up on Day 8 (+/- 1 day)
Safety- Number of Subjects With Treatment-emergent Adverse Events
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
Measured: Day 0 (screening) through follow-up on Day 8 (+/- 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startDec 2014
- Primary completionMar 2021
- Study completionMar 2021
Why it stopped: FDA waived the pediatric study requirement for this application
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gram-Positive Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013141
- Sponsor's protocol ID
- 0101
- Status last verified
- Jan 2024
- First submitted
- 11 Dec 2013
- Last updated
- 24 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 37815398
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 12 Months to 17 Years
- ClinicalTrials.gov ID
- NCT02013141
- Acronym / sponsor ID
- 0101
- Conditions
- Gram-Positive Bacterial Infections
- Keywords
- Gram positive bacteria, Telavancin, VIBATIV, Pediatric, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA waived the pediatric study requirement for this application
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Posted 24 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 in male or female infants, children, and adolescents (> 12 months to 17 years, inclusive) who require systemic antibiotic therapy for the treatment or prevention of a known or suspected bacterial infection.
Blood samples for PK assessment will be taken as follows: 1.0 hour (±5 min), 1.5 hours (±5 min), 2 hours (±5 min), 6 hours (±30 min), 12 hours (±30 min) and 24 hours (±30 minutes) after the beginning of the infusion. The timing of PK sampling may be optimized after the completion of the older age groups (Cohorts 1-3) to assure that the minimum numbers of samples are collected in the youngest age group > 12months to < 24 months. Plasma exposures that will be compared to adult exposures are the primary assessment for this study.
Subject safety will be monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, concomitant medication usage, and adverse event reporting.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telavancin | Experimental | Drug: TelavancinTelavancin 10 mg/kg IV administered over approximately 60 minutes one time. |
Who may qualify
- Ages
- 12 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelavancinAlso: VIBATIV, TD-6424 | Drug | Telavancin |
Primary outcome
Pharmacokinetics- Area Under the Curve Extrapolated to Infinity for the Plasma Concentration Versus Time Curves for Telavancin
Time frame: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours
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.
Pharmacokinetics- Maximum Plasma Concentration of Telavancin
Time frame: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours
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.
Pharmacokinetics- Time to Maximum Plasma Telavancin Concentration
Time frame: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours
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.
Pharmacokinetics- Terminal Elimination Half-life for Plasma Telavancin
Time frame: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours
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.
Pharmacokinetics- Area Under the Curve From Time Zero to the Last Sample for the Telavancin Plasma Concentration Versus Time Curve
Time frame: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours
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.
2 secondary outcomes
Safety- Number of Treatment-emergent Adverse Events.
Time frame: Day 0 (screening) through follow-up on Day 8 (+/- 1 day)
Safety- Number of Subjects With Treatment-emergent Adverse Events
Time frame: Day 0 (screening) through follow-up on Day 8 (+/- 1 day)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37815398Bradley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Cumberland Pharmaceuticals
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telavancin in people with Gram-Positive Bacterial Infections, run by Cumberland Pharmaceuticals at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics- Area Under the Curve Extrapolated to Infinity for the Plasma Concentration Versus Time Curves for Telavancin (time frame: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02013141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.