Bacterial Infections.Phase 1NCT01946568
A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.
A Phase 1 study testing Dalbavancin in people with Bacterial Infections., run by Durata Therapeutics Inc., an affiliate of Allergan plc at 12 sites in 2 countries.
Trial summary
A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin. Read more about this study
- Who is it for?
- Ages 3 months to 11 years
- Conditions the study is for
- Bacterial Infections.
- What is being tested?
- Dalbavancin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Jun 2013to Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 3 months to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalized patients who will be receiving at least 24 hours of appropriate non-investigational intravenous anti-infective treatment for known or suspected bacterial infections with the exception of urinary tract infections.
- Written parental informed consent.
- Able to comply with the protocol for the duration of the study.
- Expected to survive throughout the study.
- Normal audiologic assessment within 3 days prior to the study drug infusion.
Who cannot join
- Investigational drug within 30 days or 5 half-lives, whichever is longest, preceding the first dose of study medication.
- History of fluctuant hearing, persistent tinnitus, balance disorder, otologic surgery or disease, tumor of the head, neck, or auditory system, head injury, Meniere's disease, autoimmune inner ear disease, perilymphatic fistula, CNS disorder resulting in hearing deficits, or significant noise exposure.
- Significant exposure to aminoglycoside antibiotics or chemotherapy currently or within a week prior to enrollment into the study or current use of loop diuretics.
- Patients continuing on vancomycin treatment or are anticipated to begin vancomycin or other glycopeptide treatment during the 7 day period after dalbavancin administration.
- Patients with any clinically significant abnormality other than that associated with their underlying disease. Aminotransferases (AST, ALT) >5 x ULN; total bilirubin and alkaline phosphatase) >2 x ULN.
- Albumin < half lower limit of normal or physical exam evidence of malnutrition.
Show all 12Show fewer
- Patients who are less than one year of age, and were born with gestational age of less than 32 weeks.
- Positive urine (or serum) pregnancy test at screening (post menarchal females only) or after admission (prior to dosing).
- Known to have hypersensitivity to glycopeptides.
- Calculated creatinine clearance <30 ml/min using the Schwartz method.
- Pregnant or nursing females.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States10 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Duke Medical Center
Durham, North Carolina, 27710
Connecicut Children's Hospital
Hartford, Connecticut, 06106
Texas Children's Hospital - Clinical Care Center
Houston, Texas, 77030
University Arkansas Medical Center
Little Rock, Arkansas, 72202
University of Louisville
Louisville, Kentucky, 40202
Columbia University
New York, New York, 10032
University of California, San Diego
San Diego, California, 92123
Pediatric Pharmacology
Toledo, Ohio, 43606
Estonia2 sites
Tallin's Children Hospital Pediatric Clinic
Tallinn, 13419
Tartu University Hospital Anesthesiology & Intensive Care
Tartu, 51015
About this study
Official title: A Phase 1, Open Label, Single Dose Study To Investigate The Pharmacokinetics, Safety and Tolerability Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years Receiving Standard Intravenous Anti-Infective Treatment For Bacterial Infections
A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
Read the detailed description
This is a open label, multi center study to investigate the pharmacokinetics, safety and tolerability of a single dose of intravenous dalbavancin in hospitalized pediatric patients with known or suspected bacterial infection. Patients will be enrolled and results will be evaluated in 3 age cohorts as follows:
Cohort 1: Patients 6 years to 11 years of age, inclusive; Cohort 2: Patients 2 years to <6 years of age; Cohort 3: Patients 3 months to <2 years of age.
All patients in each cohort will be administered a single dose of dalbavancin in addition to background anti infective treatment to be chosen by the investigator according to standard of care. Pharmacokinetic samples will be obtained at various timepoints. Dalbavancin can be administered at any time (before, during or after) the standard of care therapy.
- Conditions
- Bacterial Infections.
- Being tested
- Dalbavancin
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalbavancinDrug
Intravenous dalbavancin given at 15 mg/kg (not to exceed 1000 mg) for patients ≥5 years of age, and 25 mg/kg for patients <5 years of age.
| Study group | Role | What they receive |
|---|---|---|
| Single dose Dalbavancin | Experimental | Not described Receives: Drug: Dalbavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the pharmacokinetics in pediatric patients by measuring AUC 0-inf of dalbavancin.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
Measured: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To characterize the pharmacokinetics in pediatric patients by measuring Cmax of dalbavancin.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
Measured: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To characterize the pharmacokinetics in pediatric patients by measuring AUC0-last of dalbavancin.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
Measured: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To characterize the pharmacokinetics in pediatric patients by measuring AUC0-t of dalbavancin.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
Measured: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To characterize the pharmacokinetics in pediatric patients by measuring Tmax of dalbavancin.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
Measured: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To characterize the pharmacokinetics in pediatric patients by measuring t1/2 of dalbavancin.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
Measured: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
Secondary outcomes (3)
To evaluate the safety of a single dose of dalbavancin which will be measured by adverse event monitoring.
Measured: one year
To evaluate the safety of a single dose of dalbavancin which will be measured by clinical laboratories (hematology and serum chemistry).
Measured: one year
To evaluate the safety of a single dose of dalbavancin which will be measured by blood pressure and pulse rate.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Infections.Studies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Dunne, MD, Study director, Durata Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946568
- Sponsor's protocol ID
- DUR001-106
- Status last verified
- Jun 2015
- First submitted
- 29 Aug 2013
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Single Dose Study To Investigate The Pharmacokinetics, Safety and Tolerability Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years Receiving Standard Intravenous Anti-Infective Treatment For Bacterial Infections
- ClinicalTrials.gov ID
- NCT01946568
- Acronym / sponsor ID
- DUR001-106
- Conditions
- Bacterial Infections.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plcIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
Detailed description
This is a open label, multi center study to investigate the pharmacokinetics, safety and tolerability of a single dose of intravenous dalbavancin in hospitalized pediatric patients with known or suspected bacterial infection. Patients will be enrolled and results will be evaluated in 3 age cohorts as follows:
Cohort 1: Patients 6 years to 11 years of age, inclusive; Cohort 2: Patients 2 years to <6 years of age; Cohort 3: Patients 3 months to <2 years of age.
All patients in each cohort will be administered a single dose of dalbavancin in addition to background anti infective treatment to be chosen by the investigator according to standard of care. Pharmacokinetic samples will be obtained at various timepoints. Dalbavancin can be administered at any time (before, during or after) the standard of care therapy.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single dose Dalbavancin | Experimental | Drug: Dalbavancin |
Who may qualify
- Ages
- 3 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Hospitalized patients who will be receiving at least 24 hours of appropriate non-investigational intravenous anti-infective treatment for known or suspected bacterial infections with the exception of urinary tract infections.
- Written parental informed consent.
- Able to comply with the protocol for the duration of the study.
- Expected to survive throughout the study.
- Normal audiologic assessment within 3 days prior to the study drug infusion.
Key exclusion criteria (12 listed)
- Investigational drug within 30 days or 5 half-lives, whichever is longest, preceding the first dose of study medication.
- History of fluctuant hearing, persistent tinnitus, balance disorder, otologic surgery or disease, tumor of the head, neck, or auditory system, head injury, Meniere's disease, autoimmune inner ear disease, perilymphatic fistula, CNS disorder resulting in hearing deficits, or significant noise exposure.
- Significant exposure to aminoglycoside antibiotics or chemotherapy currently or within a week prior to enrollment into the study or current use of loop diuretics.
- Patients continuing on vancomycin treatment or are anticipated to begin vancomycin or other glycopeptide treatment during the 7 day period after dalbavancin administration.
- Patients with any clinically significant abnormality other than that associated with their underlying disease. Aminotransferases (AST, ALT) >5 x ULN; total bilirubin and alkaline phosphatase) >2 x ULN.
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 |
|---|---|---|
| DalbavancinIntravenous dalbavancin given at 15 mg/kg (not to exceed 1000 mg) for patients ≥5 years of age, and 25 mg/kg for patients <5 years of age. | Drug | Single dose Dalbavancin |
Primary outcome
To characterize the pharmacokinetics in pediatric patients by measuring AUC 0-inf of dalbavancin.
Time frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
To characterize the pharmacokinetics in pediatric patients by measuring Cmax of dalbavancin.
Time frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
To characterize the pharmacokinetics in pediatric patients by measuring AUC0-last of dalbavancin.
Time frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
To characterize the pharmacokinetics in pediatric patients by measuring AUC0-t of dalbavancin.
Time frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
To characterize the pharmacokinetics in pediatric patients by measuring Tmax of dalbavancin.
Time frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
To characterize the pharmacokinetics in pediatric patients by measuring t1/2 of dalbavancin.
Time frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
3 secondary outcomes
To evaluate the safety of a single dose of dalbavancin which will be measured by adverse event monitoring.
Time frame: one year
To evaluate the safety of a single dose of dalbavancin which will be measured by clinical laboratories (hematology and serum chemistry).
Time frame: one year
To evaluate the safety of a single dose of dalbavancin which will be measured by blood pressure and pulse rate.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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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.
Michael Dunne, MD study director
Durata Therapeutics
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dalbavancin in people with Bacterial Infections., run by Durata Therapeutics Inc., an affiliate of Allergan plc at 12 sites in 2 countries.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Estonia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To characterize the pharmacokinetics in pediatric patients by measuring AUC 0-inf of dalbavancin. (time frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2015.