Bacterial InfectionsPhase 1NCT02688790
Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected Bacterial Infection
A Phase 1 study testing Dalbavancin in people with Bacterial Infections, run by AbbVie at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability of a single dalbavancin IV infusion. Read more about this study
- Who is it for?
- Ages Up to 28 days
- 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
- 8 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Apr 2016to 3 Apr 2019
- 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalized male and female patients who are preterm neonates (gestational age
- ≥32 to <37 weeks, aged ≤28 days), term neonates (gestational age ≥37 weeks, aged ≤28 days) or young infants (aged 28 days to 3 months inclusive) who will be receiving at least 24 hours of appropriate non-investigational intravenous antiinfective treatment other than glycopeptide antibiotics for known or suspected bacterial infections. Patients with urinary tract infections due to Gram-positive organisms may be enrolled
- Each patient's parent(s)/legal guardian(s) must be willing and able to provide a signed and dated written informed consent document indicating that they have been informed of all pertinent aspects of the trial
- Each patient's parent(s)/legal guardian(s) must be willing and able, if patient is discharged from the hospital, to return the patient to the hospital or a designated clinic for scheduled visits, or allow a nurse to come to the patient's home for laboratory tests, PK and other out-patient procedures as required by the protocol
- Patients must be expected to survive with appropriate antibiotic therapy and appropriate supportive care throughout the study
- Sufficient intravenous access (peripheral or central) to receive Investigational Product (IP)
- Patients must have an audiologic assessment within 7 days prior to the investigational product infusion consisting of ear specific hearing testing utilizing distortion product evoked otoacoustic emissions,
Who cannot join
- 1. Treatment with an investigational drug within 30 days preceding the dose of IP
- Patients who are currently receiving intravenous vancomycin or other glycopeptide antibiotics. Dalbavancin may be administered 8 hours after the last dose of vancomycin. Vancomycin or other glycopeptide antibiotics should not be given during the 7 day period following administration of dalbavancin. If intravenous vancomycin or other glycopeptide use is unavoidable during the 7 day period following administration of dalbavancin, this should be documented as a concomitant medication
- Have aspartate aminotransferase (AST), alanine transaminase (ALT) or total bilirubin level > 3 times upper limit of normal (neonates with elevated total bilirubin could participate if conjugated bilirubin was normal)
- Albumin < half lower limit of normal
- Have received a blood or blood component (eg, red blood cells, fresh frozen plasma, platelets) transfusion during the 24-hour period before dosing
- Have any condition (eg. Septic shock, burns, cystic fibrosis, acute hemodynamic instability including those conditions requiring pressor support) that would make the patient, in the opinion of the Investigator, unsuitable for the study (eg, would place the patient at risk, compromise the quality of the data; or interfere with the absorption, distribution, metabolism or excretion of dalbavancin)
Show all 9Show fewer
- Patients known to have hypersensitivity to glycopeptides
- Moderate or severe renal impairment defined as serum creatinine ≥2 times the upper limit of normal (× ULN) for age OR urine output <0.5 mL/kg/h (measured over at least 8 hours) OR requirement for dialysis)
- Other severe acute or chronic medical 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Duke Medical Center
Durham, North Carolina, 27710
Children's Mercy Kansas City
Kansas City, Missouri, 64108
University of Louisville
Louisville, Kentucky, 40202
Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
University of California, San Diego
San Diego, California, 92123
About this study
Official title: Pharmacokinetics of a Single-Dose of Dalbavancin in Preterm Neonates to Infants Ages 3 Months With Suspected or Confirmed Bacterial Infection
The purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability of a single dalbavancin IV infusion.
- Conditions
- Bacterial Infections
- Being tested
- Dalbavancin
- Keywords
- Dalbavancin, DALVANCE®, Suspected or Confirmed Bacterial Infection
- 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
Also called Dalvance®
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | One dose of intravenous dalbavancin infusion 22.5 mg/kg in young infants aged greater than 28 days to 3 months Receives: Drug: Dalbavancin |
| Cohort 2 | Experimental | One dose of intravenous dalbavancin infusion 22.5 mg/kg in term neonates (defined as gestational age at or greater than 37 weeks) aged up to 28 days Receives: Drug: Dalbavancin |
| Cohort 3 | Experimental | One dose of intravenous dalbavancin infusion 22.5 mg/kg in preterm neonates (defined as gestational age of 32 weeks, up to 37 weeks) aged no more than 28 days Receives: Drug: Dalbavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of dalbavancin
Measured: Day 1, Day 2, Day 5-9 and Day 24-32
Number of patients experiencing a treatment emergent adverse event
Measured: Baseline (Day 1) up to Day 35
Secondary outcomes (5)
Maximum plasma drug concentration (Cmax)
Measured: Day 1, Day 2, Day 5-9 and Day 24-32
Area under the plasma concentration versus time curve (AUC)
Measured: Day 1, Day 2, Day 5-9 and Day 24-32
Apparent total body clearance (CL) of drug from plasma
Measured: Day 1, Day 2, Day 5-9 and Day 24-32
Apparent volume of distribution volume of distribution (V)
Measured: Day 1, Day 2, Day 5-9 and Day 24-32
Terminal elimination half-life (T1/2).
Measured: Day 1, Day 2, Day 5-9 and Day 24-32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start1 Apr 2016
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Riccobene, Study director, Allergan, plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688790
- Sponsor's protocol ID
- DAL-PK-02
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2016
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of a Single-Dose of Dalbavancin in Preterm Neonates to Infants Ages 3 Months With Suspected or Confirmed Bacterial Infection
- ClinicalTrials.gov ID
- NCT02688790
- Acronym / sponsor ID
- DAL-PK-02
- Conditions
- Bacterial Infections
- Keywords
- Dalbavancin, DALVANCE®, Suspected or Confirmed Bacterial Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 23 Feb 2016 (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.
The purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability of a single dalbavancin IV infusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: DalbavancinOne dose of intravenous dalbavancin infusion 22.5 mg/kg in young infants aged greater than 28 days to 3 months |
| Cohort 2 | Experimental | Drug: DalbavancinOne dose of intravenous dalbavancin infusion 22.5 mg/kg in term neonates (defined as gestational age at or greater than 37 weeks) aged up to 28 days |
| Cohort 3 | Experimental | Drug: DalbavancinOne dose of intravenous dalbavancin infusion 22.5 mg/kg in preterm neonates (defined as gestational age of 32 weeks, up to 37 weeks) aged no more than 28 days |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Hospitalized male and female patients who are preterm neonates (gestational age
- ≥32 to <37 weeks, aged ≤28 days), term neonates (gestational age ≥37 weeks, aged ≤28 days) or young infants (aged 28 days to 3 months inclusive) who will be receiving at least 24 hours of appropriate non-investigational intravenous antiinfective treatment other than glycopeptide antibiotics for known or suspected bacterial infections. Patients with urinary tract infections due to Gram-positive organisms may be enrolled
- Each patient's parent(s)/legal guardian(s) must be willing and able to provide a signed and dated written informed consent document indicating that they have been informed of all pertinent aspects of the trial
- Each patient's parent(s)/legal guardian(s) must be willing and able, if patient is discharged from the hospital, to return the patient to the hospital or a designated clinic for scheduled visits, or allow a nurse to come to the patient's home for laboratory tests, PK and other out-patient procedures as required by the protocol
- Patients must be expected to survive with appropriate antibiotic therapy and appropriate supportive care throughout the study
Key exclusion criteria (9 listed)
- 1. Treatment with an investigational drug within 30 days preceding the dose of IP
- Patients who are currently receiving intravenous vancomycin or other glycopeptide antibiotics. Dalbavancin may be administered 8 hours after the last dose of vancomycin. Vancomycin or other glycopeptide antibiotics should not be given during the 7 day period following administration of dalbavancin. If intravenous vancomycin or other glycopeptide use is unavoidable during the 7 day period following administration of dalbavancin, this should be documented as a concomitant medication
- Have aspartate aminotransferase (AST), alanine transaminase (ALT) or total bilirubin level > 3 times upper limit of normal (neonates with elevated total bilirubin could participate if conjugated bilirubin was normal)
- Albumin < half lower limit of normal
- Have received a blood or blood component (eg, red blood cells, fresh frozen plasma, platelets) transfusion during the 24-hour period before dosing
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 |
|---|---|---|
| DalbavancinAlso: Dalvance® | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Plasma concentration of dalbavancin
Time frame: Day 1, Day 2, Day 5-9 and Day 24-32
Number of patients experiencing a treatment emergent adverse event
Time frame: Baseline (Day 1) up to Day 35
5 secondary outcomes
Maximum plasma drug concentration (Cmax)
Time frame: Day 1, Day 2, Day 5-9 and Day 24-32
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 1, Day 2, Day 5-9 and Day 24-32
Apparent total body clearance (CL) of drug from plasma
Time frame: Day 1, Day 2, Day 5-9 and Day 24-32
Apparent volume of distribution volume of distribution (V)
Time frame: Day 1, Day 2, Day 5-9 and Day 24-32
Terminal elimination half-life (T1/2).
Time frame: Day 1, Day 2, Day 5-9 and Day 24-32
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
Related trials for Bacterial Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
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.
Todd Riccobene study director
Allergan, plc
5 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 Dalbavancin in people with Bacterial Infections, run by AbbVie at 5 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 7 inclusion and 9 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 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study was stopped early. Results are not available in the source record.
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?
Plasma concentration of dalbavancin (time frame: Day 1, Day 2, Day 5-9 and Day 24-32). The study lists 2 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 29 Mar 2022.