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Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected Bacterial Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02688790
Recruitment Status : Terminated
First Posted : February 23, 2016
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief 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.

Condition or disease Intervention/treatment Phase
Bacterial Infections Drug: Dalbavancin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of a Single-Dose of Dalbavancin in Preterm Neonates to Infants Ages 3 Months With Suspected or Confirmed Bacterial Infection
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : April 3, 2019
Actual Study Completion Date : April 3, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dalbavancin

Arm Intervention/treatment
Experimental: Cohort 1
One dose of intravenous dalbavancin infusion 22.5 mg/kg in young infants aged greater than 28 days to 3 months
Drug: Dalbavancin
Other Name: Dalvance®

Experimental: Cohort 2
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
Drug: Dalbavancin
Other Name: Dalvance®

Experimental: Cohort 3
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
Drug: Dalbavancin
Other Name: Dalvance®




Primary Outcome Measures :
  1. Plasma concentration of dalbavancin [ Time Frame: Day 1, Day 2, Day 5-9 and Day 24-32 ]
  2. Number of patients experiencing a treatment emergent adverse event [ Time Frame: Baseline (Day 1) up to Day 35 ]

Secondary Outcome Measures :
  1. Maximum plasma drug concentration (Cmax) [ Time Frame: Day 1, Day 2, Day 5-9 and Day 24-32 ]
  2. Area under the plasma concentration versus time curve (AUC) [ Time Frame: Day 1, Day 2, Day 5-9 and Day 24-32 ]
  3. Apparent total body clearance (CL) of drug from plasma [ Time Frame: Day 1, Day 2, Day 5-9 and Day 24-32 ]
  4. Apparent volume of distribution volume of distribution (V) [ Time Frame: Day 1, Day 2, Day 5-9 and Day 24-32 ]
  5. Terminal elimination half-life (T1/2). [ Time Frame: Day 1, Day 2, Day 5-9 and Day 24-32 ]


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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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,

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688790


Locations
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United States, California
Mary Birch Hospital for Women and Newborns
San Diego, California, United States, 92123
University of California, San Diego
San Diego, California, United States, 92123
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Missouri
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64108
United States, North Carolina
Duke Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Todd Riccobene Allergan, plc
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02688790    
Obsolete Identifiers: NCT03617042
Other Study ID Numbers: DAL-PK-02
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allergan:
Dalbavancin
DALVANCE®
Suspected or Confirmed Bacterial Infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Dalbavancin
Anti-Bacterial Agents
Anti-Infective Agents