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

Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Age Range:Any
Start Date:April 1, 2016
End Date:October 31, 2019
Contact:Clinical Trials Registry Team

Use our guide to learn which trials are right for you!

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.

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
We found this trial at
San Diego, California 92093
San Diego, CA
Click here to add this to my saved trials
282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
Hartford, CT
Click here to add this to my saved trials
Chicago, IL
Click here to add this to my saved trials
Durham, North Carolina 27708
Durham, NC
Click here to add this to my saved trials
Kansas City, Kansas 64108
Kansas City, KS
Click here to add this to my saved trials
Little Rock, Arkansas 72205
Little Rock, AR
Click here to add this to my saved trials
500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
Louisville, KY
Click here to add this to my saved trials
San Diego, California 92123
San Diego, CA
Click here to add this to my saved trials
Shreveport, Louisiana 71130
Shreveport, LA
Click here to add this to my saved trials