Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03617042
Other study ID # DAL-PK-02
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 1, 2016
Est. completion date October 31, 2019

Study information

Verified date August 2018
Source Allergan
Contact Clinical Trials Registry Team
Phone 1-800-347-4500
Email IR-CTRegistration@allergan.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Other known NCT identifiers
  • NCT02688790

Recruitment information / eligibility

Status Recruiting
Enrollment 22
Est. completion date October 31, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Days
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dalbavancin


Locations

Country Name City State
United States Ann & Robert H. Laurie Children's Hopsital Chicago Illinois
United States Duke Medical Center Durham North Carolina
United States Connecticut Children's Medical Center Hartford Connecticut
United States Children's Mercy Kansas City Kansas City Kansas
United States University of Arkansas Medical Center Little Rock Arkansas
United States University of Louisville Louisville Kentucky
United States Mary Birch Hospital for Women and Newborns San Diego California
United States University of California, San Diego San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma concentration of dalbavancin Day 1, Day 2, Day 5-9 and Day 24-32
Primary Number of patients experiencing a treatment emergent adverse event Baseline (Day 1) up to Day 35
Secondary Maximum plasma drug concentration (Cmax) Day 1, Day 2, Day 5-9 and Day 24-32
Secondary Area under the plasma concentration versus time curve (AUC) Day 1, Day 2, Day 5-9 and Day 24-32
Secondary Apparent total body clearance (CL) of drug from plasma Day 1, Day 2, Day 5-9 and Day 24-32
Secondary Apparent volume of distribution volume of distribution (V) Day 1, Day 2, Day 5-9 and Day 24-32
Secondary Terminal elimination half-life (T1/2). Day 1, Day 2, Day 5-9 and Day 24-32
See also
  Status Clinical Trial Phase
Completed NCT03726216 - Xydalba Utilization Registry in France
Completed NCT03605498 - OR PathTrac (Tracking Intra-operative Bacterial Transmission)
Withdrawn NCT05269121 - Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections Phase 1/Phase 2
Completed NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli N/A
Recruiting NCT02074865 - Children's Antibiotic Resistant Infections in Low Income Countries N/A
Completed NCT01689207 - To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) Phase 1
Completed NCT01932034 - Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Computer Software N/A
Completed NCT01412801 - Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings Phase 2
Not yet recruiting NCT01159470 - The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children N/A
Completed NCT00983255 - Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA) Phase 1
Completed NCT00799591 - French Study In ICU Patients Treated With Tigecycline N/A
Completed NCT00678106 - Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections Phase 1
Completed NCT00478855 - Tazocin Intervention Study Phase 4
Completed NCT01074775 - Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection N/A
Terminated NCT00431028 - Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery Phase 1/Phase 2
Not yet recruiting NCT03634904 - Serum Ceftazidime Concentrations in Hemodialysis Patients N/A
Recruiting NCT05684705 - Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100 Phase 1
Recruiting NCT03858387 - PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients
Enrolling by invitation NCT04764058 - Efficacy and Safety of Colistin Based Antibiotic Therapy Phase 1/Phase 2
Recruiting NCT06319235 - Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG® Phase 1/Phase 2