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Evaluation of Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients

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: NCT02940730
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This study will evaluate the pharmacokinetic properties of dalbavancin when administered as an intravenous infusion and instilled into the peritoneal space in patients who are undergoing peritoneal dialysis. The patients will receive intravenous dalbavancin followed by intensive plasma and peritoneal dialyses fluid sampling. Following a washout phase, the patients will then receive dalbavancin instilled into their peritoneal space followed by the same intensive plasma and peritoneal dialyses fluid sampling.

Condition or disease Intervention/treatment Phase
Infectious Peritonitis Drug: Dalbavancin via Intravenous Administration Drug: Dalbavancin via Intraperitoneal Administration Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : June 18, 2018
Actual Study Completion Date : June 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Dalbavancin

Arm Intervention/treatment
Active Comparator: Dalbavancin via IV
Dalbavancin will be administered via intravenous administration. Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.
Drug: Dalbavancin via Intravenous Administration
Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.

Active Comparator: Dalbavancin via IP
Dalbavancin will be administered as an intraperitoneal administration. Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.
Drug: Dalbavancin via Intraperitoneal Administration
Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.




Primary Outcome Measures :
  1. Determine dalbavancin plasma area under the curve in peritoneal dialysis patients after intravenous and intraperitoneal administration [ Time Frame: 14 days ]
    14 day plasma concentrations

  2. Determine dalbavancin peritoneal fluid area under the curve in peritoneal dialysis patients after intravenous and intraperitoneal administration [ Time Frame: 14 days ]
    14 day peritoneal fluid concentrations


Secondary Outcome Measures :
  1. Number of patients with grade 3 through grade 5 adverse events that are related to study drug, graded according to NCI CTCAE version 3.0 [ Time Frame: 14 days ]
    Adverse reactions

  2. Determine dalbavancin plasma clearance in peritoneal dialysis patients after intravenous and intraperitoneal administration [ Time Frame: 14 days ]
    Dalbavancin plasma clearance

  3. Determine dalbavancin peritoneal fluid clearance in peritoneal dialysis patients after intravenous and intraperitoneal administration [ Time Frame: 14 days ]
    Dalbavancin peritoneal fluid clearance



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥18 to ≤89 years of age
  • Actively receiving chronic peritoneal dialysis
  • Ability and willingness to provide written informed consent

Exclusion Criteria:

  • Patients currently receiving antimicrobial therapy or have received antibiotic therapy within 14 days prior to study
  • Patients with known hypersensitivity reactions to dalbavancin or other glycopeptides
  • Prisoners
  • Pregnant or breastfeeding women
  • Decisionally challenged patients

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): NCT02940730


Locations
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United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Ty H Kiser, PharmD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02940730    
Other Study ID Numbers: 16-1355
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peritonitis
Infection
Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases
Dalbavancin
Teicoplanin
Anti-Bacterial Agents
Anti-Infective Agents