Evaluation of Intravenous Dalbavancin for Peritonitis

February 22, 2022 updated by: University of Colorado, Denver

Evaluation of Intravenous Dalbavancin for Treatment of Peritonitis in Peritoneal Dialysis Patients

This study evaluates the use of Dalbavancin 1500 mg IV x 1 dose for treating patients with gram positive peritonitis in patients requiring peritoneal dialysis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Aurora, California, United States, 80045
        • Recruiting
        • University of Colorado Hospital
        • Contact:
        • Principal Investigator:
          • Ty Kiser, PharmD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients currently receiving peritoneal dialysis that are found to have bacterial peritonitis

Description

Inclusion Criteria:

Patients > 18 years of age actively receiving peritoneal dialysis diagnosed with a gram + peritonitis determined to be a good candidate for dalbavancin treatment by the attending nephrology attending.

Exclusion Criteria:

Patients with contraindications to dalbavancin therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical cure
Time Frame: 14 days
resolution of signs and symptoms (e.g. abdominal pain), bacterial eradication, reduction in clinical markers (e.g. peritoneal fluid findings, CRP, etc), and return of peritoneal dialysis functionality
14 days
Clinical cure
Time Frame: 28 days
resolution of signs and symptoms (e.g. abdominal pain), bacterial eradication, reduction in clinical markers (e.g. peritoneal fluid findings, CRP, etc), and return of peritoneal dialysis functionality
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment emergent adverse events
Time Frame: 14 days
Occurrence of any adverse events
14 days
Treatment emergent adverse events
Time Frame: 28 days
Occurrence of any adverse events
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

June 30, 2024

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (ACTUAL)

November 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-1731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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