Evaluation of Intravenous Dalbavancin for Peritonitis

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT04624451

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Peritonitis Peritonitis Bacterial	Drug: Dalbavancin

Study Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Outcome Measures

Primary Outcome Measures

Clinical cure [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
Clinical cure [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

Secondary Outcome Measures

Treatment emergent adverse events [14 days]
Occurrence of any adverse events
Treatment emergent adverse events [28 days]
Occurrence of any adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Hospital	Aurora	California	United States	80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Van Matre ET, Teitelbaum I, Kiser TH. Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients. Antimicrob Agents Chemother. 2020 Apr 21;64(5). pii: e02089-19. doi: 10.1128/AAC.02089-19. Print 2020 Apr 21.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT04624451

Other Study ID Numbers:

19-1731

First Posted:

Nov 10, 2020

Last Update Posted:

Feb 24, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Peritonitis

Dalbavancin

Study Results

No Results Posted as of Feb 24, 2022