NCT04624451

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

3.6 years

First QC Date

July 9, 2020

Last Update Submit

May 7, 2024

Conditions

PeritonitisPeritonitis Bacterial

Outcome Measures

Primary Outcomes (2)

  • Clinical cure

    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

    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 Outcomes (2)

  • Treatment emergent adverse events

    14 days

  • Treatment emergent adverse events

    28 days

Interventions

DalbavancinDRUG

Dalbavancin 1500 mg intravenously x 1 dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with contraindications to dalbavancin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, California, 80045, United States

Location

Related Publications (1)

  • 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):e02089-19. doi: 10.1128/AAC.02089-19. Print 2020 Apr 21.

    PMID: 32122898BACKGROUND

MeSH Terms

Conditions

Peritonitis

Interventions

dalbavancin

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2020

First Posted

November 10, 2020

Study Start

June 1, 2020

Primary Completion

December 31, 2023

Study Completion

January 31, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)