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TerminatedNCT04624451Updated May 9, 2024

Evaluation of Intravenous Dalbavancin for Peritonitis

An observational study in Peritonitis and Peritonitis Bacterial, sponsored by University of Colorado, Denver. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by University of Colorado, Denver · Observational

Why this study was terminated
Slow recruitment
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Peritonitis
  • Peritonitis Bacterial

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03

In context

Peritonitis

189 studies on the registry are indexed under Peritonitis; 26 are open to participants now.

This study's enrollment of 2 is below the median of 125 across 60 observational studies indexed under Peritonitis.

Browse Peritonitis studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 318 are open to participants now.

Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Patients with contraindications to dalbavancin therapy

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2 participants (actual)
Patient registry
No

Interventions

  • Dalbavancin 1500 mg intravenously x 1 dose

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 14 days

  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

    Time frame: 28 days

Secondary outcomes

  1. Treatment emergent adverse events

    Occurrence of any adverse events

    Time frame: 14 days

  2. Treatment emergent adverse events

    Occurrence of any adverse events

    Time frame: 28 days

07

Study locations

1 site
  • University of Colorado Hospital
    Aurora, California 80045, United States
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References and documents

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):e02089-19. doi: 10.1128/AAC.02089-19. Print 2020 Apr 21. PubMed 32122898 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2020 to primary completion in Dec 2023, 42 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2020
First posted
Nov 10, 2020
StartActual
Jun 1, 2020
Primary completionActual
Dec 31, 2023
CompletionActual
Jan 31, 2024
Last update
May 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04624451
Responsible party
Sponsor
First posted
Nov 10, 2020
Start date
Jun 1, 2020
Primary completion
Dec 31, 2023
Completion
Jan 31, 2024
Last update
May 9, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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