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NCT04624451 Clinical Trial

Evaluation of Intravenous Dalbavancin for Peritonitis

Peritonitis Clinical Trial

Official title:
Evaluation of Intravenous Dalbavancin for Treatment of Peritonitis in Peritoneal Dialysis Patients

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04624451
Other study ID # 19-1731
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date January 31, 2024

Study information
Verified date May 2024
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date January 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dalbavancin
Dalbavancin 1500 mg intravenously x 1 dose

Locations
Country Name City State
United States University of Colorado Hospital Aurora California

Sponsors (1)
Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Treatment emergent adverse events Occurrence of any adverse events 14 days
Secondary Treatment emergent adverse events Occurrence of any adverse events 28 days
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