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
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Peritonitis
• Peritonitis Bacterial

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