Phase 4
N=10
Evaluation of Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients
Infectious Peritonitis
Bottom Line
View on ClinicalTrials.gov: NCT02940730 ↗Enrolled (actual)
10
Serious AEs
23.1%
Results posted
Mar 2021
Primary outcome: Primary: Determine Dalbavancin Plasma Area Under the Curve in Peritoneal Dialysis Patients After Intravenous and Intraperitoneal Administration — 40573.2; 13532.3 mg*h/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dalbavancin via Intravenous Administration (Drug); Dalbavancin via Intraperitoneal Administration (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine Dalbavancin Plasma Area Under the Curve in Peritoneal Dialysis Patients After Intravenous and Intraperitoneal Administration |
40573.2; 13532.3 | — |
| PRIMARY Determine Dalbavancin Peritoneal Fluid Area Under the Curve in Peritoneal Dialysis Patients After Intravenous and Intraperitoneal Administration |
2125; 69654.3 | — |
| SECONDARY Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0 |
0; 3 | — |
| SECONDARY Determine Dalbavancin Plasma Clearance in Peritoneal Dialysis Patients After Intravenous and Intraperitoneal Administration |
0.0298; 0.059 | — |
| SECONDARY Determine Dalbavancin Peritoneal Fluid Clearance in Peritoneal Dialysis Patients After Intravenous and Intraperitoneal Administration |
0.586; 0.034 | — |
Summary
This study will evaluate the pharmacokinetic properties of dalbavancin when administered as an intravenous infusion and instilled into the peritoneal space in patients who are undergoing peritoneal dialysis. The patients will receive intravenous dalbavancin followed by intensive plasma and peritoneal dialyses fluid sampling. Following a washout phase, the patients will then receive dalbavancin instilled into their peritoneal space followed by the same intensive plasma and peritoneal dialyses fluid sampling.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 to ≤89 years of age
- Actively receiving chronic peritoneal dialysis
- Ability and willingness to provide written informed consent
Exclusion Criteria
- Patients currently receiving antimicrobial therapy or have received antibiotic therapy within 14 days prior to study
- Patients with known hypersensitivity reactions to dalbavancin or other glycopeptides
- Prisoners
- Pregnant or breastfeeding women
- Decisionally challenged patients
Data sourced from ClinicalTrials.gov (NCT02940730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.