Evaluation of Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients

• Status: Completed
• Trial end date: 2018-06-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Dalbavancin; Teicoplanin

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