Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02940730 |
| Other study ID # |
16-1355 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2017 |
| Est. completion date |
June 18, 2018 |
Study information
| Verified date |
February 2021 |
| Source |
University of Colorado, Denver |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
This study is an open label, cross-over study, evaluating the plasma and peritoneal fluid
pharmacokinetics (PK) of dalbavancin after either intravenous or intraperitoneal
administration. In the first part of the study, ten patients will be administered dalbavancin
on study day 0. Pharmacokinetic analysis will be conducted on days 0, 7, and 14. In the
second part of the study, the same 10 patients will cross-over and then be administered
dalbavancin on study day 0. Pharmacokinetic analysis will be conducted on days 0, 7, and 14.
Sample Size:
Ten (n=10) patients will be evaluated in this pharmacokinetic evaluation. Since this is a
descriptive pharmacokinetic study a sample size calculation was not performed
Plasma and peritoneal fluid sampling:
Dalbavancin will be administered on study day 0. On the intravenous administration day
dalbavancin will be administered as a 30-minute intravenous (IV) infusion. On the
intraperitoneal administration day, dalbavancin will be administered in the peritoneal
dialysis fluid with a 6 hour dwell time. On day 0, patients will undergo plasma and
peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at
time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange. Patients
will be given a specimen collection cup and asked to collect ~30 ml of peritoneal dialysate
following scheduled nocturnal dwell approximately 24 hours following the administration of
dalbavancin administration. Patients will report for a single PK measurement on study days 7
and 14. (18 total plasma and 18 total peritoneal fluid samples per patient). Blood samples
will be drawn from a peripherally inserted intravenous catheter. Peritoneal fluid samples
will be drawn from the already placed peritoneal dialysis catheter. Blood samples will be
immediately centrifuged at 3000g and plasma and peritoneal fluid samples will be stored at
-80°C until analysis.
Description, Risks and Justification of Procedures and Data Collection Tools:
Visit 1 and 4: (~8 hours): On visits 1 and 4 the patients will undergo intensive PK sampling.
Subjects will be admitted to the Clinical and Translational Research Center (CTRC) in the
morning and a "saline-lock" will be placed. A pre-dose sample and safety labs (comprehensive
metabolic panel and urine pregnancy test for women of childbearing potential) will be
obtained. The dalbavancin 1500 mg will either be administered intravenously (Visit 1) or into
the intraperitoneal space (Visit 4) using the patient's existing peritoneal dialysis catheter
with the patients currently prescribed dialysate. Following the blood and peritoneal fluid
collection at the second dialysis volume exchange, the subjects will be discharged and asked
to return at a scheduled time on day 7. Patients will also be given a specimen collection up
with instructions to collect approximately 30 ml of peritoneal dialysate following their
evening nocturnal dwell. The collected dialysate will be returned to the investigators.
Visit 2, 3, 5, and 6: (~60 minutes): A "saline-lock" will be placed and blood and peritoneal
fluid sample will be collected at each of these visits. All blood and peritoneal fluid draws
will be completed at the CTRC. The patient will be discharged and follow up visits will be
scheduled for day 14 or next intensive PK sampling visit.
Washout: During the washout portion of this study the patients will not be asked to come in
for any visits. This time-frame is to ensure that all of the medication (dalbavancin) has
left the patients' system before administering another dose of the medication.
Laboratory tests: The laboratory tests to be performed as part of this study include
pregnancy testing to confirm eligibility and comprehensive metabolic panels to determine
eligibility and evaluate safety.
Pharmacokinetic Assessments: 4 mL of blood will be collected in a purple top
(Ethylenediaminetetraacetic acid) tube and 4 mL of peritoneal fluid in a urine collection cup
at pre-dose, and 1, 2, 3, 4, 6, dialysis volume exchange 1, 8, dialysis volume exchange 2
post dose for quantification of dalbavancin. Blood and peritoneal fluid will be placed in an
ice bath to chill until centrifuged. Plasma will be harvested within 30 minutes of each blood
sample and will be stored at -80ºC until assaying.
