to investigate whether the bioavailability of posaconazole in graft-versus-host-disease (GVHD) patients, adversely affected by the coadministration of proton pump inhibitors (PPIs), can be restored by an acidic beverage
ID
Source
Brief title
Condition
- Other condition
- Fungal infectious disorders
Synonym
Health condition
graft versus host ziekte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
difference in the bioavailability of posaconazole within patients on PPI with
or without concomitant use of the acidic beverage in hematopoietic stem-cell
transplantation patients with graft versus host disease.
Secondary outcome
To investigate whether the plasma concentrations of posaconazole in
graft-versus-host-disease (GVHD) patients, adversely affected by the
co-administration of proton pump inhibitors (PPIs), can be restored by the
acidic beverage.
Feasibility of concomitant administration of posaconazole and the acidic
beverage in GVHD patients. Plasma pharmacokinetics of posaconazole at the start
and at steady-state in graft-versus-host-disease (GVHD) patients concomitantly
using PPI.
Background summary
Antifungal prophylaxis with posaconazole in graft versus host disease patients
may be less efficient due to interactions with PPIs, however this has not been
tested in these patients. As posaconazole adsorption is pH dependent and
adequate levels of posaconazole are important for its antifungal efficacy, a
study that will evaluate the effects of the addition of an acidic beverage to
posaconazole in allogeneic stem cell transplant patients co-treated with PPIs
who have developed GVHD is proposed.
Study objective
to investigate whether the bioavailability of posaconazole in
graft-versus-host-disease (GVHD) patients, adversely affected by the
coadministration of proton pump inhibitors (PPIs), can be restored by an
acidic beverage
Study design
a phase IV open label non randomized prospective comparative trial
Intervention
200mL of an acidic beverage (Coca Cola) will be administered concomitantly with
posaconazole and PPI intake for a period of 7 days until a new steady state has
been reached
Study burden and risks
The patients burden consists of a total of four days of blood sampling in the
VU University medical center after posaconazole and PPI intake at day one (2-8
samples) and at steady state (reached after 6-7 days of posaconazole and PPI
use, 1 sample), repeated after concomitant administration of an acidic beverage
(200mL the acidic beverage) in a cross-over design.
In daily practice GVHD patients often use both posaconazole and PPI and because
adequate levels of posaconazole are important for its antifungal efficacy, it
seems highly relevant for this group to evaluate wether the interaction between
posaconazole and PPI can be restored by an acidic beverage. As no essential
change in treatment regimen will be made besides the addition of the acidic
beverage and the main intervention will be blood sampling, risks are considered
negligible.
de Boelelaan 1117
1081 hv amsterdam
NL
de Boelelaan 1117
1081 hv amsterdam
NL
Listed location countries
Age
Inclusion criteria
*recipients of hematopoietic stem-cell transplantation (HSCT) with graft versus host disease (GVHD) using PPI
*start or use of posaconazole for invasive fungal infection (IFI) prophylaxis with concomitant PPI use for at least twelve days or one week when already using posaconazole
Exclusion criteria
*current clinical significant invasive fungal infection requiring treatment
*inability to sign informed consent
*inability to take oral medication
*allergy to posaconazole, PPI or the acidic beverage
*start or discontinuation of a CYP3a4 inhibitor or P-glycoprotein inducer during the study period
*age < 18 years
*grade II or more diarrhea, mucositis, vomiting
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34167.029.11 |