To determine the superiority of doxycycline-rifampicin compared to trimethoprim-rifampicin for the decolonization treatment of complicated MRSA carriership.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the success rate of MRSA decolonization. Successful
decolonization is defined as 3 consecutive negative cultures after treatment,
with a minimum interval of 7 days.
Secondary outcome
- The long-term success rate of decolonization treatment of
doxycycline-rifampicin compared to trimethoprim-rifampicin, defined as an
additional set of negative MRSA swabs taken 2 months and 1 year after
decolonization treatment.
- To determine whether there is an association between virulence factors and
success rate of decolonization.
Background summary
MRSA decolonization has proven to prevent infection and reduce transmission. It
has yet remained undecided which combination of anti-staphylococcal agents is
most effective in the treatment of complicated MRSA carriage. A recent cohort
study showed the highest success rate of decolonization in patients treated
with doxycycline-rifampicin (86%) compared to the other antibiotic combinations
(average 69%). However, because of the retrospective study design the validity
of the results is limited. A randomized clinical study is necessary to
determine if doxycycline-rifampicin is superior to other conventional treatment
regimens. The Dutch guideline recommends both doxycycline-rifampicin and
trimethoprim-rifampicin as first choice treatments for decolonization of
complicated MRSA carriage. Therefore trimethoprim-rifampicin will be the
comparator of this study.
Study objective
To determine the superiority of doxycycline-rifampicin compared to
trimethoprim-rifampicin for the decolonization treatment of complicated MRSA
carriership.
Study design
Multicenter open-label cluster randomized controlled trial.
Intervention
Group A: doxycycline 200 mg q.d. - rifampicin 600mg b.i.d. versus Group B:
trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d. All orally, total duration
7 days.
Study burden and risks
MRSA decolonization treatment is already standard clinical practice in the
Netherlands. There is no additional burden or risk associated with
participation in the study. Both antibiotic regimens (in Group A and Group B)
used in the study, are recommended as first-line therapy by the Dutch guideline
for the treatment of MRSA carriage. The study is open label, so there is no
additional risk of blinding. The number of outpatient visits and follow-up
cultures are not different from daily clinical practice in the Netherlands. No
invasive procedures will be performed for the purpose of this study.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
complicated MRSA carriership
Adult
Exclusion criteria
- catheters/drains in situ
- Failure of previous decolonization attempt of complicated MRSA carriage
- Allergy or other contra-indication to either doxycycline, rifampicin or
trimethoprim (these patients will participate in the observational arm)
- Previous participation in this study
- Pregnancy
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL79720.058.21 |