No registrations found.
ID
Source
Brief title
Health condition
SDD, SOD, ICU, antibiotic resistance, selective decontamination
Sponsors and support
Heidelberglaan 100, 3584 CX, Utrecht
phone +31 (0)887555555
Heidelberglaan 100, 3584 CX, Utrecht
phone +31 (0)887555555
Intervention
Outcome measures
Primary outcome
Point prevalence of rectal and respiratory colonization with specificantly defined resistant bacteria (both Gram positive and Gram negative) according to the WIP-guidelines.
Secondary outcome
1. ICU-admission until 48 hours after ICU-discharge, and microbiologically documented;
2. Rate of ICU-acquired bacteraemia caused by antibiotic resistant bacteria, expressed as
the rate per 100 ICU-acquired bacteraemia caused by all pathogens;
3. Mortality; at day 28, ICU- and in-hospital mortality;
4. Length of ICU-stay;
5. Predefined subgroup analysis: mortality (28 days-, IC- and in-hospital mortality) in
two subgroups: surgical and non-surgical patients;
6. Annual use of antibiotics based on pharmacy records.
Background summary
Multicenter, cross-over comparison study of SDD and SOD in ICU settings using
either SDD or SOD for standard care. Results from routinely performed clinical and
surveillance cultures will be used to assess development of antibiotic resistance in different ‘marker’ pathogens.
Study objective
The difference between both interventions is the absence of intestinal decontamination during SOD and the standard use of cephalosporins for all patients during SDD. It has been hypothesized that eradication of the intestinal Gram negative bacterial flora reduces the likelihood of resistance development in Gram negative bacteria.
Study design
Each ICU will be randomized into one of two study arms, starting either with SDD or SOD for twelve months, with cross-over to the other intervention. Before starting the first study period and after the
first period, a wash-out wash-in period (1 month) will be carried out, during which the new treatment (either SDD or SOD) will be implemented, but patient data will not be used for analysis.
Intervention
SDD consists of an oropharyngeal application (every 6 h) of a paste containing colistine, tobramycin and amphotericin B each in a 2% concentration, and administration (every 6 h) of a 10 ml suspension containing colistine, tobramycin and amphotericin B via the nasogastric tube. Topical antibiotics will be applied until ICU-discharge. In addition, cefotaxime (1000 mg, every 6 h) will be administered intravenously during the first four days of study.
SOD consists of oropharyngeal application of the same paste as used for SDD.
Department of Medical Microbiology,
Postal address G.04.5.17
E. Oostdijk
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)88 7555006
e.a.n.oostdijk@umcutrecht.nl
Department of Medical Microbiology,
Postal address G.04.5.17
E. Oostdijk
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)88 7555006
e.a.n.oostdijk@umcutrecht.nl
Inclusion criteria
Patients admitted to ICU with an expected length of ICU stay of 48 hours.
Exclusion criteria
Patients younger than 18 years.
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 |
|---|---|
| NTR-new | NL1679 |
| NTR-old | NTR1780 |
| Other | MEC UMC : 08/097 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |