Is treatment A: cefotaxime parenteral twice daily 1 gram during four days as effective as treatment B: cefotaxime parenteral four times daily 1 gram in preventing airway colonisation by potential pathogenic microorganisms.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is airway colonisation by potential pathogenic
microorganisms after four days of selective decontamination of the digestive
tract.
Secondary outcome
Secondary study parameters are length of stay on the ICU, length of stay in the
hospital, ICU mortality, hospital mortality, duration of mechanical ventilation
and pneumonia during ICU admission following the criteria of the Centers for
Disease Control.
Background summary
Selective decontamination of the digestive tract (SDD) is a strategy that aims
to prevent 2 types of endogenic pneumonia caused by endogenic flora of the
digestive tract or hospital acquired nosocomial bacteria. Primary endogenic
pneumonia, the most common infection on the ICU, can only be prevented by
administering parenteral antibiotics (cefotaxime) directly at admission. At the
moment cefotaxime 4 times a day 1 gram during 4 days is the antibiotic of
choice in the Netherlands. After 4 days the parenteral antibiotic is
whitdrawed, as it is shown that the majority of patients have no airway
colonisation of potential pathogenic microorganisms after 4 days. From this
moment on the oral antibiotics of the SDD regime have their effect. SDD is a
profylactic regime, not a therapeutic regime. Interesting in this context is
that pneumonia can be treated effectively with cefotaxime twice daily 1 gram.
This dose regime has not been tested in the context of SDD.
Study objective
Is treatment A: cefotaxime parenteral twice daily 1 gram during four days as
effective as treatment B: cefotaxime parenteral four times daily 1 gram in
preventing airway colonisation by potential pathogenic microorganisms.
Study design
The study design is a randomised single blind study at an intensive care unit
during a period of two years. Patients are assigned to group A or group B by
randomisation. Patients assigned to group A will receive cefotaxime two times a
day and a placebo two times a day during four days. Patients assigned to group
B will receive cefotaxime four times a day during four days (standard therapy).
On the first day (before supplementing the study therapy) and on the fourth day
cultures of endotracheal aspirates and oropharynx are obtained. The presence of
potential pathogenic microorganisms in the cultures will be compared between
the two study groups.
Study burden and risks
The burden of participation is small for the patient, since culture collection
is part of the standard therapy.
Lijnbaan 32
2512 VA Den Haag
Nederland
Lijnbaan 32
2512 VA Den Haag
Nederland
Listed location countries
Age
Inclusion criteria
All patients expected to be intubated for more than 24 hours.
All non-intubated patiënts who are expected to receive enteral tube feeding for more than 48 hours.
Exclusion criteria
Pneumonia at admission on the ICU
Expected death within 48 hours
Immunocompromised patients
Pregnancy
Antibiotic therapy within the last 48 hours before admission at the ICU
No informed consent within 24 hours after admission at the ICU
Cephalosporin allergy
ICU admission in the previous 30 days
Age below 18 years
Design
Recruitment
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 | NL28078.098.09 |