A pilot randomised control trial, in intensive care patients, comparing seven days versus two days treatment with empirical antibiotics to treat hospital acquired infection of unknown origin - Randomised Empirical Antibiotic Duration in Intensive Care Unit
- Conditions
- Healthcare associated infections This includes infections of the: • Skin and underneath the skin, including muscle - sometimes called ‘soft tissue’ • Urinary tract - including your kidneys or bladder • Lungs - which affect your breathing • Joints and bones - including your hips or knees . Blood - sometimes called ‘septacaemia’ . Meningitis
- Registration Number
- EUCTR2009-015800-25-GB
- Lead Sponsor
- The Liverpool Heart & Chest Hospital NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Patients in the intensive care unit with signs suggestive of new infection in the absence of positive microbiological cultures
AND
At least two of the four markers of systemic inflammatory response syndrome (SIRS):
•temperature of >380C or <360C
•tachycardia (>90 beats per minute)
•tachypnoea (= 20 breaths per minute)
•white blood count >12x109/L or <4x109/L
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Positive microbiological cultures before randomisation
•Patients <18 years of age
•Unable to obtain assent or consent
•Patients enrolled in another study such that randomisation in READ-ICU would result in deviation from either protocol
•Known allergy to treatment antibiotics
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method