se of antibiotics (co-trimoxazole) to prevent pneumonia following severe head injury.
Phase 1
- Conditions
- Pneumonia secondary to severe head injury.MedDRA version: 17.1 Level: LLT Classification code 10066724 Term: Acute pneumonia System Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2013-005430-37-GB
- Lead Sponsor
- orth Bristol NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Patients over 18 years of age with traumatic brain injury requiring mechanical ventilation (artificial respiration) which is anticipated to continue for greater than 48 hours.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
Known or suspected allergy to co-trimoxazole.
Known blood disorder: megaloblastic anaemia, acute porphyria.
Pre-existing severe respiratory disease (APACHE II definition).
Severe liver disease.
Renal impairment (eGFR <30 ml/min/1.73m2).
Not expected to survive 48 hours.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: Assess the feasibility of conducting a randomised controlled trial:<br> 1) Establish the likely recruitment rate<br> 2) Determine the incidence of ventilator associated pneumonia<br> ;<br> Secondary Objective: 1) Determine whether the process of consent is satisfactory<br> 2) Determine the size of any reduction in the incidence of ventilator associated pneumonia<br> 3) Determine the likely sample size needed<br> ;<br> Primary end point(s): Establish the recruitment rate<br> Establish the incidence of VAP<br> ;Timepoint(s) of evaluation of this end point: Within 14 days of randomisation.
- Secondary Outcome Measures
Name Time Method <br> Timepoint(s) of evaluation of this end point: Determine whether the process of consent is satisfactory - recruitment of last patient.<br> Determine the size of any treatment effect - 6 month mortality, use of antibiotics during ICU stay, number of ventilated days.<br> Determine the likely sample size - completion of recruitment.<br> ;<br> Secondary end point(s): Determine whether the process of consent is satisfactory<br> Determine the size of any treatment effect<br> Determine the likely sample size needed<br>