Use of co-trimoxazole to prevent pneumonia in patients with severe head injury

INTERVENTION: Trade Name: Septrin Product Name: Co‐trimoxazole Pharmaceutical Form: Solution for injection/infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous drip use (Noncurrent) Product Name: 0.9% sodium chloride Pharmaceutical Form: Solution for injection/infusion CONDITION: Pneumonia secondary to severe head injury. ; MedDRA version: 17.1 Level: LLT Classification code 10066724 Term: Acute pneumonia System Organ Class: 100000004862 Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective: Assess the feasibility of conducting a randomised controlled trial:; 1) Establish the likely recruitment rate; 2) Determine the incidence of ventilator associated pneumonia; Primary end point(s): Establish the recruitment rate; Establish the incidence of VAP; Secondary Objective: 1) Determine whether the process of consent is satisfactory; 2) Determine the size of any reduction in the incidence of ventilator associated pneumonia; 3) Determine the likely sample size needed Timepoint(s) of evaluation of this end point: Within 14 days of randomisation. SECONDARY OUTCOME: Secondary end point(s): Determine whether the process of consent is satisfactory; Determine the size of any treatment effect; Determine the likely sample size needed Timepoint(s) of evaluation of this end point: Determine whether the process of consent is satisfactory ‐ recruitment of last patient.; Determine the size of any treatment effect ‐ 6 month mortality, use of antibiotics during ICU stay, number of ventilated days.; Determine the likely sample size ‐ completion of recruitment. 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