Use of antibiotics (co-trimoxazole) to prevent pneumonia following severe head injury.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005430-37-GB

Enrollment

Registered

2014-11-14

Start date

2015-01-02

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia secondary to severe head injury. MedDRA version: 17.1 Level: LLT Classification code 10066724 Term: Acute pneumonia System Organ Class: 100000004862

Interventions

Trade Name: Septrin Product Name: Co-trimoxazole Pharmaceutical Form: Solution for injection/infusion Pharmaceutical form of the placebo: Solution for i

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 ; 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 ; Primary end point(s): Establish the recruitment rate Establish the incidence of VAP ;Timepoint(s) of evaluation of this end point: Within 14 days of randomisation.	—

Measure

Time frame

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 ; 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 ; Primary end point(s): Establish the recruitment rate Establish the incidence of VAP ;Timepoint(s) of evaluation of this end point: Within 14 days of randomisation.

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Secondary

Measure	Time frame
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. ; 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	—

Measure

Time frame

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. ; 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

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026