A clinical trial to determine if antibiotics prevent chest infections in patients with brain injuries requiring life support in the intensive care unit

Phase 2

Conditions: ower respiratory tract infection
Acute brain injury
Mechanical ventilation
Ventilator associated pneumonia
Lower respiratory tract infection
Infection - Studies of infection and infectious agents
Injuries and Accidents - Other injuries and accidents

Registration Number: ACTRN12623000958684

Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Stopped early

Sex: All

Target Recruitment: 5

Inclusion Criteria

1.Aged greater than or equal to 18 years AND
2.Invasively mechanically ventilated with one or more of the following acute brain injuries/conditions:
(i)Ischaemic stroke
(ii)Intracerebral haemorrhage
(iii)Status epilepticus
(iv)Subarachnoid haemorrhage
(v)Suspected hypoxic ischaemic encephalopathy following resuscitation from cardiac arrest
(vi)Traumatic brain injury.
AND
3.Expected to be invasively ventilated (via endotracheal tube or tracheostomy) in the ICU until at least the day after tomorrow.

Exclusion Criteria

1.Being treated with antibiotics to treat a known or suspected infection
2.Has been treated with antibiotics for a known or suspected infection in the previous 7 days
3.On prophylactic antibiotics except for peri-operative prophylaxis with cephazolin (or the treating clinician intends administering prophylactic antibiotics apart from peri-operative prophylaxis with cephazolin.) (SDD is counted as prophylactic antibiotics for the purposes of this exclusion)
4.More than 12 hours since intubation (or tracheostomy insertion)
5.More than 72 hours since hospital admission
6.Documented allergy or other contraindication to ceftriaxone
7.Death is deemed to be inevitable as a result of the current acute illness and either the treating clinician, the patient or the substitute decision maker are not committed to full active treatment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be administration of antibiotics to treat a presumed early lower respiratory tract infection in the ICU. This outcome will be met if:<br>(i)Antibiotics are commenced to treat a presumed infection during the index ICU admission within seven days (168 hours) of randomisation, determined from hospital records AND<br>(ii)The Principal Investigator (or a delegate) considers, at day seven post randomisation or at ICU discharge (whichever is sooner), that the patient had an infection while in the ICU, and that the lower respiratory tract was a probable source of that infection, ascertained from clinical records or confirmation from treating clinician. [ 7 days following randomisation or at ICU discharge, whichever is sooner.]

Secondary Outcome Measures