Health TrialsbyHealthPanel

Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT)

ConditionVentilator Associated Pneumonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Bari

About this trial

PROACT study aims to resolve uncertainties to influence actual practice guidelines or public health policing regarding VAP prevention in ICU by using probiotics administration.

Multi-trauma patients with a head injury OR stroke or brain haemorrhage patients without any sign of aspiration and lung infection will be enrolled and randomized to either placebo or probiotic treatment to assess if VAP and mortality can be reduced in the interventional group.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adults aged 18-80 years

at least one of the following conditions: a) recent trauma involving head injury and at least one more organ system; b) stroke or brain hemorrhage without any sign of aspiration and lung infection

intubation and start of mechanical ventilation. This needs to start immediately after the event described in the inclusion criteria (b). For cases of head trauma this is defined as start in the ambulance or the emergency department

likelihood that the duration of mechanical ventilation would be at least six days

Disqualifiers

has received mechanical ventilation more than 72 hours from start of screening

pregnancy or Lactation

patients at risk of iatrogenic probiotic infection e.g. immunosuppression which includes

HIV <200 CD4 cells/μL

Trial design

Design model

Parallel

Treatments tested in this trial

  • LactoLevure

    Dietary supplement

    Patients will receive two capsules, twice daily for 30 days, one through the nasogastric tube and one spread on the oropharynx. The probiotic capsules look identical to the placebo capsules; the powder will be similar when opened. The capsule for nasogastric tube will be opened and suspended in 100 ml of tap water. The capsule for the oropharynx will be opened and suspended in sterile water based surgical lubricant. The administration must happen at least 30 minutes after oral antiseptic product usage (e.g. daily chlorhexidine oral care), which otherwise might neutralize the study supplement's action.

  • Placebo

    Other intervention

    Patients will receive two capsules, twice daily for 30 days, one through the nasogastric tube and one spread on the oropharynx. The placebo capsules contain a powdered glucose polymer that is unharmful for the patient and will be provided by the sponsor. The placebo capsules look identical to the probiotic capsules; the powder will be similar when opened. The capsule for nasogastric tube will be opened and suspended in 100 ml of tap water. The capsule for the oropharynx will be opened and suspended in sterile water based surgical lubricant. The administration must happen at least 30 minutes after oral antiseptic product usage (e.g. daily chlorhexidine oral care), which otherwise might neutralize the study supplement's action.

Treatment groups

186 Participants
are divided into 2 treatment groups
Group A: Interventional: ProbioticsExperimental treatment 1 intervention
Group B: Control: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Vap Incidence

VAP is defined as first episode of lower respiratory tract infection that meets all the following criteria: (a) onset \>48 h after initiation of mechanical ventilation; (b) increase in SOFA score by ≥1 point; (c) new infiltrate in chest X-ray or chest computed tomography; (d) core temperature \>38°C; (e) purulent tracheobronchial secretions; (f) clinical pulmonary infection score (CPIS) \>6 ; and (g) isolation of a pathogen from BAL fluid (\>1 × 104 cfu/mL) or tracheal aspirate (\>1 × 105 cfu/mL) . This is analyzed for the ITT population. The ITT comprises the total of enrolled and randomized patients.

Time frame
45 days

Secondary outcomes

1

Vap incidence analyzed for mITT

The mITT comprised only patients with less than 102 cfu/ml of bacterial growth in tracheobronchial secretions before start of the study drug.

Time frame
45 days
2

Sepsis

Sepsis is defined as a new infection with at least a 2-point increase in the total SOFA score. The endpoint will be analyzed for both the ITT and mITT populations.

Time frame
45 days
3

Septic shock

Septic shock is defined as sepsis aggravated by hypotension and serum lactate level \>2 mmol/L (18 mg/dL) that requires vasopressors administration despite adequate volume resuscitation. The endpoint will be analyzed for both the ITT and mITT populations.

Time frame
45 days
4

Catheter-related bloodstream infections (CRBSI)

CRBSI, according to the Infectious Diseases Society of America, is defined when one of the following criteria is met 1) Isolation of the same pathogen from a quantitative blood culture drawn through the central line and from a peripheral vein with the single bacterial colony count at least threefold higher in the sample from the central line as compared to that obtained from a peripheral vein 2) same organism recovered from percutaneous blood culture and from quantitative (\>15 colony-forming units) culture of the catheter tip 3) a shorter time to positive culture (\>2 hours earlier) in the central line sample than the peripheral sample (differential time to positivity \[ DTP \]). The endpoint will be analyzed for both the ITT and mITT populations.

Time frame
45 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bari

Lead sponsor

Uni-Pharma

Collaborator

Source ClinicalTrials.gov
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