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Pilot randomized controlled trial of the prevention of early respiratory tract infections in intubated patients. Comparison of the safety and efficacy of a short course of systemic antibiotic, a cough simulator and aspiration of subglottic secretions

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521454-42-00
Acronym
PIRAMIDES (24/096-E)
Enrollment
60
Registered
2025-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-21

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

Conditions

cardiac arrest or other causes., Reduced level of consciousness associated with severe trauma, stroke, traumatic brain injury

Brief summary

Incidence of device (cough simulator and subglottic aspiration equipment), antibiotic and infection-related severe adverse events from inclusion to day 14, Incidence of respiratory tract infections (pneumonia and tracheobronchitis) in intubated critically ill patients from inclusion to day 14

Detailed description

Duration of intubation (days with endotracheal tube plus tracheostomy canula) at 90 days, Total days of respiratory support (expressed as days without invasive and non-invasive mechanical ventilation or high-flow nasal canula) at 90 days, Days of ICU-stay, Points of the modified Rankin score on day 90, Day 90 mortality, Days without receiving systemic antibiotic therapy on day 14, Percentage of positive bacterial cultures of respiratory samples during first 14 days, Type of bacterial isolates (Gram-negatives/positives, community/nosocomial) in respiratory samples at day 14, Bacterial resistance mechanisms identified in cultures (extended-spectrum betalactamases, carbapenemases and methicillin, vancomycin, linezolid resistance) in respiratory or any other location until day 14.), Percentage of subjects with bood-stained respiratory secretions, Number of daily catheter secretion suctioning sessions until day 14

Interventions

DRUGCEFTRIAXONA SALA 1 g Polvo para solución inyectable y para perfusión EFG

Sponsors

Hospital Clinico San Carlos
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of device (cough simulator and subglottic aspiration equipment), antibiotic and infection-related severe adverse events from inclusion to day 14, Incidence of respiratory tract infections (pneumonia and tracheobronchitis) in intubated critically ill patients from inclusion to day 14

Secondary

MeasureTime frame
Duration of intubation (days with endotracheal tube plus tracheostomy canula) at 90 days, Total days of respiratory support (expressed as days without invasive and non-invasive mechanical ventilation or high-flow nasal canula) at 90 days, Days of ICU-stay, Points of the modified Rankin score on day 90, Day 90 mortality, Days without receiving systemic antibiotic therapy on day 14, Percentage of positive bacterial cultures of respiratory samples during first 14 days, Type of bacterial isolates (Gram-negatives/positives, community/nosocomial) in respiratory samples at day 14, Bacterial resistance mechanisms identified in cultures (extended-spectrum betalactamases, carbapenemases and methicillin, vancomycin, linezolid resistance) in respiratory or any other location until day 14.), Percentage of subjects with bood-stained respiratory secretions, Number of daily catheter secretion suctioning sessions until day 14

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026