Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
60
Countries
1
Sites
1
Reduced level of consciousness associated with severe trauma, traumatic brain injury, stroke, cardiac arrest or other causes.
Study the incidence of device, antibiotic and infection-associated severe adverse events, days 1 to 14. Prevention of respiratory tract infections in intubated critically ill patients from inclusion to day 14.
Key facts
- Sponsor
- Hospital Clinico San Carlos
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Bacterial Infections and Mycoses [C01], Health Care [N] - Health Care Quality, Access, and Evaluation [N05]
- Decision date (initial)
- 2025-05-21
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Direx. Spain/Yaguo Technology Co. Ltd. provide the cough simulation device and consumables. · Libera Médica. Spain provides subglottic aspiration device and endotracheal tubes
External identifiers
- EU CT number
- 2025-521454-42-00
- ClinicalTrials.gov
- NCT06113939
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
Study the incidence of device, antibiotic and infection-associated severe adverse events, days 1 to 14.
Prevention of respiratory tract infections in intubated critically ill patients from inclusion to day 14.
Secondary objectives 11
- Duration of endotracheal intubation over 90 days
- Duration of respiratory support
- Length of ICU-stay
- Modified Rankin score on day 90
- Day-90 mortality
- Days without systemic antibiotictherapy at day 14
- Positive bacterial cultures in respiratory samples on day 14
- Type of bacterial isolates in respiratory samples on day 14
- Bacterial resistance mechanisms identified in cultures by day 14
- Blood-stained respiratory secretions
- Number of daily catheter secretion suctioning sesions
Conditions and MedDRA coding
Reduced level of consciousness associated with severe trauma, traumatic brain injury, stroke, cardiac arrest or other causes.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10036654 | Prevention | 10042613 |
| 20.0 | PT | 10060946 | Pneumonia bacterial | 100000004862 |
| 20.0 | HLT | 10052770 | Coma states | 10029205 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Prevention of Infections of the Respiratory Tract 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
|
Randomised Controlled | None | Control: Standard of care, includes 3 days of 2 gram iv ceftriaxone and conventional catheter open suctioning of respiratory secretions. Continuous subglottic aspiration: Continuous aspiration of subglottic secretions with an endotracheal tube designed for aspiration of secretions accumulating above its cuff. Mechanical exsufflation: Intermittent aspiration with a device simulating spontaneous cough by generating a high peak expiratory air flow aimed at dragging respiratory secretions proximally. |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- Data will only be shared upon reasonable request after publication of the main manuscript.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-512085-34-00 | 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 | Hospital Clinico San Carlos |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Endotracheal Intubation anticipated to last >48 hours
- Age >17
- Severe trauma or severe head trauma or Ischemic or hemorrhagic stroke or Status after cardiac arrest (ROSC) or Intoxications of the CNS or status epilepticus
Exclusion criteria 6
- Hopeless prognosis
- Indication of systemic antibiotic therapy for suspected or documented infection
- Active hemoptisis or pulmonary hemorrhage
- Unstable thoracic cage
- Undrained pneumothorax (inclusion acceptable after drainge)
- Betalactam allergy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- 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 endpoints 11
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
CEFTRIAXONA SALA 1 g Polvo para solución inyectable y para perfusión EFG
PRD346412 · Product
- Active substance
- Ceftriaxone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2 g gram(s)
- Max total dose
- 6 g gram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DD04 — -
- Marketing authorisation
- 64.951
- MA holder
- LABORATORIO REIG JOFRE, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Clinico San Carlos
- Sponsor organisation
- Hospital Clinico San Carlos
- Address
- Calle Del Profesor Martin Lagos Sn
- City
- Madrid
- Postcode
- 28040
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Clinico San Carlos
- Contact name
- Servicio de Medicina Intensiva
Public contact point
- Organisation
- Hospital Clinico San Carlos
- Contact name
- Servicio de Medicina Intensiva
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_en_CT-2025-521454-42-00 | 2 |
| Protocol (for publication) | D1_Protocolo_es_CT-2025-521454-42-00 | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment_Arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_CT_2025-521454-42_Consentimiento_Informado_PIRAMIDES | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | rocephin-article-30-referral-annex-iii_en | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_en_CT_2025-521454-42-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Sinopsis_Protocolo_es_CT-2025-521454-42-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-04 | Spain | Acceptable 2025-05-21
|
2025-05-21 |