Status:
COMPLETED
Defining Antibiotic Treatment Duration for Ventilator - Associated Lung Infection
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Medical Research Council
Department for International Development, United Kingdom
Conditions:
Ventilator Associated Pneumonia
Pneumonia, Bacterial
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Intensive care units (ICUs), with high antibiotic consumption, are epicentres of antimicrobial resistance (AMR). Ventilator associated pneumonia (VAP) is the commonest hospital-acquired infection (HAI...
Eligibility Criteria
Inclusion
- Patients 18 years and older
- Invasive mechanical ventilation ≥ 48 hours
- Satisfy the US Centers for Disease Control and Prevention National Healthcare Safety Network VAP diagnostic criteria
- At least one of the following:
- temperature \> 38 °C
- white blood cell count ≥ 12,000 cells/mm3 or ≤ 4,000 cells/mm3
- altered mental status with no other causes in \>70 year-olds; AND
- Two or more chest imaging tests demonstrating at least one of the following:
- new and progressive OR progressive and persistent infiltrate
- new and persistent OR progressive and persistent consolidation
- new and persistent OR progressive and persistent cavitation, AND
- At least two of the following:
- new onset of purulent sputum, or change in character of sputum, or increased respiratory secretions, or increased in suctioning requirements
- new onset or worsening tachypnea or dyspnea
- rales or bronchial breath sounds
- worsening gas exchange defined by oxygen desaturations (e.g., PaO2/FiO2 \<240), increased oxygen requirements or increased ventilation demand
Exclusion
- Poor likelihood of survival as defined by a Sepsis-related Organ Failure Assessment score (SOFA score) of \>11 points
- Immunocompromised patients (HIV with CD4 \<200 cells/mm3, corticosteroids\> 0.5 mg/kg per day for \> 30 days, received chemotherapy in the past 3 months, solid organ or hematopoietic cell transplant)
- Patients receiving antibiotic therapy for any other defined extra-pulmonary infections that warrant a duration of antibiotics longer than 7 days, or complications of pneumonia such as lung abscess or empyema, that warrant a duration of antibiotics longer than 7 days (excluding anti-tuberculosis treatment, antifungal medications, antibiotics meant for chronic suppression of chronic infections or chronic obstructive lung disease)
- Patients who have been treated for VAP for more than 7 days from screening
- Vulnerable population including prisoners and refugees
Key Trial Info
Start Date :
February 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2023
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT03382548
Start Date
February 21 2018
End Date
March 22 2023
Last Update
January 18 2024
Active Locations (7)
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1
Civil Hospital
Kathmandu, Nepal
2
Patan Academy of Health Science, Patan Hospital, Kathmandu
Patan, Nepal
3
National University Hospital, Singapore
Singapore, Singapore
4
Tan Tock Seng Hospital
Singapore, Singapore