Defining Antibiotic Treatment Duration for Ventilator - Associated Lung Infection

• Register: ClinicalTrials.gov
• Last refreshed on: 29 January 2024
• Main ID: NCT03382548
• Date of registration: 08/12/2017
• Prospective Registration: Yes
• Primary sponsor: University of Oxford
• Public title: Defining Antibiotic Treatment Duration for Ventilator - Associated Lung Infection REGARD_VAP
• Scientific title: Reducing Antibiotics Treatment Duration for Ventilator-Associated Pneumonia
• Date of first enrolment: February 21, 2018
• Target sample size: 460
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03382548
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Nepal, Singapore, Thailand

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients 18 years and older

2. Invasive mechanical ventilation = 48 hours

3. Satisfy the US Centers for Disease Control and Prevention National Healthcare Safety
Network VAP diagnostic criteria

- At least one of the following:

1. temperature > 38 °C

2. white blood cell count = 12,000 cells/mm3 or = 4,000 cells/mm3

3. 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:

1. new and progressive OR progressive and persistent infiltrate

2. new and persistent OR progressive and persistent consolidation

3. new and persistent OR progressive and persistent cavitation, AND

- At least two of the following:

1. new onset of purulent sputum, or change in character of sputum, or increased
respiratory secretions, or increased in suctioning requirements

2. new onset or worsening tachypnea or dyspnea

3. rales or bronchial breath sounds

4. worsening gas exchange defined by oxygen desaturations (e.g., PaO2/FiO2
<240), increased oxygen requirements or increased ventilation demand

Exclusion Criteria:

1. Poor likelihood of survival as defined by a Sepsis-related Organ Failure Assessment
score (SOFA score) of >11 points

2. 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)

3. 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)

4. Patients who have been treated for VAP for more than 7 days from screening

5. Vulnerable population including prisoners and refugees



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ventilator Associated Pneumonia

Pneumonia, Bacterial

Intervention(s)

Drug: Reducing Antibiotics treatment duration

Drug: Standard Antibiotics treatment duration

Primary Outcome(s)

Proportion of patients who suffered either death or pneumonia recurrence within 60(±5) days of enrolment [Time Frame: 60 days]

Secondary Outcome(s)

Duration of mechanical ventilation [Time Frame: 60 days]

Financial costs [Time Frame: 3 years]

Proportion of patients who acquired multidrug resistant infection or colonisation within 60(±5) days of enrolment [Time Frame: 60 days]

Proportion of patients who suffered ventilator-associated events within 60(±5) days of enrolment [Time Frame: 60 days]

Route of transmission of MDR Gram-negatives in ICUs by comparing genomic sequencing data [Time Frame: 3 years]

Number and types of extrapulmonary infections during hospitalisation (determined from cultures taken from sterile sites) [Time Frame: 60 days]

Characteristics of microbiota in terms of shifts in functional and metabolic capacity by comparing alpha and beta diversity metrics between the groups of patients [Time Frame: 3 years]

Duration of hospitalization [Time Frame: 60 days]

Number of days of antibiotics during hospitalization [Time Frame: From 3 months before to 60 days after enrolment]

Quality Adjusted Life Years (QALY) loss [Time Frame: 3 years]

Relative abundance of the genera in the microbiota between the groups of patients [Time Frame: 3 years]

Secondary ID(s)

BAC17008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mahidol Oxford Tropical Medicine Research Unit

Department for International Development, United Kingdom

Medical Research Council