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ASPIC - Antimicrobial Stewardship for Ventilator Associated Pneumonia in Intensive Care

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513327-16-00
Acronym
APHP200011
Enrollment
590
Registered
2024-09-09
Start date
2022-09-20
Completion date
Unknown
Last updated
2025-09-05

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

Conditions

Intensive care, Ventilator Associated Pneumonia

Brief summary

The primary endpoint is a composite endpoint with non-inferiority criteria including: 1. all-cause mortality (ACM) measured at day 28 after initiation of antibiotic therapy OR 2. Treatment failure defined by signs of pneumonia within 72 hours after the end antibiotic therapy at the test of cure visit OR 3. New episode of microbiologically confirmed VAP from 72 hours after the end antibiotic treatment to day 28 after initiation of VAP antibiotic treatment

Detailed description

1) Rate of all-cause mortality, 2) Rate of treatment failure, 3) Rate of new episode of VAP, 4) Number of antibiotic free alive-days from initiation of VAP antibiotic therapy to day 28, 5) Global score constructed with the DOOR and RADAR. Overall clinical outcome at day 28, from most to least desirable are: 1. Survival, clinical cure 2. Survival, new pulmonary infection 3. Death, 6) Duration of invasive MV, at day 28 after inclusion, defined as total of days under MV, 7) Length of ICU stay at day 28 after inclusion, defined by the number of days between inclusion and ICU discharge or in-ICU death., 8) Rate of VAP recurrence by the intensivist at day 28, 9) Rate of antibiotic related side effects, 10) Rate of acquisition of MDR bacteria at day 28 defined as the identification of a MDR bacteria carriage not present at admission, 11) Rate of death at days 28 and 90 at day 28, 12) Rate of non-interruption of antibiotic therapy despite a positive clinical cure in the intervention group only at day 28 after inclusion., 13) Total cumulative costs of antibiotics at day 28 and incremental cost effectiveness ratio

Interventions

DRUGAMOXICILLINE/ACIDE CLAVULANIQUE PANPHARMA 2 g/200 mg ADULTES
DRUGpoudre pour solution injectable

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is a composite endpoint with non-inferiority criteria including: 1. all-cause mortality (ACM) measured at day 28 after initiation of antibiotic therapy OR 2. Treatment failure defined by signs of pneumonia within 72 hours after the end antibiotic therapy at the test of cure visit OR 3. New episode of microbiologically confirmed VAP from 72 hours after the end antibiotic treatment to day 28 after initiation of VAP antibiotic treatment

Secondary

MeasureTime frame
1) Rate of all-cause mortality, 2) Rate of treatment failure, 3) Rate of new episode of VAP, 4) Number of antibiotic free alive-days from initiation of VAP antibiotic therapy to day 28, 5) Global score constructed with the DOOR and RADAR. Overall clinical outcome at day 28, from most to least desirable are: 1. Survival, clinical cure 2. Survival, new pulmonary infection 3. Death, 6) Duration of invasive MV, at day 28 after inclusion, defined as total of days under MV, 7) Length of ICU stay at day 28 after inclusion, defined by the number of days between inclusion and ICU discharge or in-ICU death., 8) Rate of VAP recurrence by the intensivist at day 28, 9) Rate of antibiotic related side effects, 10) Rate of acquisition of MDR bacteria at day 28 defined as the identification of a MDR bacteria carriage not present at admission, 11) Rate of death at days 28 and 90 at day 28, 12) Rate of non-interruption of antibiotic therapy despite a positive clinical cure in the intervention group onl

Countries

France

Outcome results

None listed

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