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Use of MULTIplex PCR, procalcitonin and the appearance of sputum to reduce the duration of antibiotic therapy during severe COPD EXAcerbation: a trial controlled, randomized, open, in parallel groups, multicenter (MULTI-EXA)

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511896-13-00
Acronym
APHP210085
Enrollment
204
Registered
2024-10-31
Start date
2022-12-09
Completion date
Unknown
Last updated
2025-01-28

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

Conditions

EA-COPD (with mechanical ventilation, invasive or non-invasive, or high-flow nasal oxygen therapy).

Brief summary

Number of days alive without antibiotics on D28.

Detailed description

Number of days with antibiotics in patients alive on D28, Number of days with broad-spectrum antibiotics in patients alive on D28, Incidence rate of nosocomial pneumonia on day 28;, Incidence rate of colonization/infection with multi-resistant bacteria on day 28;, Duration of stay in ICU/ICU at D28,, Length of hospital stay on D28;, Number of days alive without mechanical ventilation on D28, - Incidence rate of hospital-acquired pneumonia (including ventilator-acquired pneumonia) on day 28;, Mortality in ICU/ICU and in hospital (on day 28 and day 90);, - Number of additional EA-COPD(s) (requiring hospitalization and/or initiation of systemic corticosteroid therapy and/or antibiotic therapy) after the index EA-COPD (at D90);, Time between the index EA-COPD and the next EA-COPD (EA-COPD requiring hospitalization and/or initiation of systemic corticosteroid therapy and/or antibiotic therapy) (at D90);, CAT questionnaire (COPD Assessment Test) (at D90).

Interventions

DRUGCEFOTAXIME
DRUGAMOXICILLIN
DRUGCIPROFLOXACIN

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of days alive without antibiotics on D28.

Secondary

MeasureTime frame
Number of days with antibiotics in patients alive on D28, Number of days with broad-spectrum antibiotics in patients alive on D28, Incidence rate of nosocomial pneumonia on day 28;, Incidence rate of colonization/infection with multi-resistant bacteria on day 28;, Duration of stay in ICU/ICU at D28,, Length of hospital stay on D28;, Number of days alive without mechanical ventilation on D28, - Incidence rate of hospital-acquired pneumonia (including ventilator-acquired pneumonia) on day 28;, Mortality in ICU/ICU and in hospital (on day 28 and day 90);, - Number of additional EA-COPD(s) (requiring hospitalization and/or initiation of systemic corticosteroid therapy and/or antibiotic therapy) after the index EA-COPD (at D90);, Time between the index EA-COPD and the next EA-COPD (EA-COPD requiring hospitalization and/or initiation of systemic corticosteroid therapy and/or antibiotic therapy) (at D90);, CAT questionnaire (COPD Assessment Test) (at D90).

Countries

France

Outcome results

None listed

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