Use of a respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in patients with severe confirmed COVID-19 pneumonia

Use of a respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in patients with severe confirmed COVID-19 pneumonia : a multicenter, parallel-group, open-label, randomized controlled trial - MULTI-COV

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001324-33-FR

Enrollment

194

Registered

2020-03-29

Start date

2020-04-09

Completion date

Unknown

Last updated

2021-06-07

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

Conditions

Severe confirmed COVID-19 pneumonia MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862

Interventions

Trade Name: Antimicrobial therapy (antibiotics) Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adults (>= 18 years) admitted to the ICU; - Severe confirmed COVID-19 pneumonia, defined by i) a newly-appeared pulmonary parenchymal infiltrate; and ii) a positive RT-PCR (either upper or lower respiratory tract) for COVID-19 (SARS-CoV-2); iii) and admission to the ICU or intermediate care unit; - Informed consent or emergency procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 97 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 97

Exclusion criteria

Exclusion criteria: - Pregnancy and breastfeeding women ; - Congenital immunodeficiency; - HIV infection with CD4 count below 200/mm3 or unknown in the last year; - High-grade hematological malignancy; - Neutropenia (<1 leucocyte/mL or < 0.5 neutrophil/mL); - Immunosuppressive drugs within the previous 30 days, including anti-cancer cytotoxic chemotherapy and anti-rejection drugs for organ/bone marrow transplant; - Moribund patient or death expected from underlying disease during the current admission; - Patient deprived of liberty or under legal protection measure.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of a management strategy combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin, on antibiotics exposure, as compared with a conventional strategy, in severe confirmed COVID-19 pneumonia.;Secondary Objective: Mortality rates at 28 (D28) and 90 days (D90); - Overall antibiotics use, including broad- and narrow-spectrum antibiotics; - Total exposure to antibiotics at D28; - Number of organ-failure free days at D28; - Incidence rates of bacterial super-infections and colonization/infection with resistant pathogens at D28; - ICU and hospital lengths of stay; - Quality of life at D90.;Primary end point(s): The primary assessment criterion is the number of antibiotic free days at D28, which corresponds to the number of days alive without any antibiotic at Day 28. The D28 time point is usual in studies assessing antibiotic use in ICU patients.;Timepoint(s) of evaluation of this end point: D28	—

Measure

Time frame

Main Objective: To assess the efficacy of a management strategy combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin, on antibiotics exposure, as compared with a conventional strategy, in severe confirmed COVID-19 pneumonia.;Secondary Objective: Mortality rates at 28 (D28) and 90 days (D90); - Overall antibiotics use, including broad- and narrow-spectrum antibiotics; - Total exposure to antibiotics at D28; - Number of organ-failure free days at D28; - Incidence rates of bacterial super-infections and colonization/infection with resistant pathogens at D28; - ICU and hospital lengths of stay; - Quality of life at D90.;Primary end point(s): The primary assessment criterion is the number of antibiotic free days at D28, which corresponds to the number of days alive without any antibiotic at Day 28. The D28 time point is usual in studies assessing antibiotic use in ICU patients.;Timepoint(s) of evaluation of this end point: D28

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Secondary

Measure	Time frame
Secondary end point(s): The secondary assessment criteria are: - Mortality rates at D28 and D90; - Number of defined daily dose (DDD) per 100 patient-days of broad- and narrow-spectrum antibiotics; - Antibiotics duration at D28; - Number of organ-failure free days (based on SOFA) at D28; - Incidence rates of bacterial super-infections at D28; Incidence rates of colonization/infection with multidrug resistant bacteria and Clostridium difficile infections at D28; - ICU and hospital lengths of stay; - Quality of life at D90, assessed using a quality of life questionnaire (EQ5D5L).;Timepoint(s) of evaluation of this end point: D28 and D90	—

Measure

Time frame

Secondary end point(s): The secondary assessment criteria are: - Mortality rates at D28 and D90; - Number of defined daily dose (DDD) per 100 patient-days of broad- and narrow-spectrum antibiotics; - Antibiotics duration at D28; - Number of organ-failure free days (based on SOFA) at D28; - Incidence rates of bacterial super-infections at D28; Incidence rates of colonization/infection with multidrug resistant bacteria and Clostridium difficile infections at D28; - ICU and hospital lengths of stay; - Quality of life at D90, assessed using a quality of life questionnaire (EQ5D5L).;Timepoint(s) of evaluation of this end point: D28 and D90

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Countries

France

Contacts

Public ContactPôle Promotion - DRCI

ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (AP-HP)

aurelie.zindjirdjian@aphp.fr+33144841764

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026