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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

9 Dec 2022 → ongoing

Decision date (initial)

2024-10-31

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Ministry of Health

External identifiers

EU CT number

2024-511896-13-00

EudraCT number

2021-005435-23

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Evaluate the effectiveness in terms of antibiotic sparing of a personalized diagnostic and therapeutic strategy, compared to a usual strategy, during EA-COPD in the ICU/Rea.

Secondary objectives 1

1. evaluate the effectiveness and safety of the tested strategy, compared to a usual strategy.

Conditions and MedDRA coding

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age ≥ 18 years old
2. Post-smoking COPD confirmed according to GOLD 2020, whatever the stage (I-IV)
3. Acute exacerbation (defined by the appearance or increase of one or more of the usual signs/symptoms of COPD) with acute respiratory failure requiring admission to the ICU/Resuscitation and mechanical ventilation (invasive or non-invasive or nasal oxygen therapy high flow rate with FiO2 ≥ 50%)
4. Consent (patient, relative or inclusion in emergency situation)
5. Affiliation to a social security scheme.

Exclusion criteria 10

1. Delay between admission to hospital and admission to ICU/ICU greater than 3 days
2. Antibiotic therapy formally indicated for a suspected or documented extra-respiratory infection
3. Congenital or acquired immunosuppression (congenital immune deficiency, progressive high-grade hematological malignancy, immunosuppressive drugs in the last 30 days including cytotoxic anti-cancer chemotherapy and anti-rejection drugs, corticosteroid therapy ≥ 20 mg/d of prednisone equivalent for at least 14 days, neutropenia, HIV with unknown or known CD4<200/µL in the last 6 months)
4. Tracheotomy
5. Bronchial dilatation/cystic fibrosis
6. Moribund patient (imminent death)
7. Patient deprived of liberty and/or protected by law
8. Patient already included in MULTI-EXA
9. Patient already included in a type 1 interventional clinical study (RIPH1) relating to antibiotics
10. Current pregnancy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number of days alive without antibiotics on D28.

Secondary endpoints 12

1. Number of days with antibiotics in patients alive on D28
2. Number of days with broad-spectrum antibiotics in patients alive on D28
3. Incidence rate of nosocomial pneumonia on day 28;
4. Incidence rate of colonization/infection with multi-resistant bacteria on day 28;
5. Duration of stay in ICU/ICU at D28,
6. Length of hospital stay on D28;
7. Number of days alive without mechanical ventilation on D28
8. - Incidence rate of hospital-acquired pneumonia (including ventilator-acquired pneumonia) on day 28;
9. Mortality in ICU/ICU and in hospital (on day 28 and day 90);
10. - 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);
11. 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);
12. CAT questionnaire (COPD Assessment Test) (at D90).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Stanislas Quenard

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Stanislas Quenard

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications