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Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit

NCT ID: NCT05696093

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

628 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-19

Study Completion Date

2026-12-31

Brief Summary

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Efficacy of cotrimoxazole as a de-escalation treatment for adult patients Ventilator-Associated Pneumonia in intensive care unit Multicentre randomized non-inferiority trial comparing cotrimoxazole to standard antibiotic therapy for enterobacterial VAP

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Detailed Description

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Multicentre randomized non-inferiority trial comparing cotrimoxazole to standard antibiotic therapy for enterobacterial VAP. Selection of patients will be done by physicians in ICU. All clinically suspected VAP will be confirmed with a lung sample (preferably bronchoalveolar lavage or protected distal specimen, otherwise endotracheal aspiration). Patients with a microbiologically confirmed VAP due to an Enterobacteriaceae susceptible to cotrimoxazole and at least one antibiotic of the empiric antibiotic therapy (based on international recommendations) will be included. After written informed consent, they will be randomized (1:1), using a computer-generated randomization scheme of various-sized blocks, stratified by presence of septic shock at VAP diagnosis and by presence of COVID-19 pneumonia on ICU admission, through a centralized 24 hours internet service (CleanWEB™) to cotrimoxazole, or best standard of care (either a beta-lactam or a fluoroquinolone), after randomization for a total duration of 7 days (including empiric initial appropriate treatment). Posology and modalities of antibiotic administration will be optimized based on most recent recommendations for ICU patients. Because antibiotic therapy will be variable in the control group, single or double blind is not appropriate. Daily follow-up until death or ICU discharge or day 28 will be performed (vital status, antibiotic therapy, new infection, Clostridium-difficile infection). Clinical (arterial blood gas, temperature, haematology, tracheal secretions) and radiological cure (chest X-ray) will be assessed at Day 7. Systematic MDR bacteria screening will be performed weekly and at ICU discharge. Vital status will be assessed at day 90. Alive patients leaving ICU before 90 days will be contacted by phone (if discharge at home) or by interview at hospital (if transferred in a different ward). Assessment of the clinical and radiological cure by an independent committee (1 specialist in infectious disease and 1 intensivist), blinded of the randomization arm (PROBE methodology).

Conditions

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Ventilator Associated Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicentre randomized non-inferiority trial comparing cotrimoxazole to standard antibiotic therapy for enterobacterial VAP.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cotrimoxazole

Use of cotrimoxazole for enterobacterial VAP. Posology and modalities of antibiotic administration will be optimized based on most recent recommendations for ICU patient. They will receive the treatment for 28 days or until death or until ICU discharge if its before 28days.

Group Type EXPERIMENTAL

cotrimoxazole

Intervention Type DRUG

Use of cotrimoxazole therapy for enterobacterial VAP

standard antibiotic therapy

Use of standard antibiotic therapy enterobacterial VAP. Posology and modalities of antibiotic administration will be optimized based on most recent recommendations for ICU patient. They will receive the treatment for 28 days or until death or until ICU discharge if its before 28days.

Group Type ACTIVE_COMPARATOR

standard antibiotic therapy

Intervention Type DRUG

Use of standard antibiotic therapy for enterobacterial VAP

Interventions

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cotrimoxazole

Use of cotrimoxazole therapy for enterobacterial VAP

Intervention Type DRUG

standard antibiotic therapy

Use of standard antibiotic therapy for enterobacterial VAP

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients hospitalized in an ICU
* Under mechanical ventilation for at least five days
* Microbiologically confirmed VAP preferably on a distal lung sample (bronchoalveolar lavage or protected distal specimen) otherwise endotracheal aspiration
* Enterobacteriaceae susceptible to cotrimoxazole, and for polymicrobial VAP, all bacteria susceptible to cotrimoxazole
* 5\) Treated for at least 24 hours by an appropriate empiric antibiotic therapy (at least one effective antibiotic from the initiation of treatment for this VAP episode), and for polymicrobial VAP, all bacteria susceptible to empiric antibiotic therapy
* Stability of haemodynamic (stability or decrease in catecholamine dose) and respiratory (stability or improvement of FIO2) parameters

Exclusion Criteria

* Haemodynamic instability (increasing dose of a catecholamine in the last 24 hours)
* Contra-indication to cotrimoxazole:

* allergy,
* advanced liver insufficiency,
* renal dysfunction with clearance \<15 mL/min/1.73 m² without hemodialysis
* G6PD deficiency
* history of hypersensitivity to one of the components (in particular, hypersensitivity to sulphonamides
* known macrocytic anemia defined by VGM \>
* treatment with methotrexate
* Infection requiring prolonged antibiotic-therapy (pleural empyema, lung abscess, necrotizing pneumonia, etc…)
* Cystic fibrosis
* Immunosuppression (neutropenia, HIV with CD4 lymphocytes below 200/mm3, immunosuppressive therapy or corticosteroid therapy \>0.5 mg/kg/j before ICU admission)
* Cardiac arrest without awakening
* Moribund state (patient likely to die within 24h)
* Limitation of life support (comfort care applied only) at the time of screening
* Enrolment to another interventional study on VAP care/management
* Pregnancy or breastfeeding
* Subject deprived of freedom, subject under a legal protective measure
* No affiliation to any health insurance system
* Refusal to participate to the study (patient or legal representative or family member or close relative if present)
* Patients previously included in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Médecine Intensive Réanimation - Centre Hospitalier Universitaire Amiens-Picardie

Amiens, , France

Site Status ACTIVE_NOT_RECRUITING

Médecine Intensive Réanimation - Centre Hospitalier Universitaire Angers

Angers, , France

Site Status ACTIVE_NOT_RECRUITING

Médecine Intensive Réanimation - Centre Hospitalier Béthune - Beuvry

Béthune, , France

Site Status ACTIVE_NOT_RECRUITING

Réanimation Médico-chirurgicale - Hôpital Avicenne

Bobigny, , France

Site Status NOT_YET_RECRUITING

Médecine Intensive Réanimation - CHU Bordeaux - Hôpital Pellegrin

Bordeaux, , France

Site Status ACTIVE_NOT_RECRUITING

Réanimation Médico-chirurgicale - Hôpital Ambroise-Paré

Boulogne-Billancourt, , France

Site Status ACTIVE_NOT_RECRUITING

Réanimation polyvalente et Unité de surveillance continue - Centre Hospitalier de Cholet

Cholet, , France

Site Status ACTIVE_NOT_RECRUITING

Réanimation Médicale - Centre Jean Perrin - Site Gabriel Montpied

Clermont-Ferrand, , France

Site Status ACTIVE_NOT_RECRUITING

Médecine Intensive Réanimation - Hôpital Louis Mourier

Colombes, , France

Site Status ACTIVE_NOT_RECRUITING

Réanimation polyvalente et surveillance continus - Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status ACTIVE_NOT_RECRUITING

Médecine Intensive Réanimation - Hôpital François Mitterrand

Dijon, , France

Site Status ACTIVE_NOT_RECRUITING

Réanimation Polyvalente - Centre Hospitalier Annecy Genevois

Épagny, , France

Site Status NOT_YET_RECRUITING

Médecine Intensive Réanimation - Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, , France

Site Status ACTIVE_NOT_RECRUITING

Médecine Intensive Réanimation - Hôpital Michallon

La Tronche, , France

Site Status ACTIVE_NOT_RECRUITING

Réanimation Médicale - Hôpital Robert Salengro

Lille, , France

Site Status NOT_YET_RECRUITING

Réanimation médicale - Centre Hospitalier de Longjumeau

Longjumeau, , France

Site Status ACTIVE_NOT_RECRUITING

Réanimation et Surveillance continue - Centre Hospitalier de Melun

Melun, , France

Site Status ACTIVE_NOT_RECRUITING

Médecine Intensive Réanimation - CHRU de Nancy - Hôpitaux de Brabois

Nancy, , France

Site Status ACTIVE_NOT_RECRUITING

Réanimation Médicale et Maladies Infectieuses - Hôpital Laennec

Nantes, , France

Site Status NOT_YET_RECRUITING

Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière

Paris, , France

Site Status ACTIVE_NOT_RECRUITING

Réanimation Médicale - Hôpital de la Pitié Salpêtrière

Paris, , France

Site Status RECRUITING

Réanimation Médicale - Hôpital Européen Georges Pompidou

Paris, , France

Site Status RECRUITING

Centre Hospitalier Intercommunal Saint-Germain-en-Laye

Poissy, , France

Site Status ACTIVE_NOT_RECRUITING

Médecine Intensive Réanimation - Hôpital René Dubos

Pontoise, , France

Site Status ACTIVE_NOT_RECRUITING

Médecine Intensive Réanimation - Centre Hospitalier Léon Binet

Provins, , France

Site Status NOT_YET_RECRUITING

Médecin Intensive Réanimation - Hôpital Delafontaine

Saint-Denis, , France

Site Status NOT_YET_RECRUITING

Réanimation Polyvalente - Centre Hospitalier Universitaire Nord Saint-Etienne

Saint-Priest-en-Jarez, , France

Site Status ACTIVE_NOT_RECRUITING

Médecine Intensive Réanimation - Nouvel Hôpital Civil

Strasbourg, , France

Site Status ACTIVE_NOT_RECRUITING

Réanimation Polyvalente - Hôpital Sainte Musse

Toulon, , France

Site Status ACTIVE_NOT_RECRUITING

Médecine Intensive Réanimation - Hôpital Bretonneau

Tours, , France

Site Status ACTIVE_NOT_RECRUITING

Countries

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France

Central Contacts

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Damien Roux, MD-PhD

Role: CONTACT

[email protected]
01.47.60.63.29

Aline DECHANET

Role: CONTACT

[email protected]
01.40.25.78.30

Facility Contacts

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Stéphane GAUDRY

Role: primary

[email protected]
01 48 95 55 55

Noémie ZUCMAN

Role: primary

[email protected]

Saad NSEIR

Role: primary

[email protected]
03 20 44 40 84

Karim LAKHAL

Role: primary

[email protected]
02 53 48 27 85

Charles Edouard LUYT

Role: primary

[email protected]
01 42 16 38 24

Jean-Luc DIEHL

Role: primary

[email protected]
01 56 09 32 01

Mohamed FEJJAL

Role: primary

[email protected]
01 64 60 47 42

Daniel DA SILVA

Role: primary

[email protected]
01 42 35 61 40

Other Identifiers

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APHP220799

Identifier Type: -

Identifier Source: org_study_id

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