Ventilator Associated PneumoniaPhase 3COTRIVAPNCT05696093
Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit
A Phase 3 study testing cotrimoxazole and standard antibiotic therapy in people with Ventilator Associated Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 30 sites in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- cotrimoxazole and standard antibiotic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- 30 sitesFrance
- Study dates
- 19 Oct 2023to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
France30 sites, 8 recruiting
- Active, not recruiting
Médecine Intensive Réanimation - Centre Hospitalier Universitaire Amiens-Picardie
Amiens, 80054
- Active, not recruiting
Médecine Intensive Réanimation - Centre Hospitalier Universitaire Angers
Angers, 49100
- Active, not recruiting
Médecine Intensive Réanimation - Centre Hospitalier Béthune - Beuvry
Béthune, 62660
- Not yet recruiting
Réanimation Médico-chirurgicale - Hôpital Avicenne
Bobigny, 93000
Stéphane GAUDRY, 01 48 95 55 55, stephane.gaudry@aphp.fr
Stéphane GAUDRY
- Active, not recruiting
Médecine Intensive Réanimation - CHU Bordeaux - Hôpital Pellegrin
Bordeaux, 33000
- Active, not recruiting
Réanimation Médico-chirurgicale - Hôpital Ambroise-Paré
Boulogne-Billancourt, 92100
- Active, not recruiting
Réanimation polyvalente et Unité de surveillance continue - Centre Hospitalier de Cholet
Cholet, 49300
- Active, not recruiting
Réanimation Médicale - Centre Jean Perrin - Site Gabriel Montpied
Clermont-Ferrand, 63003
- Active, not recruiting
Médecine Intensive Réanimation - Hôpital Louis Mourier
Colombes, 92700
- Active, not recruiting
Réanimation polyvalente et surveillance continus - Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100
- Active, not recruiting
Médecine Intensive Réanimation - Hôpital François Mitterrand
Dijon, 21079
- Not yet recruiting
Réanimation Polyvalente - Centre Hospitalier Annecy Genevois
Épagny, 74370
Noémie ZUCMAN, nzucman@ch-annecygenevois.fr
Noémie ZUCMAN
- Active, not recruiting
Médecine Intensive Réanimation - Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85000
- Active, not recruiting
Médecine Intensive Réanimation - Hôpital Michallon
La Tronche, 38700
- Not yet recruiting
Réanimation Médicale - Hôpital Robert Salengro
Lille, 59037
Saad NSEIR, 03 20 44 40 84, saad.nseir@chru-lille.fr
Saad NSEIR
- Active, not recruiting
Réanimation médicale - Centre Hospitalier de Longjumeau
Longjumeau, 91160
- Active, not recruiting
Réanimation et Surveillance continue - Centre Hospitalier de Melun
Melun, 77000
- Active, not recruiting
Médecine Intensive Réanimation - CHRU de Nancy - Hôpitaux de Brabois
Nancy, 54000
- Not yet recruiting
Réanimation Médicale et Maladies Infectieuses - Hôpital Laennec
Nantes, 44093
Karim LAKHAL, 02 53 48 27 85, karim.lakhal@chu-nantes.fr
Karim LAKHAL
- Active, not recruiting
Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière
Paris, 75013
- Recruiting
Réanimation Médicale - Hôpital de la Pitié Salpêtrière
Paris, 75013
Charles Edouard LUYT, 01 42 16 38 24, charles-edouard.luyt@aphp.fr
Charles Edouard LUYT
- Recruiting
Réanimation Médicale - Hôpital Européen Georges Pompidou
Paris, 75015
Jean-Luc DIEHL, 01 56 09 32 01, jean-luc.diehl@aphp.fr
Jean-Luc DIEHL
- Active, not recruiting
Centre Hospitalier Intercommunal Saint-Germain-en-Laye
Poissy, 78003
- Active, not recruiting
Médecine Intensive Réanimation - Hôpital René Dubos
Pontoise, 93500
- Not yet recruiting
Médecine Intensive Réanimation - Centre Hospitalier Léon Binet
Provins, 77160
Mohamed FEJJAL, 01 64 60 47 42, mfejjal@ch-provins.fr
Mohamed FEJJAL
- Not yet recruiting
Médecin Intensive Réanimation - Hôpital Delafontaine
Saint-Denis, 93200
Daniel DA SILVA, 01 42 35 61 40, daniel.silva@ch-stdenis.fr
Daniel DA SILVA
- Active, not recruiting
Réanimation Polyvalente - Centre Hospitalier Universitaire Nord Saint-Etienne
Saint-Priest-en-Jarez, 42270
- Active, not recruiting
Médecine Intensive Réanimation - Nouvel Hôpital Civil
Strasbourg, 67091
- Active, not recruiting
Réanimation Polyvalente - Hôpital Sainte Musse
Toulon, 83056
- Active, not recruiting
Médecine Intensive Réanimation - Hôpital Bretonneau
Tours, 37000
About this study
Official title: Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit. Multicentric Non-inferiority Randomised Controlled Trial
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
Read the detailed description
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
- Ventilator Associated Pneumonia
- Being tested
- cotrimoxazole, standard antibiotic therapy
- Keywords
- intensive care unit, de-escalation, cotrimoxazole, Ventilator Associated Pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cotrimoxazoleDrug
Use of cotrimoxazole therapy for enterobacterial VAP
standard antibiotic therapyDrug
Use of standard antibiotic therapy for enterobacterial VAP
| Study group | Role | What they receive |
|---|---|---|
| cotrimoxazole | Experimental | 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. Receives: Drug: cotrimoxazole |
| standard antibiotic therapy | Active comparator | 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. Receives: Drug: standard antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that cotrimoxazole is non-inferior to best standard of care for the treatment of VAP in ICU in term of survival at day 28
Vital status at day 28
Measured: 28 days after inclusion
Secondary outcomes (11)
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in term of mortality at day 90
Vital status at day 90
Measured: 90 days after inclusion
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in IC in terms of mechanical ventilation (MV)-free-days at day 28
number of MV-free-days through day 28
Measured: 28 days after inclusion
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in terms of rate of cure between days 7 and 10
Clinical, biological and radiological cure evaluated 7 to 10 days after VAP diagnosis, defined as the combination of resolution of signs and symptoms present at enrolment, biological improvement, and improvement or lack of progression of radiological signs, as adjudicated by an independent committee (PROBE methodology)
Measured: days 7 and 10 after inclusion
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in terms of VAP recurrence
new episode of VAP with the same Enterobacteriaceae
Measured: 28 days after inclusion
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in terms of ICU length of stay
ICU length of stay
Measured: 28 days after inclusion
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in terms of hospital length of stay
hospital length of stay
Measured: 28 days after inclusion
To assess the safety of cotrimoxazole compared to best standard of care at day 28 in terms of allergy to antibiotics
safety (rate of allergy due to antimicrobial drug)
Measured: 28 days after inclusion
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in terms of mortality at day 28
Vital status at day 28
Measured: 28 days after inclusion
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in terms of overall antibiotic consumption
antibiotic-free days at day 28
Measured: day 28 after inclusion
To assess the ecological impact of the treatment in terms of acquisition of MDR bacteria in ICU
evolution of rate of MDR bacterial colonization on systematic screening at enrolment until ICU discharge
Measured: 28 days after inclsuion
To assess the ecological impact of the treatment in terms of rate of Clostridioides difficile infection
diagnostic of Clostridioides difficile infection between inclusion and day 28
Measured: 28 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start19 Oct 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre randomized non-inferiority trial comparing cotrimoxazole to standard antibiotic therapy for enterobacterial VAP.
- Masking
- None (open label)
- Enrolment
- 628 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696093
- Sponsor's protocol ID
- APHP220799
- Acronym
- COTRIVAP
- Status last verified
- May 2025
- First submitted
- 21 Nov 2022
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit. Multicentric Non-inferiority Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05696093
- Acronym / sponsor ID
- COTRIVAP / APHP220799
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- intensive care unit, de-escalation, cotrimoxazole, Ventilator Associated Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 628 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre randomized non-inferiority trial comparing cotrimoxazole to standard antibiotic therapy for enterobacterial VAP.
| Arm | Type | Receives |
|---|---|---|
| cotrimoxazole | Experimental | Drug: cotrimoxazoleUse 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. |
| standard antibiotic therapy | Active comparator | Drug: standard antibiotic therapyUse 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- Haemodynamic instability (increasing dose of a catecholamine in the last 24 hours)
- Contra-indication to cotrimoxazole:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cotrimoxazoleUse of cotrimoxazole therapy for enterobacterial VAP | Drug | cotrimoxazole |
| standard antibiotic therapyUse of standard antibiotic therapy for enterobacterial VAP | Drug | standard antibiotic therapy |
Primary outcome
To demonstrate that cotrimoxazole is non-inferior to best standard of care for the treatment of VAP in ICU in term of survival at day 28
Time frame: 28 days after inclusion
Vital status at day 28
11 secondary outcomes
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in term of mortality at day 90
Time frame: 90 days after inclusion
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in IC in terms of mechanical ventilation (MV)-free-days at day 28
Time frame: 28 days after inclusion
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in terms of rate of cure between days 7 and 10
Time frame: days 7 and 10 after inclusion
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in terms of VAP recurrence
Time frame: 28 days after inclusion
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in terms of ICU length of stay
Time frame: 28 days after inclusion
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in terms of hospital length of stay
Time frame: 28 days after inclusion
To assess the safety of cotrimoxazole compared to best standard of care at day 28 in terms of allergy to antibiotics
Time frame: 28 days after inclusion
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in terms of mortality at day 28
Time frame: 28 days after inclusion
To demonstrate that cotrimoxazole is superior to best standard of care for the treatment of VAP in ICU in terms of overall antibiotic consumption
Time frame: day 28 after inclusion
To assess the ecological impact of the treatment in terms of acquisition of MDR bacteria in ICU
Time frame: 28 days after inclsuion
To assess the ecological impact of the treatment in terms of rate of Clostridioides difficile infection
Time frame: 28 days after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cotrimoxazole and standard antibiotic therapy in people with Ventilator Associated Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 30 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damien Roux, MD-PhD (01.47.60.63.29, damien.roux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate that cotrimoxazole is non-inferior to best standard of care for the treatment of VAP in ICU in term of survival at day 28 (time frame: 28 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.