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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

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 of Ventilator-Associated Pneumonia in Intensive Care Unit (NCT05696093) is a Phase 3 interventional studying Ventilator Associated Pneumonia, sponsored by Assistance Publique - Hôpitaux de Paris. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Ventilator Associated Pneumonia, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 628 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

cotrimoxazole

Use of cotrimoxazole therapy for enterobacterial VAP

DRUG

standard antibiotic therapy

Use of standard antibiotic therapy for enterobacterial VAP

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Médecine Intensive Réanimation - Centre Hospitalier Universitaire Amiens-Picardie
Amiens, France
Médecine Intensive Réanimation - Centre Hospitalier Universitaire Angers
Angers, France
Médecine Intensive Réanimation - Centre Hospitalier Béthune - Beuvry
Béthune, France
Réanimation Médico-chirurgicale - Hôpital Avicenne
Bobigny, France
Médecine Intensive Réanimation - CHU Bordeaux - Hôpital Pellegrin
Bordeaux, France
Réanimation Médico-chirurgicale - Hôpital Ambroise-Paré
Boulogne-Billancourt, France
Réanimation polyvalente et Unité de surveillance continue - Centre Hospitalier de Cholet
Cholet, France
Réanimation Médicale - Centre Jean Perrin - Site Gabriel Montpied
Clermont-Ferrand, France
Médecine Intensive Réanimation - Hôpital Louis Mourier
Colombes, France
Réanimation polyvalente et surveillance continus - Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
Médecine Intensive Réanimation - Hôpital François Mitterrand
Dijon, France
Réanimation Polyvalente - Centre Hospitalier Annecy Genevois
Épagny, France
Médecine Intensive Réanimation - Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, France
Médecine Intensive Réanimation - Hôpital Michallon
La Tronche, France
Réanimation Médicale - Hôpital Robert Salengro
Lille, France
Réanimation médicale - Centre Hospitalier de Longjumeau
Longjumeau, France
Réanimation et Surveillance continue - Centre Hospitalier de Melun
Melun, France
Médecine Intensive Réanimation - CHRU de Nancy - Hôpitaux de Brabois
Nancy, France
Réanimation Médicale et Maladies Infectieuses - Hôpital Laennec
Nantes, France
Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière
Paris, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05696093), the sponsor (Assistance Publique - Hôpitaux de Paris), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05696093 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05696093?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05696093?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05696093. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05696093. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.