Combined mPCR and algorithm-based therapy to optimize early antibiotics in VAP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, parallel-group randomized trial compares a strategy that uses rapid respiratory mPCR plus an algorithm-based therapy, informed by local epidemiology, to conventional care for initial antibiotic choices in adults with VAP. Both groups collect deep respiratory samples before enrolling and start antibiotics by clinician discretion based on standard practices. The intervention arm receives mPCR results within roughly 12 hours of sampling, and clinicians adjust therapy according to the algorithm to optimize early treatment. Conventional care relies on standard culture results and clinician judgment without the mPCR-guided algorithm. The primary endpoint is the proportion of patients with optimized antibiotic therapy within 24 hours of sampling.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults (≥18 years) with VAP (mechanical ventilation and hospitalization ≥ 48 hours) and deep respiratory sample by mini BAL \< 12 hours. The diagnosis of pneumonia includes two clinical criteria among fever (≥38.3°C), purulent sputum or aspiration, hyperleukocytosis (\>12,000 WBC/mm³) or leukopenia (\<4,000 WBC/mm³), hypoxemia, auscultatory signs in the affected area, and a newly-appeared parenchymal infiltrate
* Patient receiving initial probabilistic antibiotic therapy for VAP suspicion
* Informed consent or emergency procedure
* Patient affiliated with or beneficiary of a health insurance plan.

Non inclusion Criteria:

* Pregnancy
* Congenital immunodeficiency;
* HIV infection with the lymphocyte CD4 count below 200/mm3 or unknown in the last year;
* Acute hematologic malignancy;
* Neutropenia (\<1 leucocyte/mL or \< 0.5 neutrophil/mL);
* Immunosuppressive drugs within the previous 30 days, including anti-cancer - Chemotherapy and anti-rejection drugs for organ/bone marrow transplant
* Corticosteroids ≥ 20 mg/d of prednisone equivalent for more than 14 days
* Known allergy to beta-lactams
* Moribund patient or death expected from underlying disease during the current admission;
* Patient deprived of liberty or under legal protection measure;
* Participation in another interventional trial.

Exclusion criteria :

* mPCR non available

Where it's running

• Ch Ales
  Alès, France Recruiting
• CHU Nîmes
  Nîmes, France Recruiting

Study contacts

• Study coordinator: Hugo MARTINIERE, PH
• Email: hugo.martiniere@chu-nimes.fr
• Phone: +33 4 66 68 33 31

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Innate Immune Immunoparalysis and Ventilator-Associated Pneumonia in Critically Ill Elderly Patients

  This study tests whether signs of innate immune immunoparalysis in adults on ventilators are linked to developing ventilator-associated pneumonia (VAP).

  Recruiting Hospital Universitari de Bellvitge · L'Hospitalet de Llobregat, Barcelona · NCT07551258

• Using airway resistance changes to guide suctioning for ventilated patients

  This study will test whether monitoring airway viscous resistance from ventilator waveforms can help time sputum suctioning for patients on mechanical ventilation with ARDS, AECOPD, or severe pneumonia.

  Recruiting at 3 sites Affiliated Hospital of Nantong University · Bengbu, Anhui and 2 other locations · NCT07375667

• Two Oral Care Methods for Mechanically Ventilated Adults

  This trial tests whether a pediatric toothbrush or a foam swab for oral care affects oral bacteria and the risk of ventilator-associated pneumonia in adults on mechanical ventilation.

  Recruiting Marmara University · Zonguldak · NCT07283380

• Aztreonam‑avibactam for MBL-producing CRE infections in hospitalized adults

  This study will see if aztreonam‑avibactam helps hospitalized adults with complicated intra‑abdominal infections or hospital/ventilator‑associated pneumonia caused by MBL-producing CRE.

  Recruiting Sir Run Run Shaw Hospital · Nanchang, Jiangxi and 1 other locations · NCT07268560

• Early detection of ventilator-associated pneumonia in critically ill children using microbial and immune signatures.

  This project will test whether combining microbial genomic data and a child's immune-response signals can detect ventilator-associated pneumonia earlier in critically ill children on mechanical ventilation.

  Recruiting University of Cambridge · Cambridge · NCT07026656

• Inhaled colistin to prevent pneumonia in ventilated patients

  This study is testing if inhaled colistin can help prevent pneumonia in patients on ventilators who are at high risk for infections.

  Recruiting Qilu Hospital of Shandong University · Jinan, Shandong · NCT06834971

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.