Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia

NCT07403474 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025-A02343-46
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the impact of a strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology on the early optimization of initial antibiotic therapy for ventilator-associated pneumonia (VAP) (intervention), compared to a conventional strategy (control). A bicentric, parallel-group, randomized controlled trial. The primary assessment criterion is the proportion of early optimized antibiotic therapy within 24 hours of respiratory sampling.

Conditions

Ventilator Associated Pneumonia ( VAP)

Keywords

mPCR; ventilator associated pneumonia; algorithm-based therapy

Outcome Measures

Primary Outcomes (1)

• The effectiveness of a combined use a broad panel respiratory mPCR and an algorithm-based therapy developed using local epidemiology on the early optimization of initial antibiotic therapy for VAP, as compared to a conventional strategy

  Proportion of patients receiving optimized antibiotic therapy defined as effective antibiotic therapy and for which antibiotic de-escalation, when recommended, was performed early, within 24 hours after deep respiratory sampling.

  Day 1

Secondary Outcomes (11)

• Duration of exposure to broad-spectrum antibiotic therapy.

  Day 28

• Compare expected and actual time frames for optimizing antibiotic therapy in the two arms.

  day 28

• Quantify early antibiotic de-escalation in the two groups under study

  day 1 and day 7

• Rate of Clinical Cure at Day

  day 7

• Mechanical ventilation at day 28

  day 28

Study Arms (2)

combined use of mPCR and algorithm-based therapy

EXPERIMENTAL

strategy combining respiratory mPCR on a deep respiratory sample obtained by mini bronchoalveolar lavage and algorithm-based therapy developed using local epidemiology

Procedure: strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology

Conventional strategy for antibiotic therapy at discretion of ICU physicians

NO INTERVENTION

The conventional strategy is based on the clinician's choice in accordance with best practice recommendations, without the combined use of respiratory mPCR and algorithm-based therapy.

Interventions

strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology PROCEDURE

strategy combining respiratory mPCR carried out either by mini bronchoalveolar lavage (BAL) via bronchoscopy or by blind mini BAL, and algorithm-based therapy developed using local epidemiology for the early optimization of initial antibiotic therapy

combined use of mPCR and algorithm-based therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• mPCR non available

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nîmes

Nîmes, 34070, France

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hugo MARTINIERE, PH

CONTACT

+33 4 66 68 33 31; hugo.martiniere@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors (investigator-delegated evaluators, different from those who performed the procedure) will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This prospective, randomized, controlled, blinded, parallel-group study evaluates a semi-guided antibiotic strategy based on respiratory mPCR integrated with a locally derived decision algorithm, compared with standard antibiotic care in intensive care patients with ventilator-associated or nosocomial pneumonia.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)