Using Pirfenidone to prevent lung fibrosis in ARDS patients

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 clinical trial evaluates the efficacy of Pirfenidone, an antifibrotic drug, in patients with Acute Respiratory Distress Syndrome (ARDS). The study aims to determine if Pirfenidone can reduce the development of pulmonary fibrosis, a common complication following ARDS. Participants will be randomly assigned to receive either Pirfenidone or a placebo while being monitored for improvements in lung function and overall recovery. The trial focuses on patients who meet specific criteria for ARDS and have inflammatory characteristics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Concomitant presence of:

* ARDS (moderate and severe) - Berlin definition

  1. Within 1 week of a known clinical insult or new or worsening respiratory symptoms
  2. Bilateral opacities on CXR which are not fully explained by effusions, lobar/lung collapse or nodules
  3. Respiratory failure not fully explained by cardiac failure or fluid overload
  4. PaO2/FiO2\<200 mmHg with PEEP\<=5 cmH2O (invasive mechanical ventilation)
* Inflammatory ARDS phenotype (28), defined by at least one of the following:

  1. High plasma levels of inflammatory biomarkers
  2. Vasopressor dependence
  3. Lower serum bicarbonate or increased serum lactate
* Informed consent expressed by the patient or by legal representative or on the Ethical Committee indication.
* Age \>=18 years

Exclusion Criteria:

* Intubated and mechanically ventilated via an endotracheal or tracheostomy tube (\>7 days) up to the time of randomization
* ARDS severe or moderate for more than 36 hours
* Untreated pulmonary embolism, pleural effusion or pneumothorax as the primary cause of ARF
* ARF fully explained by left ventricular failure or fluid overload
* Consent declined
* Severe chronic respiratory disease requiring domiciliary ventilation
* Clinical suspicion for significant restrictive lung disease
* Pregnant women or women of childbearing potential who are sexually active
* Known allergy to pirfenidone
* Concomitant use of fluvoxamine
* Known severe hepatic failure
* Known severe renal failure or necessity of dialysis not related to acute disease
* Little chance of survival (SAPS II score\>75)

Where it's running

• IRCCS San Raffaele Scientific Institute
  Milan, Mi, Italy Recruiting
• Ospedale Cesare Arrigo
  Alessandria, Piedmont, Italy Recruiting
• Ospedale Santa Maria
  Bari, Italy Recruiting
• ASST Spedali Civili di Brescia
  Brescia, Italy Recruiting
• Ospedale San Giovanni di Dio - Azienda Ospedaliera Universitaria di Cagliari
  Cagliari, Italy Recruiting
• Ospedale di Merano
  Merano, Italy Recruiting

Study contacts

• Study coordinator: Nora Di Tomasso, MD
• Email: ditomasso.nora@hsr.it
• Phone: +39022643

Similar studies

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

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• Sodium bicarbonate with bedside electrical impedance tomography to map lung blood flow in ventilated adults

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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.