Phase 3 Sickle Cell Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 years or older
• People who have been diagnosed with sickle cell disease with one of these specific genetic types: SS, SC, Sβ, or Sβ+
• People who have been admitted to an Intensive Care Unit primarily because of a sickle cell pain crisis (sudden severe pain affecting areas such as the limbs, ribs, chest, head, spine, or pelvis that has no other explanation) and/or a lung complication called Acute Chest Syndrome (a combination of breathing difficulties, chest pain, or abnormal sounds in the lungs, along with new changes visible on a chest X-ray, CT scan, or ultrasound)
• People who have been receiving morphine or oxycodone given through a drip or injection, started less than 72 hours before joining the trial
• People (or their next of kin) who have been informed about the study and have agreed to take part — in emergencies where the patient cannot consent and no family member can be reached, an ICU doctor may enrol the patient under French emergency research law
• French-speaking people
• People who have French health insurance coverage

Who may not be able to join:

• People who are pregnant or currently breastfeeding — women who could become pregnant will be tested before enrolment is confirmed
• People who are under a legal guardianship or court-ordered protection arrangement
• People who are in prison or involuntarily held in a facility
• People admitted to the ICU primarily for a sickle cell complication other than a pain crisis or Acute Chest Syndrome (for example, priapism, stroke, spleen or liver complications, or bone marrow problems)
• People who are already wearing a lidocaine medicated skin patch at the time of screening
• People with a known or suspected allergy to lidocaine, or to similar local anaesthetic medicines (such as bupivacaine or ropivacaine), or to any ingredient in the study medication
• People currently taking certain heart rhythm medicines known to cause a specific dangerous heart rhythm abnormality called torsade de pointe
• People taking regular or occasional medicines that interact with specific liver enzymes known as CYP3A or CYP1A2 (confirm with trial site)
• People who have a condition called porphyria — whether currently active, in remission, or carrying the relevant gene mutation without symptoms
• People who have epilepsy
• People who are in a state of shock (very low blood pressure due to low blood volume or other causes) at the time of screening
• People with known heart conduction problems, including atrioventricular block, prolonged QT interval, or heart failure
• People with long-term severe breathing problems who require home non-invasive ventilation (other than CPAP) or permanent home oxygen therapy
• People who meet the 2012 Berlin medical definition of Acute Respiratory Distress Syndrome
• People with significant liver disease, measured using a scoring system called MELD above 19 (confirm with trial site)
• People with significant kidney disease where kidney filtration is below 30 mL/min/m² (confirm with trial site)
• People whose body weight is below 40 kg or above 120 kg
• People who have already taken part in this trial within the past 3 months
• People who are currently on invasive mechanical ventilation (breathing through a machine via a tube)
• People with a reduced level of consciousness, measured as below 13 on the Glasgow Coma Scale (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.