Clinical trial • Phase III • Neurology|Cardiology|Respiratory
PHOSPHOCREATINE SODIUM for Respiratory arrest|Threatened airway|Tachycardia|Bradypnea|Abnormal pulse rate (<40 or >140 bpm)|Acute decrease in level of consciousness|Tachypnea|Hypotension (systolic blood pressure <90 mmHg)|Decrease in Glasgow Coma Scale >2 points
Phase III trial of PHOSPHOCREATINE SODIUM for Respiratory arrest|Threatened airway|Tachycardia|Bradypnea|Abnormal pulse rate (<40 or >140 bpm)|Acute decre…
Overview
- Trial Therapeutic Area
- Neurology|Cardiology|Respiratory
- Trial Disease
- Respiratory arrest|Threatened airway|Tachycardia|Bradypnea|Abnormal pulse rate (<40 or >140 bpm)|Acute decrease in level of consciousness|Tachypnea|Hypotension (systolic blood pressure <90 mmHg)|Decrease in Glasgow Coma Scale >2 points
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 15-10-2024
- First CTIS Authorization Date
- 18-11-2024
Trial design
Randomised, placebo comparator: sodium chloride 0.9% solution for infusion (sodio cloruro fresenius kabi italia 0,9%, soluzione per infusione) administered as infusion (product record shows max daily 400.00 ml, max total 1.20 l over treatment period). experimental arm: neoton phlebo (phosphocreatine sodium) powder for infusion (neoton phlebo 1 g prášek pro infuzní roztok); product record indicates max daily dose 8 g and max total 16 g; route infusion. exact dosing schedule and start dose not specified in ctis metadata.-controlled Phase III trial across 10 sites in Italy.
- Randomised
- Yes
- Comparator
- Placebo comparator: Sodium chloride 0.9% solution for infusion (Sodio cloruro Fresenius Kabi Italia 0,9%, soluzione per infusione) administered as infusion (product record shows max daily 400.00 ml, max total 1.20 L over treatment period). Experimental arm: Neoton Phlebo (phosphocreatine sodium) powder for infusion (Neoton Phlebo 1 g prášek pro infuzní roztok); product record indicates max daily dose 8 g and max total 16 g; route infusion. Exact dosing schedule and start dose not specified in CTIS metadata.
- Target Sample Size
- 350
- Trial Duration For Participant
- 30
Eligibility
Recruits 350 Vulnerable population flag selected. Written informed consent may be provided by the patient themselves or by the patient's next of kin or legal representative as requested by the ethics committee. Separate subject information and informed consent forms are provided for adults and for legal guardians (documents listed: L1_SIS and ICF adults; L1_SIS and ICF legal guardian), and privacy policy documents for adults and legal guardians are available..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- Vulnerable population flag selected. Written informed consent may be provided by the patient themselves or by the patient's next of kin or legal representative as requested by the ethics committee. Separate subject information and informed consent forms are provided for adults and for legal guardians (documents listed: L1_SIS and ICF adults; L1_SIS and ICF legal guardian), and privacy policy documents for adults and legal guardians are available.
Inclusion criteria
- {"criterion_text":"- Admitted in hospital (but outside ICU)"}
- {"criterion_text":"- Age>=18 years"}
- {"criterion_text":"- Written informed consent from the patient him- /herself or the patient's next of kin or the legal representative as requested by the ethics committee."}
- {"criterion_text":"- Serum creatinine <=2 mg/dl"}
- {"criterion_text":"- Patient with impending or underlying cardiac failure or cardiac arrest, irrespectively of the primitive organ failure, and the Medical Emergency Team (MET) is called upon at least one of the following: a. Threatened airways; b. Respiratory arrest; c. Respiratory rate <5 or >36 breaths per min; d. Pulse rate <40 or >140 beats per min; e. Systolic blood pressure < 90 mm Hg; f. Sudden fall in level of consciousness; g. Fall in Glasgow coma scale of > 2 points."}
Exclusion criteria
- {"criterion_text":"- Age < 18 years"}
- {"criterion_text":"- Known allergy to PCr"}
- {"criterion_text":"- Pregnancy"}
- {"criterion_text":"- Previous enrollment and randomization into this trial"}
- {"criterion_text":"- Administration of PCr in the previous 30 day"}
- {"criterion_text":"- Ongoing cardiac massage"}
- {"criterion_text":"- Current hospital admission from a care nursing facility"}
- {"criterion_text":"- Planned discharge to a care nursing facility"}
- {"criterion_text":"- Reasons for withdrawal of life-sustaining therapy"}
- {"criterion_text":"- History of kidney transplantation"}
- {"criterion_text":"- Solitary kidney (by any reason)"}
- {"criterion_text":"- Serum Creatinine > 2 mg/dl"}
- {"criterion_text":"- Immediate need for ICU admission"}
Endpoints
Primary endpoints
- {"endpoint_text":"- How to calculate DAH30 (days alive and out-of-hospital at day 30): Has patient died in hospital or after discharge on any day within the first 30-days after randomization? If YES we will give 0 points Is the patient discharged from hospital on Day 5 after randomization but is subsequently readmitted for 5-days before their second hospital discharge? If YES we will give 20 points Is patient in a post- discharge nursing facility? If YES: we won’t consider as days at home.","definition_or_measurement_approach":"DAH30 (days alive and out-of-hospital at day 30) calculated as follows: if the patient dies in hospital or after discharge within the first 30 days after randomization => 0 points; example rule: if discharged on day 5 and then readmitted for 5 days before a subsequent discharge => give 20 points; days spent in a post-discharge nursing facility are not counted as days at home."}
Recruitment
- Planned Sample Size
- 350
- Recruitment Window Months
- 31
- Consent Approach
- Written informed consent required from the patient themselves or, if not possible, from the patient's next of kin or legal representative as requested by the ethics committee. Separate ICFs are available for adults and for legal guardians (L1_SIS and ICF adults; L1_SIS and ICF legal guardian). Languages of ICFs not specified in the CTIS metadata.
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 350
Italy
- Earliest CTIS Part Ii Submission Date
- 29-10-2024
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 540
- Number Of Sites
- 10
- Number Of Participants
- 350
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Anesthesia and Intensive Care
- Contact Person Name
- Matteo Filippini
- Contact Person Email
- matteo.filippini123@gmail.com
- Site Name
- Ospedale Cardinal Massaia
- Department Name
- Anesthesia and Intensive Care
- Contact Person Name
- Agostino Roasio
- Contact Person Email
- aroasio@asl.at.it
- Site Name
- Azienda Ospedaliera Regionale San Carlo
- Department Name
- Cardiovascular Anaesthesia and ICU
- Contact Person Name
- Gianluca Paternoster
- Contact Person Email
- gianluca.paternoster@ospedalesancarlo.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- Anesthesia and Intensive Care
- Contact Person Name
- Andrea Portoraro
- Contact Person Email
- andrea.portoraro@auslromagna.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- Anesthesia and Intensive Care
- Contact Person Name
- Nicolò Sella
- Contact Person Email
- n.sella89@gmail.com
- Site Name
- Azienda Ospedaliera-Universitaria Di Cosenza
- Department Name
- Anesthesia and Intensive Care
- Contact Person Name
- Andrea Bruni
- Contact Person Email
- Andrea.bruni@unical.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Anesthesia and Intesive care unit
- Contact Person Name
- Silvia Ajello
- Contact Person Email
- ajello.silvia@hsr.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Anaesthesia and Critical Care Medicine
- Contact Person Name
- Fabio Guarracino
- Contact Person Email
- f.guarracino@ao-pisa.toscana.it
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- Anesthesia and Intensive Care
- Contact Person Name
- Francesco Meroi
- Contact Person Email
- francesco.meroi@asufc.sanita.fvg.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna (Faenza)
- Department Name
- Emergency Room - Emergency Medicine
- Contact Person Name
- Francesco Savelli
- Contact Person Email
- francesco.savelli@auslromagna.it
Sponsor
Primary sponsor
- Full Name
- Ospedale San Raffaele S.r.l.
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Italy
Third parties
- {"country":"Czech Republic","full_name":"ALFASIGMA S.P.A.","duties_or_roles":"Marketing authorisation holder / product supplier for Neoton Phlebo (phosphocreatine sodium)","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"FRESENIUS KABI ITALIA S.R.L.","duties_or_roles":"Manufacturer / supplier of sodium chloride 0.9% infusion (used as placebo control)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Neoton Phlebo 1 g prášek pro infuzní roztok
- Active Substance
- PHOSPHOCREATINE SODIUM
- Modality
- Small molecule
- Routes Of Administration
- Infusion
- Route
- Infusion
- Authorisation Status
- Authorised (marketing authorisation present: 41/153/91-C/C; prodAuthStatus:2)
- Maximum Dose
- Max daily 8 g; max total 16 g (treatment period up to 3 days)
- Investigational Product Name
- Sodio cloruro Fresenius Kabi Italia 0,9%, soluzione per infusione
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- Infusion
- Route
- Infusion
- Authorisation Status
- Authorised (marketing authorisation present: 031938412; prodAuthStatus:2)
- Maximum Dose
- Max daily 400 ml; max total 1.20 L (treatment period up to 3 days)
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