Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
400
Countries
1
Sites
10
respiratory arrest
To compare the effect of phosphocreatine (PCr) (experimental group), versus placebo (saline solution-control group) on the number of days alive and out of hospital at 30 days. (DAOH30).
Key facts
- Sponsor
- Ospedale San Raffaele S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2024-11-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518474-14-00
- EudraCT number
- 2022-003703-16
- ClinicalTrials.gov
- NCT06503016
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To compare the effect of phosphocreatine (PCr) (experimental group), versus placebo (saline solution-control group) on the number of days alive and out of
hospital at 30 days. (DAOH30).
Secondary objectives 1
- Superiority of phosphocreatine (PCr) compared to placebo, in patients reviewed and treated by (MET) in general wards on cognitive function at 30 days
Conditions and MedDRA coding
respiratory arrest
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Admitted in hospital (but outside ICU)
- Age>=18 years
- 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.
- Serum creatinine <=2 mg/dl
- 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 13
- Age < 18 years
- Ongoing cardiac massage
- Current hospital admission from a care nursing facility
- Planned discharge to a care nursing facility
- Reasons for withdrawal of life-sustaining therapy
- History of kidney transplantation
- Solitary kidney (by any reason)
- Serum Creatinine > 2 mg/dl
- Immediate need for ICU admission
- Known allergy to PCr
- Pregnancy
- Previous enrollment and randomization into this trial
- Administration of PCr in the previous 30 day
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Neoton Phlebo 1 g prášek pro infuzní roztok
PRD5429577 · Product
- Active substance
- Phosphocreatine Sodium
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 8.00 g gram(s)
- Max total dose
- 16.00 g gram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01EB06 — FOSFOCREATINE
- Marketing authorisation
- 41/153/91-C/C
- MA holder
- ALFASIGMA S.P.A.
- MA country
- Czech Republic
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Sodio cloruro Fresenius Kabi Italia 0,9%, soluzione per infusione
PRD2128308 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 400.00 ml millilitre(s)
- Max total dose
- 1.20 l litre(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- 031938412
- MA holder
- FRESENIUS KABI ITALIA S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ospedale San Raffaele S.r.l.
- Sponsor organisation
- Ospedale San Raffaele S.r.l.
- Address
- Via Olgettina 60
- City
- Milan
- Postcode
- 20132
- Country
- Italy
Scientific contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Silvia Ajello
Public contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Silvia Ajello
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 350 | 10 |
| Rest of world
Kazakhstan
|
— | 50 | — |
Investigational sites
Azienda Ospedaliero Universitaria Pisana
Anaesthesia and Critical Care Medicine, Via Paradisa 2, 56124, Pisa
Azienda Ospedaliera Regionale San Carlo
Cardiovascular Anaesthesia and ICU, Via Potito Petrone, 85100, Potenza
Azienda Ospedaliera di Padova
Anesthesia and Intensive Care, Via Jacopo Facciolati 71, 35127, Padova
Azienda Unita Sanitaria Locale Della Romagna
Emergency Room - Emergency Medicine, Viale Stradone 9, 48018, Faenza
Ospedale Cardinal Massaia
Anesthesia and Intensive Care, Corso Dante Alighieri 202, 14100, Asti
Azienda Sanitaria Universitaria Friuli Centrale
Anesthesia and Intensive Care, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Ospedale San Raffaele S.r.l.
Anesthesia and Intesive care unit, Via Olgettina 60, 20132, Milan
Azienda Unita Sanitaria Locale Della Romagna
Anesthesia and Intensive Care, Via Alcide De Gasperi 8, 48121, Ravenna
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Anesthesia and Intensive Care, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliera-Universitaria Di Cosenza
Anesthesia and Intensive Care, Via Felice Migliori 1, 87100, Cosenza
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518474-14-00_for publication | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_for publication | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF legal guardian_for publication | 2.1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_GP letter_for publication | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_patient card_for publication | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_privacy policy adults_for publication | 2.1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_privacy policy legal guardian_for publication | 2.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Neoton Phlebo | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT 2024-518474-14-00_for publication | 2.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-15 | Italy | Acceptable 2024-11-11
|
2024-11-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-01 | |||
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-11 | Italy | Acceptable | 2025-10-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-19 | Italy | Acceptable | 2026-04-22 |