Overview
Sponsor-declared trial summary
Acute infection
To assess the effects of N-acetylcysteine on mortality and hospital length of stay in adults admitted to the emergency department with acute infection or sepsis and evidence of liver dysfunction.
Key facts
- Sponsor
- Region Hovedstaden
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2026-05-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2026-525895-25-00
- WHO UTN
- U1111-1336-2257
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the effects of N-acetylcysteine on mortality and hospital length of stay in adults admitted to the emergency department with acute infection or sepsis and evidence of liver dysfunction.
Conditions and MedDRA coding
Acute infection
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age ≥18 years
- Documented clinical suspicion of infection
- Model for end-stage liver disease (MELD) score ≥9
Exclusion criteria 13
- Admitted to hospital >24 hours before randomization
- Inability to read and understand Danish to a degree that allows valid informed consent and completion of trial assessments
- Involuntary admission under the psychiatric law
- Any other condition deemed by the investigator to compromise patient safety or trial integrity (e.g., severe coagulopathy, uncontrolled bleeding, diabetic ketoacidosis)
- Expected initiation of palliative care within 48 hours of randomization
- Ongoing treatment with nitroglycerin
- Any previous severe anaphylaxis
- Known allergy to N-acetylcysteine
- Ongoing treatment with N-acetylcysteine at randomization
- Documented clinical suspicion of bile duct obstruction
- Refractory circulatory shock
- Inability to provide informed consent
- Pregnancy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Days alive and out of hospital from randomization to day 14
Secondary endpoints 7
- Number of participants with one or more serious adverse event within 14 days of randomization
- All-cause mortality at day 180
- Health-related quality of life (HRQoL) at day 180 using EQ-5D-5L index values
- Admission to an intensive care unit (ICU) within 14 days of admission
- Duration of antibiotic therapy from randomization to day 14
- Time to clinical stability
- Days alive and out of hospital from randomization to day 180
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB05229MIG · Substance
- Active substance
- Acetylcysteine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg/kg milligram(s)/kilogram
- Max total dose
- 200 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 500 ml millilitre(s)
- Max total dose
- 500 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Hovedstaden
- Sponsor organisation
- Region Hovedstaden
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Region Hovedstaden
- Contact name
- Theis Skovsgaard Itenov
Public contact point
- Organisation
- Region Hovedstaden
- Contact name
- Theis Skovsgaard Itenov
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Region Hovedstaden ORG-100003705
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 360 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2026-525895-25-00 | 3 |
| Protocol (for publication) | D4_Patient facing documents EQ-5D-5L | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF participant | 1 |
| Subject information and informed consent form (for publication) | L1_ICF ret til ikke-viden | 1 |
| Subject information and informed consent form (for publication) | L1_SIS participant | 2.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Acetylcysteine | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-16 | Denmark | Acceptable 2026-05-21
|
2026-05-22 |