A Phase 4 interventional study of N-Acetylcysteine (NAC) Treatment in Sepsis, Acute Infection and Severe Infection, sponsored by Theis S. Itenov. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Theis S. Itenov · Phase 4, Interventional, and Treatment
Among 43 studies in Sepsis with a site in Denmark — 6 open to participants now, 6 under way, 1 of them phase 3. Sepsis · Denmark.
Among the 43 studies in Sepsis with a site in Denmark, this one is the 9th largest by planned enrollment of the 23 interventional ones, is one of 4 that started in 2026, is one of 8 in phase 4, and was the 40th registered.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 360 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →6 of the 43 studies in Sepsis with a site in Denmark are open now, in 12 countries. Each count lists the studies.
Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →43 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 4 started in 2026.
Median enrollment 153 across the 23 interventional studies, 50 across the 18 observational. Of the 29 that completed or were terminated, 2 (7%) have results posted.
6 of 43 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Theis S. Itenov as lead sponsor.
Theis S. Itenov has 1 study filed under Sepsis — fewer than ten, so there is no comparison to draw.
1 of the studies in Sepsis with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07215702AstraZenecaA Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury. | 2027-02-11 |
Among the 43 studies in Sepsis with a site in Denmark, from their registry updates:
The primary objective of the IMPACT-NAC trial is to assess the effects of N-acetylcysteine on survival and hospital length of stay in adults admitted to the emergency department with acute infection or sepsis and evidence of liver dysfunction.
The main question it aims to answer is: does N-acetylcysteine increase the number of days alive and out of the hospital within the first 14 days after enrolment in the trial?
To answer this question, we will conduct a randomized, double-blinded controlled trial of 360 participants.
Participants will be randomized to either N-acetylcysteine or placebo (normal saline without active drugs). This will be administered as an infusion during four hours within the first day of hospital admission.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: N-Acetylcysteine (NAC) Treatment
Intravenous infusion of N-acetylcysteine (200 mg/kg mixed with normal saline to a final volume of 500 ml) administered over four hours.
Days alive and out of hospital at 14 days post-randomization (DAOH-14)
Time frame: Assessed 14 days post-randomization
Number of participants with one or more serious adverse event within 14 days of randomization
Time frame: Assessed 14 days post-randomization
All-cause mortality at day 180
Time frame: Assessed at 180 days post-randomization
Health-related quality of life (HRQoL) at day 180 using EQ-5D-5L
Time frame: Assessed 180 days post-randomization
Admission to an intensive care unit (ICU) within 14 days of admission
Time frame: Assessed at 14 days post-randomization
Duration of antibiotic therapy from randomization to day 14
Time frame: Assessed at 14 days post-randomization
Time to clinical stability
Number of days from randomization to first occurrence of clinical early warning score (C-EWS) ≤1. For participants with registered chronic elevated C-EWS parameters, the adjusted score will be used.
Time frame: Assessed at 14 days post-randomization
Started Sep 2026 (actual). Primary completion is estimated for Feb 2028, 17 months after the start.
Of 65 non-industry phase 4 interventional studies under Sepsis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 45. This study's planned 17 months is below that.
Counting every sponsor, half of 66 studies reached it within 25 months; a quarter within 15 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Acetylcysteine