Early-Onset Neonatal SepsisPhase 4DurATi-nNCT05329701
Individualized Duration of Antibiotic Treatment in Early Onset Infection in Newborns.
A Phase 4 study testing Individualized treatment duration strategy in people with Early-Onset Neonatal Sepsis and Antibiotic Side Effect, run by Ulrikka Nygaard at 1 site in Denmark.
Trial summary
A nationwide multicenter open label randomized controlled non-inferiority trial, including 18 departments. The study aims to compare an individualized antibiotic treatment duration with standard seven days of antibiotic treatment for culture negative early-onset infection in term newborns. Read more about this study
- Who is it for?
- Ages 1 hour to 72 hours
- Conditions the study is for
- Early-Onset Neonatal Sepsis, Antibiotic Side Effect
- What is being tested?
- Individualized treatment duration strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Apr 2022to 10 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age ≥ 35 weeks
- Birth weight ≥ 2000
- Probable or possible infection according to the structured infection risk assessment
- Sufficient size blood culture, preferably 0.5-1 ml, but at least 0.2 ml, drawn after onset of symptoms but before start of antibiotic treatment
- Negative blood culture after 48 hours
Who cannot join
- Infants with positive blood culture
- Blood culture volume prior to antibiotics of < 0.2 ml
- Site-specific infection as for example, meningitis or osteomyelitis
- Infant fulfill current recommendation to stop antibiotic treatment at 36-48 hours; Low suspicion of sepsis initially including few and vague symptoms, CRP maximum 35-50 mg/l, negative blood culture and no symptoms after 48 hours of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualized Duration of Antibiotic Treatment in Culture Negative Early Onset Infection in Term Born Newborns: A Nationwide Randomized Controlled Non-inferiority Trial.
A nationwide multicenter open label randomized controlled non-inferiority trial, including 18 departments. The study aims to compare an individualized antibiotic treatment duration with standard seven days of antibiotic treatment for culture negative early-onset infection in term newborns.
Read the detailed description
There is a documented antibiotic overuse in newborns, and a lack of evidence for the optimal duration of antibiotic therapy in culture-negative infection. The study aims to evaluate the effect of individualized treatment duration in early-onset infection.
The study aims to compare an individualized treatment duration with seven days of treatment for culture negative early-onset infection. The investigators hypothesize that the individualized treatment duration, based on structured clinical assessment of symptoms and level of CRP is non-inferior to the standard care being seven days of treatment. In the experimental treatment arm, antibiotics will be stopped when the participant had 24 hours without symptoms and at same time point have decreasing level of CRP, with an absolute threshold of CRP ≤ 30 mg/l. The investigators hypothesize that individualized treatment will shorten the duration of antibiotic therapy in newborns with early onset infection with very little risk of relapse. Newborns who fulfill criteria to stop antibiotics within 48 hours will not be eligible for inclusion.
- Being tested
- Individualized treatment duration strategy
- Keywords
- neonatal, early-onset, infection, antibiotic
- Medical subject headings
- Neonatal Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized treatment duration strategyOther
As listed under arm description.
| Study group | Role | What they receive |
|---|---|---|
| Individualized treatment duration | Experimental | Antibiotic treatment will be discontinued when both of the following two criteria are fulfilled:
1. The infant has had 24 hours without clinical symptoms of infection, after systematic clinical evaluation by a neonatologist. Clinical symptoms specified in Table 1.
2. CRP is < 30 mg/l. If CRP is > 30 at the time when the infant has been symptom-free for 24 hours, CRP will be assessed once every 24 -48 hours and antibiotics will be stopped when CRP < 30. Receives: Other: Individualized treatment duration strategy |
| Standard treatment duration | No intervention | Standard treatment duration is seven days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission due to infection.
Readmission due to infection, defined as symptoms, affected biomarkers and antibiotic treatment > 72 hours
Measured: From 1-21 days after end of first course of antibiotic treatment.
Death
Death of any cause
Measured: From 1-21 days after end of first course of antibiotic treatment.
Total use of antibiotics
Use of antibiotics (in hours)
Measured: From initiation of antibiotics and the next 28 days.
Secondary outcomes (2)
C-reactive protein (CRP)
CRP (mg/l) levels at follow-up
Measured: CRP measured at follow-up 2 days after initial antibiotic treatment ended
Readmission due to infection within 3 months
Readmission due to infection, defined as symptoms, affected biomarkers and antibiotic treatment > 72 hours
Measured: From 1-100 days after first course of antibiotics ended.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start22 Apr 2022
- Primary completion5 Apr 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early-Onset Neonatal SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a nationwide multicenter open label non-inferiority pragmatic randomized controlled trial. Patients will be randomized 1:1 to experimental treatment duration or standard care. Patients will be stratified based on if maximum CRP level is above or below 90 mg/l.
- Masking
- None (open label)
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulrikka Nygaard
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark, University of Copenhagen
- Responsible party
- Sponsor-investigator, Ulrikka Nygaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Emma Malchau Carlsen, MD, PhD, Principal investigator, Department of Neonatology, Rigshospitalet, Copenhagen, DenmarkTine Brink Henriksen, MD, Prof, Study director, Department of Neonatology, Skejby Sygehus, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329701
- Sponsor's protocol ID
- H-21004823
- Acronym
- DurATi-n
- Status last verified
- Jan 2026
- First submitted
- 7 Apr 2022
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers who provide a methodologically sound proposal will be granted access to a full copy of individual deidentified data.
Publications
Carlsen EM, Hansen BM, Dungu KHS, Lindhard MS, Gudiksen A, Aunsholt L, Viuff AC, Zacharaissen G, Greisen G, Lewis A, Holm SK, Dayani G, Pedersen P, Vibede LD, Stanchev H, Jensen KV, Fenger-Gron J, Lund S, Agergaard P, Bender L, Ryttov K, Milovanov V, Skovgaard AL, Vandborg PK, Hedegaard SS, Blanche P, Nygaard U, Henriksen TB. Individualised duration of antibiotic treatment in culture-negative early-onset sepsis in late-preterm and term-born neonates in Denmark (DURATION): a multicentre, open-label, randomised, controlled, non-inferiority trial. Lancet Child Adolesc Health. 2026 Aug;10(8):573-583. doi: 10.1016/S2352-4642(26)00118-5. Epub 2026 Jun 16.
PubMed 42302804
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Duration of Antibiotic Treatment in Culture Negative Early Onset Infection in Term Born Newborns: A Nationwide Randomized Controlled Non-inferiority Trial.
- ClinicalTrials.gov ID
- NCT05329701
- Acronym / sponsor ID
- DurATi-n / H-21004823
- Keywords
- neonatal, early-onset, infection, antibiotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Ulrikka NygaardUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark, University of Copenhagen
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 5 Apr 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A nationwide multicenter open label randomized controlled non-inferiority trial, including 18 departments. The study aims to compare an individualized antibiotic treatment duration with standard seven days of antibiotic treatment for culture negative early-onset infection in term newborns.
Detailed description
There is a documented antibiotic overuse in newborns, and a lack of evidence for the optimal duration of antibiotic therapy in culture-negative infection. The study aims to evaluate the effect of individualized treatment duration in early-onset infection.
The study aims to compare an individualized treatment duration with seven days of treatment for culture negative early-onset infection. The investigators hypothesize that the individualized treatment duration, based on structured clinical assessment of symptoms and level of CRP is non-inferior to the standard care being seven days of treatment. In the experimental treatment arm, antibiotics will be stopped when the participant had 24 hours without symptoms and at same time point have decreasing level of CRP, with an absolute threshold of CRP ≤ 30 mg/l. The investigators hypothesize that individualized treatment will shorten the duration of antibiotic therapy in newborns with early onset infection with very little risk of relapse. Newborns who fulfill criteria to stop antibiotics within 48 hours will not be eligible for inclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a nationwide multicenter open label non-inferiority pragmatic randomized controlled trial. Patients will be randomized 1:1 to experimental treatment duration or standard care. Patients will be stratified based on if maximum CRP level is above or below 90 mg/l.
| Arm | Type | Receives |
|---|---|---|
| Individualized treatment duration | Experimental | Other: Individualized treatment duration strategyAntibiotic treatment will be discontinued when both of the following two criteria are fulfilled: 1. The infant has had 24 hours without clinical symptoms of infection, after systematic clinical evaluation by a neonatologist. Clinical symptoms specified in Table 1. 2. CRP is < 30 mg/l. If CRP is > 30 at the time when the infant has been symptom-free for 24 hours, CRP will be assessed once every 24 -48 hours and antibiotics will be stopped when CRP < 30. |
| Standard treatment duration | No intervention | –Standard treatment duration is seven days. |
Who may qualify
- Ages
- 1 hour to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gestational age ≥ 35 weeks
- Birth weight ≥ 2000
- Probable or possible infection according to the structured infection risk assessment
- Sufficient size blood culture, preferably 0.5-1 ml, but at least 0.2 ml, drawn after onset of symptoms but before start of antibiotic treatment
- Negative blood culture after 48 hours
Key exclusion criteria (4 listed)
- Infants with positive blood culture
- Blood culture volume prior to antibiotics of < 0.2 ml
- Site-specific infection as for example, meningitis or osteomyelitis
- Infant fulfill current recommendation to stop antibiotic treatment at 36-48 hours; Low suspicion of sepsis initially including few and vague symptoms, CRP maximum 35-50 mg/l, negative blood culture and no symptoms after 48 hours of treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized treatment duration strategyAs listed under arm description. | Other | Individualized treatment duration |
Primary outcome
Readmission due to infection.
Time frame: From 1-21 days after end of first course of antibiotic treatment.
Readmission due to infection, defined as symptoms, affected biomarkers and antibiotic treatment > 72 hours
Death
Time frame: From 1-21 days after end of first course of antibiotic treatment.
Death of any cause
Total use of antibiotics
Time frame: From initiation of antibiotics and the next 28 days.
Use of antibiotics (in hours)
2 secondary outcomes
C-reactive protein (CRP)
Time frame: CRP measured at follow-up 2 days after initial antibiotic treatment ended
Readmission due to infection within 3 months
Time frame: From 1-100 days after first course of antibiotics ended.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Derived from this study: PubMed 42302804Carlsen EM, Hansen BM, Dungu KHS, Lindhard MS, Gudiksen A, Aunsholt L, Viuff AC, Zacharaissen G, Greisen G, Lewis A, Holm SK, Dayani G, Pedersen P, Vibede LD, Stanchev H, Jensen KV, Fenger-Gron J, Lund S, Agergaard P, Bender L, Ryttov K, Milovanov V, Skovgaard AL, Vandborg PK, Hedegaard SS, Blanche P, Nygaard U, Henriksen TB. Individualised duration of antibiotic treatment in culture-negative early-onset sepsis in late-preterm and term-born neonates in Denmark (DURATION): a multicentre, open-label, randomised, controlled, non-inferiority trial. Lancet Child Adolesc Health. 2026 Aug;10(8):573-583. doi: 10.1016/S2352-4642(26)00118-5. Epub 2026 Jun 16.
- Individual participant dataSharing planned: Yes. Researchers who provide a methodologically sound proposal will be granted access to a full copy of individual deidentified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Malchau Carlsen, MD, PhD principal investigator
Department of Neonatology, Rigshospitalet, Copenhagen, Denmark
Tine Brink Henriksen, MD, Prof study director
Department of Neonatology, Skejby Sygehus, Aarhus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Individualized treatment duration strategy in people with Early-Onset Neonatal Sepsis and Antibiotic Side Effect, run by Ulrikka Nygaard at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission due to infection. (time frame: From 1-21 days after end of first course of antibiotic treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05329701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.