Individualized antibiotic treatment duration for newborns with early-onset infection
Individualized Duration of Antibiotic Treatment in Culture Negative Early Onset Infection in Term Born Newborns: A Nationwide Randomized Controlled Non-inferiority Trial.
This study is testing if giving newborns with early-onset infection shorter, personalized antibiotic treatments based on their symptoms and blood tests can be just as safe and effective as the usual seven-day course.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 488 (estimated) |
| Ages | 1 Hour to 72 Hours |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05329701 on ClinicalTrials.gov |
What this trial studies
This trial is a nationwide multicenter open-label randomized controlled non-inferiority trial that compares individualized antibiotic treatment duration to the standard seven-day treatment for culture-negative early-onset infection in term newborns. The study evaluates the impact of stopping antibiotics based on clinical assessment and CRP levels, aiming to reduce unnecessary antibiotic exposure. By assessing symptoms and CRP levels, the trial seeks to determine if a tailored approach can safely shorten antibiotic therapy without increasing the risk of relapse.
Who should consider this trial
Good fit: Ideal candidates are term newborns with a gestational age of 35 weeks or more and a birth weight of at least 2000 grams who show signs of early-onset infection.
Not a fit: Patients with positive blood cultures or those who meet criteria to stop antibiotics within 48 hours will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce antibiotic exposure in newborns, minimizing side effects and antibiotic resistance.
How similar studies have performed: Other studies have indicated that individualized treatment approaches can be effective, but this specific method for early-onset infection in newborns is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Copenhagen
- Ulrikka Nygaard — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Emma Malchau Carlsen, MD, PhD — Department of Neonatology, Rigshospitalet, Copenhagen, Denmark
- Study coordinator: Emma Malchau Carlsen, MD,PhD
- Email: emma.louise.malchau.carlsen@regionh.dk
- Phone: +4527380508
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.