Clinical Trials Logo

Clinical Trial Summary

Randomized controlled open-label non-inferiority trial comparing complete intravenous antibiotic treatment with a short iv. course followed by oral antibiotics in neonates (0-28 days) with probable bacterial infection. Primary outcome: - Bacterial re-infection within 28 days after finishing of antibacterial therapy. Secondary outcome(s): - Pharmacokinetic profile of oral amoxicillin/clavulanic acid - Quality of life - Cost-effectiveness - Alterations in gut microbiome - Use of molecular techniques for better detection of bacterial pathogens


Clinical Trial Description

Neonates have a high antibiotic consumption because of their susceptibility for bacterial infections. Since the early diagnosis of bacterial infection in neonates is difficult, intravenous broad-spectrum antimicrobial therapy is usually started promptly after subtle symptoms. The majority of neonates become asymptomatic shortly after initiation; when infection is probable or proven by elevated inflammatory markers and/or a positive blood culture, intravenous antibiotics are administered for at least 7 days. However, for neonates blood culture has a limited sensitivity. Therefore, the majority of neonates with probable infection are treated for a prolonged time with intravenous broad-spectrum antimicrobial therapy. In older children, intravenous antibiotics are often changed to oral antibiotics after cessation of symptoms and decreasing inflammatory parameters. This is not yet widely practised in neonates because of uncertainties in pharmacokinetics. Two explorative small studies from France and Italy into neonatal antibiotic switch therapy suggest that follow-up treatment with an oral antibiotic is promising; but the non-inferiority and safety was not yet properly addressed. Neonatal switch therapy, if proven to be safe and efficacious, would have a major impact on neonatal well-being, mother-to-child bonding and moreover costs. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03247920
Study type Interventional
Source Franciscus Gasthuis
Contact
Status Completed
Phase Phase 4
Start date November 4, 2017
Completion date July 15, 2021

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05692128 - Frequency and Severity of Thrombocytopenia in Neonatal Sepsis
Completed NCT00942084 - A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo) Phase 1
Completed NCT06002295 - A Comparative Analysis of 4% Chlorhexidine Versus Methylated Spirit as Prophylaxis of Omphalitis and Sepsis in Newborns Phase 2
Not yet recruiting NCT05114057 - Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI N/A
Recruiting NCT04528251 - Comparison of the Effectiveness of Two Different Antibiotic Regimens of the Treatment of Pregnant Women With Preterm Rupture of Membranes
Active, not recruiting NCT03871491 - Azithromycin-Prevention in Labor Use Study (A-PLUS) Phase 3
Completed NCT03746743 - Severity Index of Neonatal Septicemia Using Score for Neonatal Acute Physiology (SNAP) II
Completed NCT02386592 - Prevention of Nosocomial Bacteremia Among Zambian Neonates N/A
Not yet recruiting NCT06113653 - Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis
Completed NCT03199547 - Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death Phase 3
Completed NCT02147327 - Effects of Cord Blood 25-hydroxy-vitamin D Level on Early Neonatal Morbidities N/A
Completed NCT01005589 - CD64 Measurement in Neonatal Infection and Necrotising Enterocolitis N/A
Completed NCT00866567 - Defects in Opsonophagocytosis in Premature Infants N/A
Completed NCT02281890 - Neurodevelopmental Outcomes After Suspected or Proven Sepsis: Secondary Analysis of INIS Trial Database N/A
Suspended NCT05156333 - Probiotics and GBS Colonization in Pregnancy N/A
Recruiting NCT05127070 - Evaluating the NeoTree in Malawi and Zimbabwe
Completed NCT03755635 - Neonatal Sepsis at Neonatal Intensive Care Units in Ghana N/A
Completed NCT03295162 - Effects of Melatonin as a Novel Antioxidant and Free Radicals Scavenger in Neonatal Sepsis Phase 1/Phase 2
Completed NCT02954926 - Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis Phase 3
Withdrawn NCT01723501 - Chlorhexidine Skin Application for Prevention of Infection in Infants Weighing <1500 g at Birth Phase 2/Phase 3