Reduction of intravenous antibiotics in neonates (RAIN) study

Phase 1

• Conditions: eonatal probable bacterial infection; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-004447-36-NL
• Lead Sponsor: Stichting Rotterdams Onderzoeksconsortium Kindergeneeskunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-16
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Neonates, = 35+0 weeks of gestation, 0-28 days old, = 2.0 kg.

•probable bacterial infection (clinical symptoms and/or maternal risk factors and elevated inflammatory parameters (elevated PCT according to age-related normogram and/or elevated CRP)) for which empiric broad-spectrum antimicrobial treatment was initiated and need to be continued for > 48 hours at the discretion of the treating physician
•reassuring level and trends of inflammatory parameters 48-72 hours after initiation of antimicrobial treatment
•clinically stable
•tolerates oral feeding and/or liquids without overt vomiting
•written informed consent of parents or legal representatives

Are the trial subjects under 18? yes
Number of subjects for this age range: 600
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•proven bloodstream infection, failed blood culture
•severe localized infection such as meningitis, osteomyelitis, necrotizing enterocolitis (pneumonia and urinary tract infection excluded)
•severe clinical sepsis on admission (compromised circulation; need for mechanical ventilation)
•known colonization with resistant bacteria such as MRSA, ESBL-producing bacteria
•continuous need for central venous line (umbilical venous catheter, PICC)
•clinicians’ decision to continue with intravenous antibiotics because of other reasons
•parents’ inability to administer medication because of social reasons or language difficulties

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified