INTRAVENOUS-TO-ORAL ANTIBIOTIC SWITCH THERAPY FOR SUSPECTED NEONATAL BACTERIAL INFECTIONS: ;CLINICAL EFFICACY, SAFETY AND COST-EFFECTIVENESS

Phase 4

Completed

• Conditions: neonatal infection; 10004018

• Registration Number: NL-OMON47298
• Lead Sponsor: Sint Franciscus Gasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-06-14
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 510

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 CRP and/or elevated PCT according to age-related normogram7) for which empiric broad-spectrum antimicrobial treatment was initiated and needs 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;For the specific PK-study, neonates also can participate when they fulfill the inclusion criteria and are given oral amoxicillin/clavulanic acid not for this specific trial but for another reason.

Exclusion Criteria

* proven bloodstream infection
* absence of blood culture (i.e. no blood culture taken)
* severe localized infection such as meningitis, osteomyelitis, necrotizing enterocolitis (except pneumonia and urinary tract infection)
* severe clinical sepsis on admission (compromised circulation; need for mechanical ventilation)
* known (maternal) colonization with resistant bacteria such as MRSA, ESBL-producing bacteria
* continuous need for central venous line (umbilical venous catheter, PICC)
* severe hyperbilirubinaemia with need for phototherapy
* 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Bacterial (re)-infection within 28 days after finishing of antimicrobial<br /><br>therapy ((defined as clinical signs and symptoms of bacterial infection and<br /><br>fever (> 38.0 deg C) or undertemperature (< 36.0 deg C) and elevated<br /><br>inflammatory parameters (CRP, PCT) and need for prolonged (> 48 h) antibiotic<br /><br>treatment)).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* duration of hospitalization<br /><br>* percentage re-admission<br /><br>* total costs and cost-effectiveness<br /><br>* clinical side effects of antibiotics<br /><br>* pharmacokinetic profile of oral amoxicillin<br /><br>* pharmacokinetic profile of oral clavulanic acid<br /><br>* quality of life (painful procedures; breastfeeding; sleep quality;<br /><br>gastro-intestinal symptoms; parental satisfaction)<br /><br>* nosocomial infections<br /><br>* gut microbial flora profile and antimicrobial resistance genes</p><br>