Oral Switch in Pediatric Bloodstream Infections

ConditionsBloodstream Infection Bacteremia Sepsis

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age4-17

SponsorUlrikka Nygaard

About this trial

This nationwide, multicenter, randomized, non-inferiority trial of children and adolescents with uncomplicated bloodstream infections aims to investigate if early-oral antibiotic switch (experimental arm) is non-inferior to standard intravenous antibiotics (control arm) with respect to treatment failure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 4 weeks to 17 years

Positive blood culture with a i) pathogenic bacterium (eg, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacterales, Fusobacterium spp. and other pathogenic bacteria) or ii) preliminary blood culture result (eg, Gram-negative rods or Gram-positive cocci in clusters/chains) judged by the investigator to be clinically relevant (ie, not a contaminant) and for which IV antibiotic therapy would be indicated according to standard guidelines

Clinical stability, defined as: (a) respiratory and haemodynamic stability, without need for oxygen, IV fluid therapy or inotropic support; and (b) well-appearing with signs of clinical improvement (eg, improved physical activity), as judged by the investigator

Tolerating oral fluids and diet, as judged by the investigator

Disqualifiers

Complicated infections: a. Suspicion of endocarditis (echocardiography not performed routinely), b. Suspicion of CNS infection or post-septal cellulitis, c. Foreign material (eg, bone infection involving prosthetic material). d. Complicated postoperative course (eg, perforated appendicitis)

Blood culture positive with a. Neisseria meningitidis, b. Streptococcus pneumoniae if afebrile within 24 hours of blood culture collection, c. bacteria considered possible contaminants (eg, coagulase-negative staphylococci, Corynebacterium spp., Micrococcus spp.)

Premature infants with a corrected age of less than 28 days

No available suitable oral antibiotic (eg, due to antimicrobial resistance or contraindications)

Trial design

Design model

Parallel

Treatments tested in this trial

Oral antibiotic therapy
Drug
Participants randomised to the experimental arm will switch to oral antibiotic therapy as soon as possible after clinical stability and within 4 days after initiation of effective IV antibiotic therapy. Children who have not received antibiotics, or who have received oral antibiotics before the blood culture becomes positive, may also be randomised; thus, prior IV therapy is not required in the experimental arm.
Standard IV antibiotic therapy
Drug
Participants allocated to the control group will continue IV therapy for at least 5 days after initiation of effective IV antibiotic therapy, with 7 days recommended, followed by oral step-down if appropriate.

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Early Oral SwitchExperimental treatment 1 intervention

Group B: Standard Intravenous TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

Number of Participants with Treatment Failure

Treatment failure, defined as clinically and/or microbiologically confirmed disease progression or relapse, adjudicated by an independent, blinded adjudication committee.

Time frame