Bloodstream InfectionPhase 4Oral_SwitchNCT07923266
Oral Switch in Bloodstream Infections in Immunocompromised Children
A Phase 4 study testing Oral antibiotic therapy and Standard IV antibiotic therapy in people with Bloodstream Infection and Bloodstream Infection Due to Central Venous Catheter, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
Trial summary
This nationwide, multicenter, randomized non-inferiority trial aims to determine whether an switch to oral antibiotic therapy (experimental arm) is non-inferior to standard intravenous antibiotic therapy (control arm) with respect to recurrence in children and adolescents with uncomplicated bloodstream infections, who… Read more about this study
- Who is it for?
- Ages 4 weeks to 17 years
- Conditions the study is for
- Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter, Immunocompromised Patients
- What is being tested?
- Oral antibiotic therapy and Standard IV antibiotic therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 4 sitesDenmark
- Study dates
- 1 Nov 2026to 1 Feb 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4 weeks to 17 years
- Underlying medical condition associated with immunosuppression and/or presence of a central venous catheter
- Positive blood culture with a high-pathogenic bacterium. Eligible pathogens include Gram-negative bacteria and Gram-positive bacteria such as Staphylococcus aureus, Streptococcus mitis, Streptococcus pneumoniae, β-haemolytic streptococci, and Enterococcus spp., for which standard treatment is at least 7 days of intravenous antibiotics.
- Clinical stability, defined as: (a) respiratory and hemodynamically stable, without need for oxygen, IV fluid therapy or inotropic support; and (b) well-appearing with signs of clinical improvement (e.g., improved physical activity), as judged by the investigator
- Afebrile for 24 hours.
- Tolerating oral fluids and diet and considered to have adequate gastrointestinal absorption for age, as judged by the investigator
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- Within the randomization window: i) As soon as possible after eligibility is confirmed and ii) within 3-6 days of effective IV antibiotics (72-144 hours) including the duration of the last IV dose.
- Informed consent obtained from a parent or guardian, and from the patient if of appropriate age.
- Polymicrobial episodes are allowed
Who cannot join
- Complicated infections
- Tunnel infection associated with a CVC, unless the CVC is removed
- Suspected CNS infection
- Other focal infections requiring prolonged antibiotic therapy beyond the treatment of bacteremia, e.g., deep-seated abscess or other deep-seated infections, bone or joint infections, and endocarditis
- Blood culture with Pseudomonas aeruginosa, Neisseria meningitidis, or low-pathogenic possible contaminants of uncertain clinical relevance, including coagulase-negative staphylococci, Micrococcus spp., Corynebacterium spp., Cutibacterium acnes, and Bacillus spp.
- Clinically significant mucositis (e.g. stomatitis CTCAE (Common Terminology Criteria for Adverse Events) grade ≥3, defined as severe pain interfering with oral intake)
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- No suitable oral antibiotic available (e.g., due to antimicrobial resistance or contraindications)
- Within the follow-up period (≤6 weeks) of a previous randomization for another pathogen covered by the antibiotic indicated for the index episode.
- Planned to receive prophylactic antibiotic therapy covering the pathogen after completion of treatment for the index infection
- A decision to discontinue life-prolonging treatment has been made, with a life expectancy of less than 6 weeks, as assessed by the treating physician.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark4 sites
Department of Pediatrics, Aalborg University Hospital
Aalborg
Jesper Thaarup, MD, jeth@rn.dk
Aarhus University Hospital
Aarhus
Mette Holm, MD PhD, +4522952218, mette.holm@skejby.rm.dk
Copenhagen University Hospital
Copenhagen, 2100
Ulrikka Nygaard, MD, PhD, DrMedSci, +4540794656, ulrikka.nygaard@regionh.dk
Nadja H Vissing, MD PhD, +4521790640, nadja.hawwa.vissing@regionh.dk
Hans Christian Andersen Children's Hospital, Odense University Hospital
Odense
Ulla Hartling, MD PhD, Ulla.hartling@rsyd.dk
About this study
Official title: Oral Switch Versus Standard Intravenous Antibiotics in Children and Adolescents Who Are Immunocompromised and/or a Central Venous Catheter and Uncomplicated Bloodstream Infections: a Nationwide Randomised Controlled Non-inferiority Trial
This nationwide, multicenter, randomized non-inferiority trial aims to determine whether an switch to oral antibiotic therapy (experimental arm) is non-inferior to standard intravenous antibiotic therapy (control arm) with respect to recurrence in children and adolescents with uncomplicated bloodstream infections, who are immunocompromised or have a central venous catheter.
Read the detailed description
Background:
Bloodstream infections are among the leading causes of hospital admission and prolonged intravenous (IV) antibiotic therapy in children and adolescents. Current international guidelines recommend IV-only therapy or prolonged IV treatment before switching to oral antibiotics. However, these recommendations are primarily based on historical convention and low-quality evidence rather than randomized controlled trials (RCTs). Studies in both adults and children with serious infections other than bloodstream infections suggest that shorter IV courses followed by oral step-down therapy may be safe and effective. However, no RCT has specifically investigated an early switch to oral antibiotic therapy in immunocompromised children and/or those with a central venous catheter (CVC). Although these children may be at increased risk of infectious complications, they also experience a substantial proportion of pediatric bloodstream infections and prolonged IV antibiotic courses. Consequently, the potential impact of a safe early oral-switch strategy may be particularly important in this population.
Objective:
The trial objective is to determine whether early IV-to-oral antibiotic switch is non-inferior to continued standard IV therapy with respect to recurrence of bloodstream infection in clinically stable children and adolescents aged 4 weeks to 17 years with immunosuppression and/or have a CVC and have a bloodstream infection.
Study design:
This is an investigator-initiated, nationwide, open-label, parallel-group, randomized (1:1), controlled, non-inferiority trial, with randomization stratified by 1) Bacteria type (Gram positive vs. Gram negative), and 2) planned CVC removal (removal versus retention or no CVC, as determined before randomization).
Patients:
Children and adolescents aged 4 weeks to 17 years with underlying medical condition associated with immunosuppression and/or the presence of a CVC, and have a bloodstream infections will be recruited from all 18 pediatric departments in Denmark.
Procedure:
Eligible children will be randomized 1:1 to an early oral switch strategy or standard IV therapy. The choice of oral and IV antibiotics will not be determined by randomization but will be made by the treating clinician according to the isolated pathogen, antimicrobial susceptibility, and current treatment guidelines. The total antibiotic treatment duration will be the same in both treatment groups, according to Danish guidelines.
Participants will be randomized to the early oral switch arm (experimental arm) or the standard IV arm (control arm).
Participants allocated to the early oral switch arm will receive effective IV antibiotic therapy for at least 3 days and switch to oral therapy as soon as possible after clinical stability, but no later than day 6, to complete a total treatment duration of 10-14 days according to clinical treatment guidelines. Participants allocated to the standard IV arm (control arm) will receive IV antibiotic therapy for the full treatment course.
Sample size calculation:
The study aims to enroll a minimum of 114 participants. The sample size calculation is based on an expected treatment failure risk of 1.5% in both treatment arms, a non-inferiority margin of 10 percentage points, a one-sided alpha level of 2.5%, and the use of an appropriate statistical method that accounts for the expected low number of events. Assuming a dropout rate of up to 5%, enrollment of 114 participants will provide approximately 80% power to demonstrate non-inferiority.
Recruitment is planned for approximately 36 months and may be extended if required and feasible to achieve the target sample size. If 114 participants are enrolled within the initial 36-month recruitment period, enrollment will continue until the end of the 36-month recruitment period or until a maximum of 150 participants have been enrolled, whichever occurs first, to increase statistical power to approximately 90%.
- Conditions
- Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter, Immunocompromised Patients, Bacteremia Sepsis
- Being tested
- Oral antibiotic therapy, Standard IV antibiotic therapy
- Keywords
- oral antibiotics, bacteremia, oral step-down, children, pediatrics, CHILD, blood stream infection, CLABSI, immunocompromised
- Medical subject headings
- Sepsis, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral antibiotic therapyDrug
Participants randomized to the experimental arm will switch from IV to oral antibiotic therapy after effective IV antibiotic therapy for at least 3 days, followed by oral therapy as soon as possible after clinical stability, but no later than day 6, and continue oral therapy to complete the recommended total treatment duration.
Standard IV antibiotic therapyDrug
Participants randomised to the control arm will receive IV antibiotic therapy throughout the recommended total treatment duration.
| Study group | Role | What they receive |
|---|---|---|
| Early Oral Switch | Experimental | Early Oral Switch Receives: Drug: Oral antibiotic therapy |
| Standard Intravenous Therapy | Active comparator | Standard Intravenous Therapy Receives: Drug: Standard IV antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of blood stream infection
Number of patients who experience growth of the same bacteria as in the index blood stream infection in a subsequent blood culture during the follow-up period.
Measured: Within 6 weeks after randomization
Secondary outcomes (1)
IV antibiotic treatment duration
Duration of IV antibiotic treatment from randomization until completion of IV antibiotic treatment for the index bloodstream infection, measured in hours.
Measured: Within 6 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrikka Nygaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923266
- Sponsor's protocol ID
- H-25090709_IIa
- Acronym
- Oral_Switch
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Switch Versus Standard Intravenous Antibiotics in Children and Adolescents Who Are Immunocompromised and/or a Central Venous Catheter and Uncomplicated Bloodstream Infections: a Nationwide Randomised Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT07923266
- Acronym / sponsor ID
- Oral_Switch / H-25090709_IIa
- Conditions
- Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter, Immunocompromised Patients, Bacteremia Sepsis
- Keywords
- oral antibiotics, bacteremia, oral step-down, children, pediatrics, CHILD, blood stream infection, CLABSI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This nationwide, multicenter, randomized non-inferiority trial aims to determine whether an switch to oral antibiotic therapy (experimental arm) is non-inferior to standard intravenous antibiotic therapy (control arm) with respect to recurrence in children and adolescents with uncomplicated bloodstream infections, who are immunocompromised or have a central venous catheter.
Detailed description
Background:
Bloodstream infections are among the leading causes of hospital admission and prolonged intravenous (IV) antibiotic therapy in children and adolescents. Current international guidelines recommend IV-only therapy or prolonged IV treatment before switching to oral antibiotics. However, these recommendations are primarily based on historical convention and low-quality evidence rather than randomized controlled trials (RCTs). Studies in both adults and children with serious infections other than bloodstream infections suggest that shorter IV courses followed by oral step-down therapy may be safe and effective. However, no RCT has specifically investigated an early switch to oral antibiotic therapy in immunocompromised children and/or those with a central venous catheter (CVC). Although these children may be at increased risk of infectious complications, they also experience a substantial proportion of pediatric bloodstream infections and prolonged IV antibiotic courses. Consequently, the potential impact of a safe early oral-switch strategy may be particularly important in this population.
Objective:
The trial objective is to determine whether early IV-to-oral antibiotic switch is non-inferior to continued standard IV therapy with respect to recurrence of bloodstream infection in clinically stable children and adolescents aged 4 weeks to 17 years with immunosuppression and/or have a CVC and have a bloodstream infection.
Study design:
This is an investigator-initiated, nationwide, open-label, parallel-group, randomized (1:1), controlled, non-inferiority trial, with randomization stratified by 1) Bacteria type (Gram positive vs. Gram negative), and 2) planned CVC removal (removal versus retention or no CVC, as determined before randomization).
Patients:
Children and adolescents aged 4 weeks to 17 years with underlying medical condition associated with immunosuppression and/or the presence of a CVC, and have a bloodstream infections will be recruited from all 18 pediatric departments in Denmark.
Procedure:
Eligible children will be randomized 1:1 to an early oral switch strategy or standard IV therapy. The choice of oral and IV antibiotics will not be determined by randomization but will be made by the treating clinician according to the isolated pathogen, antimicrobial susceptibility, and current treatment guidelines. The total antibiotic treatment duration will be the same in both treatment groups, according to Danish guidelines.
Participants will be randomized to the early oral switch arm (experimental arm) or the standard IV arm (control arm).
Participants allocated to the early oral switch arm will receive effective IV antibiotic therapy for at least 3 days and switch to oral therapy as soon as possible after clinical stability, but no later than day 6, to complete a total treatment duration of 10-14 days according to clinical treatment guidelines. Participants allocated to the standard IV arm (control arm) will receive IV antibiotic therapy for the full treatment course.
Sample size calculation:
The study aims to enroll a minimum of 114 participants. The sample size calculation is based on an expected treatment failure risk of 1.5% in both treatment arms, a non-inferiority margin of 10 percentage points, a one-sided alpha level of 2.5%, and the use of an appropriate statistical method that accounts for the expected low number of events. Assuming a dropout rate of up to 5%, enrollment of 114 participants will provide approximately 80% power to demonstrate non-inferiority.
Recruitment is planned for approximately 36 months and may be extended if required and feasible to achieve the target sample size. If 114 participants are enrolled within the initial 36-month recruitment period, enrollment will continue until the end of the 36-month recruitment period or until a maximum of 150 participants have been enrolled, whichever occurs first, to increase statistical power to approximately 90%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Oral Switch | Experimental | Drug: Oral antibiotic therapyEarly Oral Switch |
| Standard Intravenous Therapy | Active comparator | Drug: Standard IV antibiotic therapyStandard Intravenous Therapy |
Who may qualify
- Ages
- 4 weeks to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Age 4 weeks to 17 years
- Underlying medical condition associated with immunosuppression and/or presence of a central venous catheter
- Positive blood culture with a high-pathogenic bacterium. Eligible pathogens include Gram-negative bacteria and Gram-positive bacteria such as Staphylococcus aureus, Streptococcus mitis, Streptococcus pneumoniae, β-haemolytic streptococci, and Enterococcus spp., for which standard treatment is at least 7 days of intravenous antibiotics.
- Clinical stability, defined as: (a) respiratory and hemodynamically stable, without need for oxygen, IV fluid therapy or inotropic support; and (b) well-appearing with signs of clinical improvement (e.g., improved physical activity), as judged by the investigator
- Afebrile for 24 hours.
Key exclusion criteria (10 listed)
- Complicated infections
- Blood culture with Pseudomonas aeruginosa, Neisseria meningitidis, or low-pathogenic possible contaminants of uncertain clinical relevance, including coagulase-negative staphylococci, Micrococcus spp., Corynebacterium spp., Cutibacterium acnes, and Bacillus spp.
- Clinically significant mucositis (e.g. stomatitis CTCAE (Common Terminology Criteria for Adverse Events) grade ≥3, defined as severe pain interfering with oral intake)
- No suitable oral antibiotic available (e.g., due to antimicrobial resistance or contraindications)
- Within the follow-up period (≤6 weeks) of a previous randomization for another pathogen covered by the antibiotic indicated for the index episode.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral antibiotic therapyParticipants randomized to the experimental arm will switch from IV to oral antibiotic therapy after effective IV antibiotic therapy for at least 3 days, followed by oral therapy as soon as possible after clinical stability, but no later than day 6, and continue oral therapy to complete the recommended total treatment duration. | Drug | Early Oral Switch |
| Standard IV antibiotic therapyParticipants randomised to the control arm will receive IV antibiotic therapy throughout the recommended total treatment duration. | Drug | Standard Intravenous Therapy |
Primary outcome
Recurrence of blood stream infection
Time frame: Within 6 weeks after randomization
Number of patients who experience growth of the same bacteria as in the index blood stream infection in a subsequent blood culture during the follow-up period.
1 secondary outcome
IV antibiotic treatment duration
Time frame: Within 6 weeks after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral antibiotic therapy and Standard IV antibiotic therapy in people with Bloodstream Infection and Bloodstream Infection Due to Central Venous Catheter, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulrikka Nygaard, MD, PhD, DrMedSci (+4540794656, ulrikka.nygaard@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of blood stream infection (time frame: Within 6 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.