Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
58
Countries
1
Sites
1
Systemic infections
To investigate the impact of early MIPD-guided dosing on target attainment of three beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam and meropenem) in critically ill children.
Key facts
- Sponsor
- Universitair Ziekenhuis Gent
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 30 Apr 2025 → ongoing
- Decision date (initial)
- 2024-11-07
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- University Hospital Ghent · Fonds voor Innovatie en Klinisch Onderzoek UZ Gent (FIKO)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
To investigate the impact of early MIPD-guided dosing on target attainment of three beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam and meropenem) in critically ill children.
Secondary objectives 3
- To evaluate whether early MIPD of beta-lactams increases the proportion of subjects reaching the therapeutic target 100% fT>MIC at 120 hours after start of treatment, when compared to the use of fixed standard-of-care dosing regimens.
- To evaluate whether early MIPD of beta-lactams increases the proportion of subjects reaching the therapeutic target fT>MIC 100% within the interval 48 to 72 hours after start of treatment, when compared to the use of fixed standard of-care dosing regimens
- To evaluate whether early MIPD of beta-lactams reduces hospital length-of-stay, when compared to the use of fixed standard-of-care dosing regimens
Conditions and MedDRA coding
Systemic infections
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Fixed dosing regimens vs. dosing regimens based on prediction by MIPD calculator The overall objective of this study is to investigate the impact of early MIPD-guided dosing on target attainment of three beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam and meropenem) in critically ill children.
|
Randomised Controlled | Single | [{"id":116298,"code":1,"name":"Subject"},{"id":116297,"code":4,"name":"Analyst"}] | Comparator arm: Fixed standard-of-care dosing regimens based on height, weight and renal function Intervention arm: Dosing regimens based on prediction of starting and follow-up doses by MIPD calculator software |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Subject aged between 0 - 17 years 10 months
- Subject admitted to a participating ward unit (NICU, PICU, PHO unit)
- Strongly suspected or confirmed systemic infection
- Subject planned to start on intravenous amoxicillin-clavulanic acid, piperacillin-tazobactam or meropenem treatment at least aimed for a minimum duration of two days at time of inclusion. If the subject was previously treated with the same beta-lactam, the minimum interval to the previous beta-lactam treatment episode is 40 hours for amoxicillin-clavulanic acid (based on elimination half-life) and 8 hours for piperacillin-tazobactam and meropenem (based on elimination half-life)
- Informed consent/assent signed by parents or legal representatives of the subject.
- Not previously enrolled in this trial
Exclusion criteria 7
- Subject with serum creatinine level ≥ 2 mg/L at inclusion.
- Subject receiving (or planned to receive) haemofiltration, extracorporeal membrane oxygenation, hemodialysis or peritoneal dialysis, molecular adsorbent recirculating system or any other exchange technique
- Subject receiving (or planned to receive) body cooling
- Subject death is deemed imminent and inevitable
- Reporting of first dosing advice (based on blood sampling) is not possible within 28 hours after start treatment
- The subject is known or suspected to be pregnant
- The subject has a known allergy to the specific beta-lactam antibiotic
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of subjects reaching the therapeutic target 100% fT>MIC at 48 hours after start of beta-lactam treatment
Secondary endpoints 3
- Proportion of subjects reaching the therapeutic target 100% fT>MIC at 120 hours after start of treatment
- Proportion of subjects reaching the therapeutic target 100% fT>MIC within the interval 48 to 72 hours after start of treatment
- Hospital length-of-stay
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SCP109545371 · ATC
- Active substance
- Amoxicillin Sodium
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 672000 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND BETA-LACTAMASE INHIBITOR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP101876674 · ATC
- Active substance
- Linezolid
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6000 mg milligram(s)
- Max total dose
- 336000 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DH02 — MEROPENEM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1153878 · ATC
- Active substance
- Piperacillin Sodium
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1600 mg milligram(s)
- Max total dose
- 896000 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CR05 — PIPERACILLIN AND BETA-LACTAMASE INHIBITOR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP10330863 · ATC
- Active substance
- Amoxicillin Sodium
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 672000 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Ziekenhuis Gent
- Sponsor organisation
- Universitair Ziekenhuis Gent
- Address
- Corneel Heymanslaan 10
- City
- Gent
- Postcode
- 9000
- Country
- Belgium
Scientific contact point
- Organisation
- Universitair Ziekenhuis Gent
- Contact name
- Prof. Dr. Pieter De Cock
Public contact point
- Organisation
- Universitair Ziekenhuis Gent
- Contact name
- Prof. Dr. Pieter De Cock
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 58 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-04-30 | 2025-07-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 23 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2024-516447-12-00_redacted | 2.0 |
| Protocol (for publication) | D1_ Protocol Annex 1 2024-516447-12-00 | 2.0 |
| Protocol (for publication) | D1_ Protocol Annex 2 2024-516447-12-00 | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Children 12-17y_EN_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Children 12-17y_FR_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Children 12-17y_NL_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Parents or Guardian_EN_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Parents or Guardian_FR_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Parents or Guardian_NL_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF sponsor statement_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Information leaflet deffered consent parents or guardian_EN | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Information leaflet deffered consent parents or guardian_FR | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Information leaflet deffered consent parents or guardian_NL | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Amoxicillin | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Amoxicillin-clavulanic acid 1000mg-200mg | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Amoxicillin-clavulanic acid 500mg-50mg | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Meropenem | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Piperacillin-Tazobactam | 1.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_DE 2024-516447-12-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_EN 2024-516447-12-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_FR 2024-516447-12-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_NL 2024-516447-12-00 | 2.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-20 | Belgium | Acceptable 2024-11-07
|
2024-11-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-14 | Belgium | Acceptable 2024-11-07
|
2025-03-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-19 | Belgium | Acceptable 2024-11-07
|
2025-03-19 |