Overview
Sponsor-declared trial summary
Sepsis
To investigate target attainment at 5 days after treatment initiation in patients receiving TDM- guided dosing versus patients receiving standard dosing.
Key facts
- Sponsor
- Stichting Radboud University Medical Center
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 17 Aug 2023 → 20 Feb 2026
- Decision date (initial)
- 2023-06-01
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ZonMW
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Pharmacokinetic, Therapy
To investigate target attainment at 5 days after treatment initiation in patients receiving TDM- guided dosing versus patients receiving standard dosing.
Secondary objectives 4
- • To estimate the time until target attainment in patients receiving TDM- guided dosing versus patients receiving standard dosing
- • To investigate the incidence of clinical failure at day 30 in patients receiving TDM- guided dosing versus patients receiving standard dosing.
- • To investigate the length of hospital stay after treatment with teicoplanin in patients receiving TDM- guided dosing versus patients receiving standard dosing
- • To explore the relation between exposure of teicoplanin and nephrotoxicity
Conditions and MedDRA coding
Sepsis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1. The patient is admitted to the Radboudumc
- 2. The patient is at least 18 years old on the day of inclusion.
- 3. The patient is treated with teicoplanin as part of standard care.
- 4. The patient or a representative is willing to sign the Informed Consent Form.
Exclusion criteria 4
- 1. The patient has previously participated in this study.
- 2. The patient receives any form of RRT other than CVVHD / CVVHDF.
- 3. Expected duration of teicoplanin therapy is less than 5 days.
- 4. Pregnant individuals
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- • The difference in fraction of patients reaching pharmacokinetic target attainment of unbound teicoplanin concentrations at 5 days after start of treatment of the study group versus the control group.
Secondary endpoints 4
- • Time until reaching target attainment.
- • Incidence of clinical failure at day 30.
- • Total number of days in hospital
- • Incidence of AKI during teicoplanin treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Teicoplanin Hikma 400 mg Powder for solution for Injection/infusion or oral solution
PRD6056060 · Product
- Active substance
- Teicoplanin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 24 mg/Kg milligram(s)/kilogram
- Max total dose
- 18 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01XA02 — TEICOPLANIN
- Marketing authorisation
- PA 1217/010/002
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Radboud University Medical Center
- Sponsor organisation
- Stichting Radboud University Medical Center
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Radboud University Medical Center
- Contact name
- Nynke Jager
Public contact point
- Organisation
- Stichting Radboud University Medical Center
- Contact name
- Nynke Jager
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 74 | 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 |
|---|---|---|---|---|---|
| Netherlands | 2023-08-17 | 2023-08-23 | 2026-02-12 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-119113
- Halt date
- 2026-02-12
- Member states concerned
- Netherlands
- Publication date
- 2026-02-12
- Reason
- Safety related (clinical or pre-clinical results)
- Follow-up measures
- Added value of continuing the study will be evaluated.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol redacted 2023-503411-15-00 | 2 |
| Recruitment arrangements (for publication) | K1 recruitment procedures | 3 |
| Subject information and informed consent form (for publication) | L1 Informatiebrieftoestemmingsformulier incapacitated patients | 4 |
| Subject information and informed consent form (for publication) | L1 Informatiebrieftoestemmingsformulier redacted | 4 |
| Subject information and informed consent form (for publication) | L1 Informatiebrieftoestemmingsformulier wettelijk vertegenwoordiger | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SmPC | 1 |
| Synopsis of the protocol (for publication) | D1 Dutch synopsis | 2 |
| Synopsis of the protocol (for publication) | D1 English synopsis | 2 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-22 | Netherlands | Acceptable 2023-05-30
|
2023-06-01 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-07-20 | Netherlands | Acceptable 2023-05-30
|
2023-07-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-05 | Netherlands | Acceptable 2025-07-01
|
2025-07-01 |