A clinical study of the use of teicoplanin in children with blood cancer to prevent infections

An open-label, randomized clinical trial on teicoplanin infection prophylaxis in pediatric patients with acute myeloid leukemia - Pro-Teico study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000508-13-BE

Enrollment

130

Registered

2022-04-11

Start date

2022-10-03

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia MedDRA version: 20.0 Level: LLT Classification code 10024346 Term: Leukemia myeloblastic acute System Organ Class: 100000004864

Interventions

Trade Name: Targocid Pharmaceutical Form: Powder and solvent for solution for injection/infusion INN or Proposed INN: Teicoplanin CAS Number: 61036-64-4 Concentration unit: µg/ml microgram(s)/millilit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Newly diagnosed with AML Being registered and starting treatment according to the NOPHO-DBH AML 2012 study protocol, or a consecutive protocol Age 0-19 years Written informed consent by the patient and/or legal guardians (whatever applicable according to the patients age) Are the trial subjects under 18? yes Number of subjects for this age range: 130 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Acute promyelocytic leukemia Secondary AML Down Syndrome Preexisting primary immunodeficiency Patients who receive regular antibiotic prophylaxis against Gram-positive bacteria for other conditions than leukemia-related Patients with a history of an anaphylactic reaction (CTCAE grade =3) to teicoplanin and/or vancomycin Patients with an eGFR of <30 ml/min/1.73m2 at the start of the study Patients with a history of severe impaired hearing (CTCAE grade =3) Pregnant or breast-feeding patients Patients that are participating in another clinical study with an IMP, that interferes with the study objectives

Design outcomes

Primary

Measure	Time frame
Main Objective: Safety run-in: To assess the safety of i.v. teicoplanin prophylaxis three times per week with a two to three days interval in children with newly-diagnosed AML. A patient will be considered evaluable for safety if they experience a DLT during a prophylactic cycle with teicoplanin or, in case no DLT occurs, if exposure to teicoplanin is either at least 2 consecutive weeks with at least 5 doses of teicoplanin or at least 3 weeks in total with at least 6 out of 9 doses of teicoplanin, or 8 out of 12 doses in case of 4 weeks, or 10 out of 15 doses in case of 5 weeks. Randomized phase: To evaluate whether i.v. teicoplanin prophylaxis in children with newly-diagnosed AML decreases the occurrence of culture-proven BSIs with VGS during treatment.;Secondary Objective: Safety run-in: To (preliminary) characterize the PK parameters of teicoplanin in children with newly-diagnosed AML. Randomized controlled trial: Evaluate whether i.v. teicoplanin prophylaxis decreases the occurrence of any culture-proven bacterial BSI; assess the impact of teicoplanin prophylaxis on the number of intensive care admissions; the frequency of infectious-related morbidity and mortality; evaluate whether i.v. teicoplanin prophylaxis affects neutrophil recovery time; development of teicoplanin-related bacterial resistance; The safety and AEs; To study if there is a confounding effect of the use of other antibiotics (e.g., fluoroquinolones) on the occurrence of culture-proven (VGS) bacterial BSIs; To assess PK parameters and construct a population PK model; To study the potential effect of co-variables on teicoplanin clearance; associations between serum levels of teicoplanin and the occurrence of culture-proven (VGS) bacterial BSIs. To describe the CIR, EFS and OS.;Primary end point(s): Safety run-in: The number of DLTs observed Randomized controlled trial: The (first) occurrence of culture-proven BSIs with VGS during initial AML treatment; Date(s) of BSI(s) with VGS ;Timepoint	—

Measure

Time frame

Main Objective: Safety run-in: To assess the safety of i.v. teicoplanin prophylaxis three times per week with a two to three days interval in children with newly-diagnosed AML. A patient will be considered evaluable for safety if they experience a DLT during a prophylactic cycle with teicoplanin or, in case no DLT occurs, if exposure to teicoplanin is either at least 2 consecutive weeks with at least 5 doses of teicoplanin or at least 3 weeks in total with at least 6 out of 9 doses of teicoplanin, or 8 out of 12 doses in case of 4 weeks, or 10 out of 15 doses in case of 5 weeks. Randomized phase: To evaluate whether i.v. teicoplanin prophylaxis in children with newly-diagnosed AML decreases the occurrence of culture-proven BSIs with VGS during treatment.;Secondary Objective: Safety run-in: To (preliminary) characterize the PK parameters of teicoplanin in children with newly-diagnosed AML. Randomized controlled trial: Evaluate whether i.v. teicoplanin prophylaxis decreases the occurrence of any culture-proven bacterial BSI; assess the impact of teicoplanin prophylaxis on the number of intensive care admissions; the frequency of infectious-related morbidity and mortality; evaluate whether i.v. teicoplanin prophylaxis affects neutrophil recovery time; development of teicoplanin-related bacterial resistance; The safety and AEs; To study if there is a confounding effect of the use of other antibiotics (e.g., fluoroquinolones) on the occurrence of culture-proven (VGS) bacterial BSIs; To assess PK parameters and construct a population PK model; To study the potential effect of co-variables on teicoplanin clearance; associations between serum levels of teicoplanin and the occurrence of culture-proven (VGS) bacterial BSIs. To describe the CIR, EFS and OS.;Primary end point(s): Safety run-in: The number of DLTs observed Randomized controlled trial: The (first) occurrence of culture-proven BSIs with VGS during initial AML treatment; Date(s) of BSI(s) with VGS ;Timepoint

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Secondary

Measure	Time frame
Secondary end point(s): Safety run-in: -Css,max -Css,min -Tss,max -Area under the curve -Clearance (inter-compartmental, total, renal fraction) -Volume of distribution (central and peripheral) Randomized controlled trial: 1. The number of BSIs with culture-proven bacteria 2. Results of all positive blood cultures 3. Infection-related (pediatric) intensive care admissions; 4. The number of episodes/admissions with (neutropenic) fever; days with fever (with or without neutropenia), days with FN, Days with neurtopenia 5. Infection-free survival time, i.e., time from diagnosis till first culture-proven BSI; 6. Infection-related mortality; 7. Number of days until neutrophil recovery (ANC of =0.5 x109/L following the nadir); 8. Resistance patterns of pathogenic isolates from blood cultures; 9. Incidence of resistant bacteria in throat and rectal cultures, e.g.,; VRE 10. AEs of special interest; 11. Serious adverse events (SAEs); 12. Use of (other) antibiotics, antifungals and antivirals; 13. Serum creatinine levels 14. Serum teicoplanine levels 15. Cumulative incidence of relapse 16. Event-free survival 17. Overall survival;Timepoint(s) of evaluation of this end point: During and after the safety run-in During the randomized controlled trial	—

Measure

Time frame

Secondary end point(s): Safety run-in: -Css,max -Css,min -Tss,max -Area under the curve -Clearance (inter-compartmental, total, renal fraction) -Volume of distribution (central and peripheral) Randomized controlled trial: 1. The number of BSIs with culture-proven bacteria 2. Results of all positive blood cultures 3. Infection-related (pediatric) intensive care admissions; 4. The number of episodes/admissions with (neutropenic) fever; days with fever (with or without neutropenia), days with FN, Days with neurtopenia 5. Infection-free survival time, i.e., time from diagnosis till first culture-proven BSI; 6. Infection-related mortality; 7. Number of days until neutrophil recovery (ANC of =0.5 x109/L following the nadir); 8. Resistance patterns of pathogenic isolates from blood cultures; 9. Incidence of resistant bacteria in throat and rectal cultures, e.g.,; VRE 10. AEs of special interest; 11. Serious adverse events (SAEs); 12. Use of (other) antibiotics, antifungals and antivirals; 13. Serum creatinine levels 14. Serum teicoplanine levels 15. Cumulative incidence of relapse 16. Event-free survival 17. Overall survival;Timepoint(s) of evaluation of this end point: During and after the safety run-in During the randomized controlled trial

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Countries

Belgium, Denmark, Netherlands, Spain

Contacts

Public ContactHIRUZ

University Hospital Ghent

hiruz.ctu@uzgent.be00309332 09 39

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026