Teicoplanin as Infection Prophylaxis in Pediatric Acute Myeloid Leukemia

Safety and efficacy of teicoplanin as infection prophylaxis in pediatric patients with newly-diagnosed acute myeloid leukemia in order to decrease the occurrence of culture-proven Viridans Group Streptococcal sepsis during initial treatment: a prospective, international, multicenter, open-label, randomized clinical trial, preceded by a safety run-in.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29284

Enrollment

130

Registered

2019-11-01

Start date

2021-05-20

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

(Pediatric) Acute myeloid leukemia

Interventions

i.v. teicoplanin prophylaxis 20 mg/kg/once daily three times per week.

Eligibility

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)

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 a severe allergic 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

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the safety run-in is the number of DLTs. The primary endpoint of the randomized phase is the (first) occurrence of a culture-proven BSI with VGS during initial AML treatment.	—

Secondary

Measure	Time frame
Secondary endpoints include the number of BSIs with culture-proven bacteria, the number of infection-related (pediatric) intensive care admissions, the number of episodes/admissions with (neutropenic) fever, infection-free survival time, infection-related mortality, number of days until neutrophil recovery (ANC =0.5 x109/L following the nadir), incidence of resistant bacteria in rectal VRE swabs and in (routine) surveillance throat and rectal swabs, resistance patterns of pathogenic isolates from blood cultures, adverse events (AEs) of special interest (i.e. Grade 3 or 4 increases in serum creatinine, Grade 3 or 4 hearing impairment, Grade 3 or 4 allergic reaction to teicoplanin administration, Grade 3 or 4 sepsis with teicoplanin-resistant organisms, and the occurrence of teicoplanin-resistant organisms in routine surveillance cultures), serious adverse events, data on the use of other (i.v.) antibiotics (empirical/treatment), antifungals and antivirals, PK parameters of teicoplanin, serum creatinine levels, serum levels of teicoplanin and duration of response (time between achieving complete remission after starting study treatment and documented relapse or death), CIR, EFS and OS. Exploratory endpoints include the number of hospitalization days, costs of antibiotics and days on i.v. antibiotics.	—

Measure

Time frame

Secondary endpoints include the number of BSIs with culture-proven bacteria, the number of infection-related (pediatric) intensive care admissions, the number of episodes/admissions with (neutropenic) fever, infection-free survival time, infection-related mortality, number of days until neutrophil recovery (ANC =0.5 x109/L following the nadir), incidence of resistant bacteria in rectal VRE swabs and in (routine) surveillance throat and rectal swabs, resistance patterns of pathogenic isolates from blood cultures, adverse events (AEs) of special interest (i.e. Grade 3 or 4 increases in serum creatinine, Grade 3 or 4 hearing impairment, Grade 3 or 4 allergic reaction to teicoplanin administration, Grade 3 or 4 sepsis with teicoplanin-resistant organisms, and the occurrence of teicoplanin-resistant organisms in routine surveillance cultures), serious adverse events, data on the use of other (i.v.) antibiotics (empirical/treatment), antifungals and antivirals, PK parameters of teicoplanin, serum creatinine levels, serum levels of teicoplanin and duration of response (time between achieving complete remission after starting study treatment and documented relapse or death), CIR, EFS and OS. Exploratory endpoints include the number of hospitalization days, costs of antibiotics and days on i.v. antibiotics.

—

Contacts

Public ContactRomy van Weelderen

Amsterdam University Medical Center, location VUmc

r.vanweelderen@amsterdamumc.nl+31 (0)204445056

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)