SPOG 2015 FN Definition. A Multi-center Non-inferiority Trial on Safety of a High Versus Low Temperature Limit Defining Fever in Pediatric Patients With Cancer at Risk for Fever in Chemotherapy-induced Neutropenia

Swiss Pediatric Oncology Group

Status: Completed

Conditions: Fever; Pediatrics; Neutropenia; Fever in Neutropenia; Cancer

Treatments: Other: 39.0°C temperature limit defining fever; Other: 38.5°C temperature limit defining fever

Study type: Interventional

Funder types: Other

Identifiers

NCT02324231

SPOG 2015 FN Definition

Details and patient eligibility

About

In a multi-center open-label cluster-randomized controlled parallel-group multiple crossover non-inferiority trial in children and adolescents up to 20 years diagnosed with cancer requiring chemotherapy, primarily the safety, and secondarily the efficacy and other endpoints, of a high (39.0°C) versus low (38.5°C) temperature limit defining fever (TLDF) for the diagnosis of fever in chemotherapy-induced neutropenia (FN) is studied. Safety is assessed by the rate of safety relevant events per chemotherapy exposure time, a composite endpoint including serious medical complications and bacteremia during FN. Patients are repeatedly randomized (cluster: study site) to the high or the low TLDF every month, resulting in possible multiple crossovers in one patient. The high TLDF is declared not to be inferior regarding safety compared to the low TLDF if non-inferiority of the rate ratio of safety relevant events is proven, with a single-sided non-inferiority margin of 1.33, applying mixed Poisson regression.

Enrollment: 269 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chemotherapy treatment because of any malignancy for at least 2 months at time of recruitment for myelosuppressive therapy, or at least 1 cycle of myeloablative chemotherapy followed by autologous hematopoietic stem cell transplantation
• Age ≥12 months and <18 years at time of recruitment
• Written informed consent from patients and/or parents

Exclusion criteria

• Infants <1 years old (reason: differences in temperature measurement method)
• Past allogeneic hematopoietic stem cell transplantation
• Denied written informed consent from patients and/or parents

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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269 participants in 2 patient groups

39.0°C temperature limit defining fever

Other group

Description:

Temperature limit defining fever, for definition of fever in neutropenia (FN), is single temperature \>=39.0°C measured in the ear by infrared tympanic thermometry. If clinically indicated, the treating physician is allowed to make the diagnosis of FN at lower temperatures.

Treatment:

Other: 39.0°C temperature limit defining fever

38.5°C temperature limit defining fever

Other group

Description:

Temperature limit defining fever, for definition of fever in neutropenia (FN), is single temperature \>=38.5°C measured in the ear by infrared tympanic thermometry. If clinically indicated, the treating physician is allowed to make the diagnosis of FN at lower temperatures.

Treatment:

Other: 38.5°C temperature limit defining fever