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NCT Number: NCT02324231

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

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.

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Key information

Conditions

Cancer Agranulocytosis Body Temperature Changes Cytopenia Fever Fever in Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neoplasms Neutropenia Pathological Conditions, Signs and Symptoms Pediatrics Signs and Symptoms

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Basel: Universitätskinderklinik beider Basel, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

39.0°C temperature limit defining fever

Other

Diagnosis of FN, correspondingly hospitalization and start of empirical intravenous broad-spectrum antimicrobial therapy. Further treatment according to treating physician.

38.5°C temperature limit defining fever

Other

Diagnosis of FN, correspondingly hospitalization and start of empirical intravenous broad-spectrum antimicrobial therapy. Further treatment according to treating physician.

Primary outcomes

  1. Rate of clinically defined FN with at least one safety relevant event

    Time frame: 1 year (estimated average)

    Poisson rate: number of clinically defined FN with at least one SRE divided by the entire chemotherapy exposure time for each patient, estimated to be 1 year on average (Unit: FN per year of chemotherapy exposure time) SRE: Composite endpoint (serious medical complication AND/OR bacteremia), reached until the end of each individual FN episode (Unit: binary)

Secondary outcomes

  1. Times and delays of diagnosis and therapy (A)

    Time frame: 1 year (estimated average)

    Times (hh:mm) of measurement of fever - telephone to study site - arrival at emergency department - prescription of antibiotics - start and end of first dose of i.v. antibiotics (assessed per FN episode by the responsible local PHO and in patient chart, reported per FN episode; unit: hours:minutes)

  2. Adverse events (B)

    Time frame: 1 year (estimated average)

    AE: clinically / microbiologically documented infection, unexplained fever, sepsis / severe sepsis / septic shock, relapse of primary infection (assessed in patient charts, reported per FN; unit:binary)

  3. Delay from crossing low to high TLDF (C)

    Time frame: 1 year (estimated average)

    Only for currently active high TLDF: delay time between crossing low and high TLDF; delayed FN diagnosis (see 5.1.4) by high vs. low TLDF (assessed from patients charts, reported per FN; unit: hours:minutes)

  4. Rate of clinically defined FN (D)

    Time frame: 1 year (estimated average)

    Poisson rate: number of clinically defined FN divided by the entire chemotherapy exposure time for each patient, estimated to be 1 year on average (Unit: FN per year of chemotherapy exposure time)

  5. Rate of FN diagnosed at/above TLDF (E)

    Time frame: 1 year (estimated average)

    Poisson rate: number of FN diagnosed at/above TLDF divided by the entire chemotherapy exposure time for each patient, estimated to be 1 year on average (Unit: FN per year of chemotherapy exposure time)

  6. Rate of FN diagnosed below TLDF (E)

    Time frame: 1 year (estimated average)

    Poisson rate: number of FN diagnosed below TLDF divided by the entire chemotherapy exposure time for each patient, estimated to be 1 year on average (Unit: FN per year of chemotherapy exposure time)

  7. Duration of treatment (F)

    Time frame: 1 year (estimated average)

    . Duration of hospitalization, ICU treatment, i.v. antibiotics, p.o. antibiotics, any antibiotics, delay of chemotherapy for FN (unit: days)

  8. Simultaneous and avoided FN diagnoses (G)

    Time frame: 1 year (estimated average)

    Only for currently active high TLDF: Simultaneous and avoided FN diagnoses by high vs. low TLDF (assessed from patients charts, reported per FN; unit: binary)

Other outcomes

  1. Development of rules predicting risk of FN during chemotherapy

    Time frame: 1 year (estimated average)

    Risk prediction rules for clinically defined FN, clinically defined FN with bacteremia, with serious medical complication, and with safety relevant event during chemotherapy, all based on multivariate mixed Poisson regression (stepwise forward variable selection procedure; unit: predictor)

  2. Development of rules predicting risk of adverse events during FN

    Time frame: 1 year (estimated average)

    Risk prediction rules for bacteremia, for serious medical complication, and for safety relevant event during FN, all based on multivariate mixed logistic regression (stepwise forward variable selection procedure; unit: predictor)

  3. External validation of rules predicting risk of FN during chemotherapy

    Time frame: 1 year (estimated average)

    Validation of published risk prediction rules for clinically defined FN, clinically defined FN with bacteremia, with serious medical complication, and with safety relevant event during chemotherapy (units: sensitivity, specificity, positive and negative predictive value, area under receiver operating characteristic curve)

  4. External validation of rules predicting risk of adverse events during FN

    Time frame: 1 year (estimated average)

    Validation of published risk prediction rules for bacteremia, for serious medical complication, and for safety relevant event during FN (units: sensitivity, specificity, positive and negative predictive value, area under receiver operating characteristic curve)

Sponsors and collaborators

Lead sponsor

Swiss Pediatric Oncology Group

Other

Registry information

Official study title

SPOG 2015 FN Definition. A Swiss Pediatric Oncology Group (SPOG) Initiated Multi-center Open-label Randomized Controlled Multiple Crossover 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 (FN)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 24, 2014
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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