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CancerNCT02324231

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

A study testing 39.0°C temperature limit defining fever and 38.5°C temperature limit defining fever in people with Cancer and Pediatrics, run by Swiss Pediatric Oncology Group at 6 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 1 year to 18 years
Conditions the study is for
Cancer, Pediatrics, Fever
What is being tested?
39.0°C temperature limit defining fever and 38.5°C temperature limit defining fever
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
6 sitesSwitzerland
Study dates
Apr 2016to 15 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

6 sites in 1 country.

6 sites in 1 country

Switzerland6 sites

  • Basel: Universitätskinderklinik beider Basel

    Basel, CH-4031

  • Bern: Universitätsklinik für Kinderheilkunde, Inselspital

    Bern, CH-3010

  • Geneva: Département de Pédiatrie, Hôpital Cantonal de Genève

    Geneva, CH-1211

  • Lausanne: Hémato-Oncologie Pédiatrique, CHUV

    Lausanne, CH-1011

  • Luzern: Pädiatrische Hämatologie/Onkologie, Kinderspital

    Lucerne, CH-6000

  • Zürich: Pädiatrische Onkologie Kinderspital

    Zurich, CH-8032

Other trials in Switzerland

About this study

Official 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)

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.

Being tested
39.0°C temperature limit defining fever, 38.5°C temperature limit defining fever
Medical subject headings
Neoplasms, Fever, Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 39.0°C temperature limit defining feverOther

    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 feverOther

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

Study groups in NCT02324231
Study groupRoleWhat they receive
39.0°C temperature limit defining feverOtherTemperature 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.
Receives: Other: 39.0°C temperature limit defining fever
38.5°C temperature limit defining feverOtherTemperature 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.
Receives: Other: 38.5°C temperature limit defining fever

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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)

    Measured: 1 year (estimated average)

Secondary outcomes (8)

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

    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)

    Measured: 1 year (estimated average)

  2. Adverse events (B)

    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)

    Measured: 1 year (estimated average)

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

    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)

    Measured: 1 year (estimated average)

  4. Rate of clinically defined FN (D)

    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)

    Measured: 1 year (estimated average)

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

    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)

    Measured: 1 year (estimated average)

  6. Rate of FN diagnosed below TLDF (E)

    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)

    Measured: 1 year (estimated average)

  7. Duration of treatment (F)

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

    Measured: 1 year (estimated average)

  8. Simultaneous and avoided FN diagnoses (G)

    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)

    Measured: 1 year (estimated average)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2014 (estimated)
  2. Study startApr 2016
  3. Primary completion15 Sep 2018
  4. Study completion15 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02324231
Sponsor's protocol ID
SPOG 2015 FN Definition
Status last verified
Oct 2018
First submitted
18 Dec 2014
Last updated
21 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ammann RA. A sequence of Swiss studies on the temperature Limit defining fever in pediatric oncology. Schweizer Krebsbulletin 35(1): 69-71, 2015.

  • Lavieri L, Koenig C, Bodmer N, Agyeman PKA, Scheinemann K, Ansari M, Roessler J, Ammann RA. Predicting fever in neutropenia with safety-relevant events in children undergoing chemotherapy for cancer: The prospective multicenter SPOG 2015 FN Definition Study. Pediatr Blood Cancer. 2021 Dec;68(12):e29253. doi: 10.1002/pbc.29253. Epub 2021 Jul 26.

    PubMed 34310027

  • Koenig C, Bodmer N, Agyeman PKA, Niggli F, Adam C, Ansari M, Eisenreich B, Keller N, Leibundgut K, Nadal D, Roessler J, Scheinemann K, Simon A, Teuffel O, von der Weid NX, Zeller M, Zimmermann K, Ammann RA. 39.0 degrees C versus 38.5 degrees C ear temperature as fever limit in children with neutropenia undergoing chemotherapy for cancer: a multicentre, cluster-randomised, multiple-crossover, non-inferiority trial. Lancet Child Adolesc Health. 2020 Jul;4(7):495-502. doi: 10.1016/S2352-4642(20)30092-4. Epub 2020 Jun 1.

    PubMed 32497520

Questions about this trial

What is this clinical trial studying?

A study testing 39.0°C temperature limit defining fever and 38.5°C temperature limit defining fever in people with Cancer and Pediatrics, run by Swiss Pediatric Oncology Group at 6 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of clinically defined FN with at least one safety relevant event (time frame: 1 year (estimated average)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02324231, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.

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