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Cancer in Children/AdolescentsNCT01683370

Pediatric FN Definition 2012 Bern

An observational study of Cancer in Children/Adolescents and Fever in Neutropenia, run by Dr. Roland Ammann at 1 site 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

STUDY AIMS Based on prospectively collected information on ear temperatures, ANC values, emergency calls and consultations for fever, and on hospitalizations for FN in children and adolescents with cancer to describe the frequency of episodes of FN, and of other clinically relevant FN-related measures to compare these… Read more about this study

Who is it for?
Ages 1 year to 17 years
How many people
39 participants
Where
1 siteSwitzerland
Study dates
Aug 2012to Aug 2013
Phase
Observational
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 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Pediatric patients diagnosed with cancer requiring chemotherapy, treated at the Division of Pediatric Hematology/Oncology, Department of Pediatric, University of Bern / Inselspital, CH-3010 Bern, Switzerland

Who may be able to join

  • >1 year and ≤17 years at time of recruitment
  • Chemotherapy treatment because of any malignancy for at least 2 months at time of recruitment
  • Written informed consent from patients and/or parents for the study

Who cannot join

  • Infants ≤1 year old (reason: differences in standard fever limit and method to measure temperature)
  • Denied written informed consent from patients and/or parents for the study

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Division of Hematology/Oncology, Department of Pediatrics, University of Bern / Inselspital

    Bern, CH-3010

Other trials in Switzerland

About this study

Official title: Pediatric FN Definition 2012 Bern The Impact of Lowering Fever Limits on the Rate of Fever in Chemotherapy-induced Neutropenia (FN). A Prospective Single-center Observational Study in Children and Adolescents With Cancer.

STUDY AIMS Based on prospectively collected information on ear temperatures, ANC values, emergency calls and consultations for fever, and on hospitalizations for FN in children and adolescents with cancer

  • to describe the frequency of episodes of FN, and of other clinically relevant FN-related measures
  • to compare these frequencies and measures in reality vs. applying Bernese standard limits for defining fever (ear temperature ≥39.0°C)
  • to compare these frequencies and measures applying the Bernese standard limit of ≥39.0°C (LimitStandard) vs. a range of hypothetically lower limits defining fever (LimitLow)
  • to determine if it would be useful to perform an interventional study on the question of different fever limits, powered to study both efficacy (frequency of FN) and safety (AE in delayed FN diagnosis)
  • to use the platform of this prospective study to explore if the serum level of cortisol is associated with adverse events in FN
Read more

HYPOTHESIS In children and adolescents with cancer, hypothetically modifying the definitions of fever from ear temperature 39.0°C to lower limits would

  • increase the rate of FN episodes diagnosed during chemotherapy (primary endpoint).
  • increase the rate of other clinically important FN-related measures related to chemotherapy exposure time (secondary endpoints 1,2,3) and outcome/treatment-related measures during treatment of FN episodes diagnosed in reality (secondary endpoints 4,5,6).
  • not relevantly decrease the proportion of FN with AE (secondary endpoint 7).
Medical subject headings
Neoplasms

What participants receive

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

Study groups in NCT01683370
Study groupRoleWhat they receive
PatientsPediatric patients with cancer, receiving standard chemotherapy, and receiving standard supportive therapy in case of fever in neutropenia (FN) (No intervention for study purposes)

What is being measured

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

  1. Rate ratio of additional episodes of FN diagnosed (applying LimitLow vs. LimitStandard)

    Measured: until 2 weeks after last dose of chemotherapy (expected median, 6 months)

Secondary outcomes (14)

  1. Rate of episodes of fever

    (Protocol: 1)

    Measured: until 2 weeks after last dose of chemotherapy (expected median, 6 months)

  2. Rate of emergency calls for fever

    (Protocol: 2a)

    Measured: until 2 weeks after last dose of chemotherapy (expected median, 6 months)

  3. Rate ratio of FN diagnosed earlier (applying LimitLow vs. LimitStandard)

    (Protocol: 3)

    Measured: until 2 weeks after last dose of chemotherapy (expected median, 6 months)

  4. Proportion of FN with blood cultures performed after start of antibiotics (AB) for prolonged fever

    (Protocol: 4a)

    Measured: until end of AB therapy for FN (estimated median, 4 days)

  5. Proportion of FN with delayed hospital discharge for prolonged fever

    (Protocol: 5) (Low risk FN episodes with first-day stepping down will be excluded from this analysis.)

    Measured: until end of AB therapy for FN (estimated median, 4 days)

  6. Time point of empirical AB switch for prolonged fever during FN

    (Protocol: 6a)

    Measured: until end of AB therapy for FN (estimated median, 4 days)

  7. Proportion of FN with any adverse event

    (Protocol: 7a)

    Measured: until end of AB therapy for FN (estimated median, 4 days)

  8. Serum level of cortisol

    (Protocol: 8)

    Measured: at presentation with FN (in reality)

  9. Proportion of FN with switch of empirical AB for prolonged fever

    (Protocol: 4b)

    Measured: until end of AB therapy for FN (estimated median, 4 days)

  10. Proportion of FN with add-on of empirical antifungal therapy for prolonged fever

    (Protocol: 4c)

    Measured: until end of AB therapy for FN (estimated median, 4 days)

  11. Rate of emergency CBC with consultation for fever

    (Protocol: 2b)

    Measured: until 2 weeks after last dose of chemotherapy (expected median, 6 months)

  12. Time point of starting empirical antifungal therapy for prolonged fever during FN

    (Protocol: 6b)

    Measured: until end of AB therapy for FN (estimated median, 4 days)

  13. Proportion of FN with bacteremia

    (Protocol: 7b)

    Measured: until end of AB therapy for FN (estimated median, 4 days)

  14. Proportion of FN with serious medical complication

    (Protocol: 7c)

    Measured: until end of AB therapy for FN (estimated median, 4 days)

Timeline

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

  1. First posted11 Sep 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01683370
Sponsor's protocol ID
PFND2012B
Other IDs
KFS-2933-02-2012
Status last verified
Oct 2020
First submitted
31 Aug 2012
Last updated
2 Nov 2020
Results posted
No
Data monitoring committee
No

Publications

  • Ammann RA, Teuffel O, Agyeman P, Amport N, Leibundgut K. The influence of different fever definitions on the rate of fever in neutropenia diagnosed in children with cancer. PLoS One. 2015 Feb 11;10(2):e0117528. doi: 10.1371/journal.pone.0117528. eCollection 2015.

    PubMed 25671574

  • Wagner S, Brack EK, Stutz-Grunder E, Agyeman P, Leibundgut K, Teuffel O, Ammann RA. The influence of different fever definitions on diagnostics and treatment after diagnosis of fever in chemotherapy-induced neutropenia in children with cancer. PLoS One. 2018 Feb 20;13(2):e0193227. doi: 10.1371/journal.pone.0193227. eCollection 2018.

    PubMed 29462193

  • Brack E, Wagner S, Stutz-Grunder E, Agyeman PKA, Ammann RA. Temperatures, diagnostics and treatment in pediatric cancer patients with fever in neutropenia, NCT01683370. Sci Data. 2020 May 26;7(1):156. doi: 10.1038/s41597-020-0504-9.

    PubMed 32457478

  • Lavieri L, Koenig C, Teuffel O, Agyeman P, Ammann RA. Temperatures and blood counts in pediatric patients treated with chemotherapy for cancer, NCT01683370. Sci Data. 2019 Jul 3;6(1):108. doi: 10.1038/s41597-019-0112-8.

    PubMed 31270328

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer in Children/Adolescents and Fever in Neutropenia, run by Dr. Roland Ammann at 1 site 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 2 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 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 ratio of additional episodes of FN diagnosed (applying LimitLow vs. LimitStandard) (time frame: until 2 weeks after last dose of chemotherapy (expected median, 6 months)). 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 NCT01683370, which also lists 4 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 2 Nov 2020.

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