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| ID | Type | Description | Link |
|---|---|---|---|
| KFS-2933-02-2012 | Other Grant/Funding Number | Krebsforschung Schweiz |
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| Name | Class |
|---|---|
| Swiss Cancer League | OTHER |
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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
HYPOTHESIS In children and adolescents with cancer, hypothetically modifying the definitions of fever from ear temperature 39.0°C to lower limits would
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Pediatric patients with cancer, receiving standard chemotherapy, and receiving standard supportive therapy in case of fever in neutropenia (FN) (No intervention for study purposes) |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate ratio of additional episodes of FN diagnosed (applying LimitLow vs. LimitStandard) | until 2 weeks after last dose of chemotherapy (expected median, 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of episodes of fever | (Protocol: 1) | until 2 weeks after last dose of chemotherapy (expected median, 6 months) |
| Rate of emergency calls for fever | (Protocol: 2a) |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Roland A Ammann, MD | Pediatric Hematology/Oncology, Department of Pediatrics, University of Bern, Bern, Switzerland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Hematology/Oncology, Department of Pediatrics, University of Bern / Inselspital | Bern | CH-3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25671574 | Result | 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. | |
| 29462193 | Result | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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1 mL serum, kept refrigerated until the end of study, then analyed as batch for cortisol, then discarded.
| until 2 weeks after last dose of chemotherapy (expected median, 6 months) |
| Rate ratio of FN diagnosed earlier (applying LimitLow vs. LimitStandard) | (Protocol: 3) | until 2 weeks after last dose of chemotherapy (expected median, 6 months) |
| Proportion of FN with blood cultures performed after start of antibiotics (AB) for prolonged fever | (Protocol: 4a) | until end of AB therapy for FN (estimated median, 4 days) |
| 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.) | until end of AB therapy for FN (estimated median, 4 days) |
| Time point of empirical AB switch for prolonged fever during FN | (Protocol: 6a) | until end of AB therapy for FN (estimated median, 4 days) |
| Proportion of FN with any adverse event | (Protocol: 7a) | until end of AB therapy for FN (estimated median, 4 days) |
| Serum level of cortisol | (Protocol: 8) | at presentation with FN (in reality) |
| Proportion of FN with switch of empirical AB for prolonged fever | (Protocol: 4b) | until end of AB therapy for FN (estimated median, 4 days) |
| Proportion of FN with add-on of empirical antifungal therapy for prolonged fever | (Protocol: 4c) | until end of AB therapy for FN (estimated median, 4 days) |
| Rate of emergency CBC with consultation for fever | (Protocol: 2b) | until 2 weeks after last dose of chemotherapy (expected median, 6 months) |
| Time point of starting empirical antifungal therapy for prolonged fever during FN | (Protocol: 6b) | until end of AB therapy for FN (estimated median, 4 days) |
| Proportion of FN with bacteremia | (Protocol: 7b) | until end of AB therapy for FN (estimated median, 4 days) |
| Proportion of FN with serious medical complication | (Protocol: 7c) | until end of AB therapy for FN (estimated median, 4 days) |
| 32457478 | Result | 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. |
| 31270328 | Result | 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. |