None listed
Conditions
Interventions
The current treatment strategy for pediatric cancer patients presenting with febrile neutropenia is admission to the hospital and treatment with intravenous antibiotics until the fever has vanished an
2. Shortening antibiotic treatment to 72 hours in a subgroup of medium-risk patients who have been afebrile for at least 24 hours, there are no signs of infection, and blood cultures are still negativ
Sponsors
University Medical Center of Groningen
Hanzeplein 1
9713 GZ Groningen
Eligibility
Inclusion criteria
Inclusion criteria: 1. Outpatient cancer patient treated with chemotherapeutic agents; 2. Fever; 3. Neutropenia; 4. Written informed consent; 5. Age less than 18 years.
Exclusion criteria
Exclusion criteria: 1. Non-neutropenic patients; 2. No informed consent; 3. Recent stem cell transplantation (<1 month); 4. At inclusion use of antibiotics other then for selective gut decontamination, viridans prophylaxis or pneumocystis jiroveci prophylaxis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Is it safe to withhold intravenous broad-spectrum antibiotics in low-risk patients in a multi-center setting (low-risk is defined as having no signs of local infections and clinical sepsis at presentation, in combination with two subsequent low values of the biomarker IL-8 within 24 hours)? Safety is defined as a failure rate of 10% or less in the low-risk group with experimental treatment. Failure in low-risk patients is defined as: I. Classified as low-risk patient whereas the initial blood culture at admission becomes positive; II. Classified as low-risk patient whereas the patient gets relapse fever during on-going neutropenia. (Relapse fever is defined as a new fever during the first five days of the study period, after having been afebrile for a minimum of 24 hours); III. Classified as low-risk patient whereas the patient has persistent fever. One serious adverse event (defined as death of the patient or cardiac and/or respiratory support at the ICU attributable to bacterial infection during the first 5 days after inclusion) is an absolute reason to stop the inclusion in the low-risk group. 2. Is it safe to withhold intravenous broad-spectrum antibiotics in medium-risk patients from day 3 when having been afebrile for at least 24 hours, there are no signs of infection and no positive blood culture 72 hours after admission (medium-risk is defined by having no signs of local bacterial infection and no clinical sepsis at presentation, but at least one high value of the biomarker IL-8). Safety is defined as a failure rate of 10% or less in the medium-risk group with experimental treatment. Failure in medium-risk patients with experimental treatment is described as: I. Classified as medium-risk patient and re-evaluated at day 3 as good risk whereas the initial blood culture at admission became positive after day 3; II. Classified as medium-risk patient and re-evaluated at day 3 as good risk whereas the patient gets relapse fever. (Relapse fever is defin | — |
Secondary
| Measure | Time frame |
|---|---|
| Is it possible to use other markers, e.g. Procalcitonin, to improve the risk assessment for the medium- and high-risk patients (extra blood samples are taken at time of presentation, after 12-24 hours, after 48 hours, and after 72 hours)? | — |
Contacts
Public ContactW.J.E. Tissing
Pediatric Oncologist and Hematologist Hanzeplein 1
Outcome results
None listed