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IL-8 study.


- candidate number10564
- NTR NumberNTR3165
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-nov-2011
- Secondary IDs2005/203 METC UMCG
- Public TitleIL-8 study.
- Scientific TitleRisk-adapted approach for fever and neutropenia in pediatric cancer patients.
- ACRONYMIL-8 study
- hypothesisIt is safe to withhold intravenous broad-spectrum antibiotics in low-risk pediatric cancer patients and to shorten antibiotic treatment in a subgroup of medium-risk pediatric cancer patients presenting with febrile neutropenia.
- Healt Condition(s) or Problem(s) studiedAntibiotics, Pediatric cancer patients, Febrile neutropenia
- Inclusion criteria1. Outpatient cancer patient treated with chemotherapeutic agents;
2. Fever;
3. Neutropenia;
4. Written informed consent;
5. Age less than 18 years.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jun-2006
- planned closingdate31-dec-2012
- Target number of participants270
- InterventionsThe 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 and the neutropenia has recovered. In this study we examine two interventions in order to decrease overtreatment in these children:
1. Withholding antibiotics in low-risk patients (low-risk is defined by having no signs of local bacterial infection and no clinical sepsis at presentation, in combination with two subsequent low values of the biomarker IL-8). The patient is discharged after having been afebrile for at least 12 hours and there is daily phone contact until day 8;
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 negative (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). The patient is discharged and there is daily phone contact until day 8.
- Primary outcome1. 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 defined as a new fever during the first five days of the study period, after having been afebrile for a minimum of 24 hours).

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 experimental arm of the medium-risk group.
- Secondary outcomeIs 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)?
- TimepointsStart study: 01-06-2006;
End study: 31-12-2012.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. W.J.E. Tissing
- CONTACT for SCIENTIFIC QUERIESMD. PhD. W.J.E. Tissing
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Kinderen Kankervrij, Nederland, Stichting ODAS
- PublicationsN/A
- Brief summaryThe long term cancer-free survival of pediatric cancer patients has significantly improved during the past decades due to more intensive chemotherapy treatment regimens. However, these intensive treatment protocols have also resulted in serious treatment related side effects, like life-threatening bacterial infections and sepsis. One of the first (and often only) signs of bacterial infection during chemotherapy induced neutropenia is fever (hereafter called febrile neutropenia). When a patient does develop febrile neutropenia, until recently the standard procedure has been routine hospitalization for administration of intravenous broad-spectrum antibiotics. However, in only 20-40% of these patients a bacterial infection is established. In the remaining patients there is another cause of the fever, like viral of fungal infections,transfusion of blood product, medication like the cytotoxic drugs cytosine-arabinoside (Ara-C) and bleomycin, the malignancy itself or other inflammatory processes like gastro-intestinal mucositis. These causes of neutropenic fever do not need antibiotic treatment. In this national multicenter study we will examine ways to tell which patients are at higher risk to of bacterial infection. We will do this by using a risk assessment model, based on clinical parameters and plasma IL-8 levels. Antibiotics will be withheld when a patient is classified as low risk, while medium and high risk patients will be treated with antibiotics. Medium risk patients will be re-evaluated after 72 hours, and antibiotica will be stopped in this group when 1. blood cultures are negative 2. the patient is afebrile for at least 24 hours and 3. there are no clinical signs of infection/sepsis. We expect to be able to keep 20% of the patients out of the hospital and another 30% shorter in the hospital than nowadays. If this model turns out to be feasible, it will not only lead to an increase of the quality of life for these children and their parents, but also to a substantial reduction of the costs due to decrease in hospital stay and antibiotic treatment duration.
- Main changes (audit trail)
- RECORD22-nov-2011 - 12-dec-2011


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