Low risk episodes of fever and neutropenia in pediatric oncology: Is outpatient oral antibiotic therapy the new gold standard of care?

Ammann, Roland A.; Simon, Arne; Bont, Eveline S.J.M. de

doi:10.1002/pbc.20287

Cited by 23 publications

(15 citation statements)

References 19 publications

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“…This proportion depends on the underlying malignancy, and the risk of death from infection remains high in some groups, for example, acute myeloid leukemia [4]. Robust risk stratification, which reliably predicted those children at high risk of complications, could target more aggressive management, where children at very low risk of having a significant infection could be treated with reduced intensity and/or duration of hospitalized antibiotic therapy [5]. There are a wide range of differing approaches to this risk stratification, largely built on simple clinical data [6-8], demonstrating only moderate discriminatory ability.…”

Section: Introductionmentioning

confidence: 99%

Systematic review and meta-analysis of the value of initial biomarkers in predicting adverse outcome in febrile neutropenic episodes in children and young people with cancer

Phillips

Wade

Lehrnbecher

et al. 2012

BMC Med

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Background: Febrile neutropenia is a frequently occurring and occasionally life-threatening complication of treatment for childhood cancer. Many biomarkers have been proposed as predictors of adverse events. We aimed to undertake a systematic review and meta-analysis to summarize evidence on the discriminatory ability of initial serum biomarkers of febrile neutropenic episodes in children and young people. Methods: This review was conducted in accordance with the Center for Reviews and Dissemination Methods, using three random effects models to undertake meta-analysis. It was registered with the HTA Registry of systematic reviews, CRD32009100485.

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Section: Introductionmentioning

confidence: 99%

Systematic review and meta-analysis of the value of initial biomarkers in predicting adverse outcome in febrile neutropenic episodes in children and young people with cancer

Phillips

Wade

Lehrnbecher

et al. 2012

BMC Med

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“…For children with FN, however, there is no consensus on when and how to assess the risk of which kind of AE [6][7][8][9]. Correspondingly, there is no consensus on when step-down from standard treatment is safe and efficacious [9].…”

Section: Introductionmentioning

confidence: 99%

First‐day step‐down to oral outpatient treatment versus continued standard treatment in children with cancer and low‐risk fever in neutropenia. A randomized controlled trial within the multicenter SPOG 2003 FN study

Brack

Bodmer

Simon

et al. 2012

Pediatric Blood & Cancer

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BackgroundThe standard treatment of fever in chemotherapy‐induced neutropenia (FN) includes emergency hospitalization and empirical intravenous antimicrobial therapy. This study determined if first‐day step‐down to oral outpatient treatment is not inferior to continued standard regarding safety and efficacy in children with low‐risk FN.ProcedureIn a randomized controlled non‐blinded multicenter study, pediatric patients with FN after non‐myeloablative chemotherapy were reassessed after 8–22 hours of inpatient intravenous antimicrobial therapy. Low‐risk patients were randomized to first‐day step‐down to experimental (outpatient, oral amoxicillin plus ciprofloxacin) versus continued standard treatment. Exact non‐inferiority tests were used for safety (no serious medical complication; non‐inferiority margin of difference, 3.5%) and efficacy (resolution of infection without recurrence, no modification of antimicrobial therapy, no adverse event; 10%).ResultsIn 93 (26%) of 355 potentially eligible FN episodes low‐risk criteria were fulfilled, and 62 were randomized, 28 to experimental (1 lost to follow‐up) and 34 to standard treatment. In intention‐to‐treat analyses, non‐inferiority was not proven for safety [27 of 27 (100%) vs. 33 of 34 (97%; 1 death) episodes; 95% upper confidence border, 6.7%; P = 0.11], but non‐inferiority was proven for efficacy [23 of 27 (85%) vs. 26 of 34 (76%) episodes; 95% upper confidence border, 9.4%; P = 0.045]. Per‐protocol analyses confirmed these results.ConclusionsIn children with low‐risk FN, the efficacy of first‐day step‐down to oral antimicrobial therapy with amoxicillin and ciprofloxacin in an outpatient setting was non‐inferior to continued hospitalization and intravenous antimicrobial therapy. The safety of this procedure, however, was not assessable with sufficient power. Pediatr Blood Cancer 2012;59:423–430. © 2012 Wiley Periodicals, Inc.

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“…When comparing a new method with an established gold-standard, the null hypothesis must be that the new method is inferior [20]. We have been aware, that the limitations in the study design impeded to prove statistical equivalence or non-inferiority.…”

Section: Discussionmentioning

confidence: 97%

“…Among the CVAD-related BSIs in group 2, there were fewer bacteraemias (incidence density, 1.48 vs 0.86), more cases of sepsis (0.49 vs 1.13) and fewer cases of septic shock (0.74 vs 0) and sepsis with multi-organ failure (0.25 vs 0). The mean length of stay in hospital in group 1 before a CVAD-related BSI occurred was 20 …”

Section: Nosocomial Infections and Blood Stream Infectionsmentioning

confidence: 99%

Influence of Prolonged Use of Intravenous Administration Sets in Paediatric Cancer Patients on CVAD-related Bloodstream Infection Rates and Hospital Resources

et al. 2006

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Extending the routine IVAS change-interval from 3 days to 7 days appears to be safe and cost-effective in a paediatric oncology unit with high infection control standards and continuous surveillance for NIs. These results do not prove that 7-day intervals prevent infections, but they do suggest that this policy probably is not harmful and that a prospectively randomized study with sufficient power is needed.

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Low risk episodes of fever and neutropenia in pediatric oncology: Is outpatient oral antibiotic therapy the new gold standard of care?

Cited by 23 publications

References 19 publications

Systematic review and meta-analysis of the value of initial biomarkers in predicting adverse outcome in febrile neutropenic episodes in children and young people with cancer

Systematic review and meta-analysis of the value of initial biomarkers in predicting adverse outcome in febrile neutropenic episodes in children and young people with cancer

First‐day step‐down to oral outpatient treatment versus continued standard treatment in children with cancer and low‐risk fever in neutropenia. A randomized controlled trial within the multicenter SPOG 2003 FN study

Influence of Prolonged Use of Intravenous Administration Sets in Paediatric Cancer Patients on CVAD-related Bloodstream Infection Rates and Hospital Resources

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