Oral ciprofloxacin vs. intravenous ceftriaxone administered in an outpatient setting for fever and neutropenia in low-risk pediatric oncology patients: Randomized prospective trial

Petrilli, Antônio Sérgio; Dantas, Lenice Silva; Campos, Mônica Cypriano; Tanaka, Cristiana; Ginani, Valeria Cortez; Seber, Adriana

doi:10.1002/(sici)1096-911x(200002)34:2<87::aid-mpo2>3.0.co;2-f

Cited by 109 publications

(28 citation statements)

References 16 publications

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“…The finding that the experimental treatment was non-inferior to continued standard treatment regarding efficacy is in line with results of published RCT on first-day step-down to oral antimicrobial therapy in pediatric low-risk FN, though with different definitions of efficacy [12][13][14][15]. These studies had found no significant difference of efficacy between oral and intravenous antimicrobial therapy, always applied in outpatient settings.…”

Section: Discussionsupporting

confidence: 78%

“…The non-inferiority [20,26,27] tests used here led to more stringent results than the difference tests used in the comparable RCT published [12][13][14][15] and in a recent meta-analysis [16]. This led to positive evidence here that the experimental treatment was non-inferior to the standard treatment regarding efficacy.…”

Section: Discussionmentioning

confidence: 82%

“…These studies had found no significant difference of efficacy between oral and intravenous antimicrobial therapy, always applied in outpatient settings. Oral therapy was used twice from the very beginning [13,15], and twice after step-down from intravenous therapy [12,14]. None of these studies had used a non-inferiority design of analysis, or included a power-analysis.…”

Section: Discussionmentioning

confidence: 99%

“…Intravenous antimicrobial therapy was replaced by a combination of oral ciprofloxacin (25-30 mg/kg/day, top dose 1,500 mg/day, given in 2 daily doses) [13,14,21,22] plus oral amoxicillin (65-80 mg/kg/day, top dose 2,250 mg/day, given in 2 daily doses) [22]. Modification of this therapy was suggested in case of bacteremia known after reassessment, signs and symptoms of a local infection, toxic appearance, or AE/intolerance requiring its discontinuation.…”

Section: Experimental Treatmentmentioning

confidence: 99%

“…In many institutions, stepping-down late, that is, after 2-4 days from presentation with FN, but before resolution of neutropenia, is established for patients with a favorable course of FN [11]. For early or first-day stepping-down from intravenous to oral antimicrobial therapy, four single-center randomized controlled trials (RCT) did not find differences regarding efficacy or safety in low-risk FN [12][13][14][15]. None of these studies nor the corresponding meta-analysis have used a non-inferiority approach, however [16].…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Discussionsupporting

confidence: 78%

Section: Discussionmentioning

confidence: 82%

Section: Discussionmentioning

confidence: 99%

Section: Experimental Treatmentmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

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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Oral versus intravenous antibiotic treatment for febrile neutropenia in cancer patients

Vidal¹,

Dor²,

Pokroy³

et al. 2004

Cochrane Database of Systematic Reviews

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Based on the present data, oral treatment is an acceptable alternative to intravenous antibiotic treatment in febrile neutropenic cancer patients (excluding patients with acute leukaemia) who are haemodynamically stable, without organ failure, not having pneumonia, infection of a central line or a severe soft-tissue infection. The wide confidence interval for mortality allows the present use of oral treatment in groups of patients with an expected low risk for mortality, and further research should be aimed at clarifying the definition of low risk patients.

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Oral versus intravenous antibiotic treatment for febrile neutropenia in cancer patients

Vidal

Dor

Paul

et al. 2013

Cochrane Database of Systematic Reviews

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Based on the present data, oral treatment is an acceptable alternative to intravenous antibiotic treatment in febrile neutropenic cancer patients (excluding patients with acute leukaemia) who are haemodynamically stable, without organ failure, and do not have pneumonia, infection of a central line or a severe soft-tissue infection. The wide CI for mortality allows the present use of oral treatment in groups of patients with an expected low risk for mortality, and further research should be aimed at clarifying the definition of low risk patients.

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Oral ciprofloxacin vs. intravenous ceftriaxone administered in an outpatient setting for fever and neutropenia in low-risk pediatric oncology patients: Randomized prospective trial

Cited by 109 publications

References 16 publications

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

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

Oral versus intravenous antibiotic treatment for febrile neutropenia in cancer patients

Oral versus intravenous antibiotic treatment for febrile neutropenia in cancer patients

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