A clinical evaluation of efficacy and safety of cefepime monotherapy versus piperacillin-tazobactam in patients of paediatric age group with febrile neutropenia in a tertiary care centre of north India

Mohammad, Aamir; Abrol, Pankaj; Sharma, Deepak; Punia, Harish

doi:10.1177/0049475515617571

Cited by 10 publications

(18 citation statements)

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“…Cefepime was compared to several other antibiotics, including ceftazidime ( 13 – 15 , 17 , 20 ), piperacillin/tazobactam ( 19 , 21 – 24 ), doripenem ( 25 , 26 ), meropenem, cefotaxime ( 27 ), cefozopran ( 28 ), and ceftriaxone-amikacin ( 16 ). Nearly all of the studies had IV as the route of administration with the exception of Aamir et al, which permitted both IV/IM ( 21 ). The dosage, frequency, and duration of both intervention and comparator antibiotics varied throughout the studies.…”

Section: Resultsmentioning

confidence: 99%

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Cefepime Efficacy and Safety in Children: A Systematic Review and Meta-analysis

et al. 2018

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BackgroundCefepime is a fourth-generation cephalosporin antibiotic used to treat a variety of infections. The US Food and Drug Administration approved its use in certain types of infections among pediatric patients, and yet there have been mixed data about its efficacy and safety in this population.ObjectiveThe objective of this review is to compare efficacy and all-cause mortality of cefepime to other clinically indicated antibiotics among children.MethodsWe conducted a systematic search of MEDLINE, EMBASE, CENTRAL, LILACS, and databases through February 8, 2016. We included randomized controlled trials comparing cefepime to other clinical antibiotics, placebo, or no treatment in children aged 0–19 years in the inpatient setting with clinical signs of infection. The primary outcome of interest was all-cause mortality. The secondary outcomes were success rate, treatment failure, and incidence of adverse events. Study quality was assessed using the Cochrane Risk of Bias Assessment Tool.ResultsSeventeen studies met the inclusion criteria. There was a total of 1,285 participants included, 624 participants in the cefepime arm and 661 in the comparison arm. A random effects meta-analysis for all-cause mortality showed no difference in rates of mortality between cefepime and comparator antibiotics with a mortality risk ratio of 0.88 (95% CI: 0.71–1.08). For the secondary outcomes of success rate and treatment failure, a random effects model meta-analysis conducted of the studies showed no difference in rate between cefepime and comparator antibiotics with an overall risk ratio of 0.98 (95% CI: 0.92–1.05) and 1.04 (95% CI: 0.91–1.19), respectively. Adverse events were not statistically assessed given widespread heterogeneity. Overall, the studies had unclear risk of bias and were limited by high heterogeneity and methodological flaws.ConclusionThe efficacy and safety of cefepime in pediatric patients remain unclear despite the inclusion of newer trials since the last index systematic review conducted a decade ago.

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Section: Resultsmentioning

confidence: 99%

“…In four studies, random sequence generation was used in randomization ( 13 , 20 , 21 , 28 ). Aamir et al made use of a computer generated random number for randomization ( 21 ). The study by Kebudi 2001 only reported that “randomization was made using random numbers” ( 20 ).…”

Section: Resultsmentioning

confidence: 99%

Cefepime Efficacy and Safety in Children: A Systematic Review and Meta-analysis

et al. 2018

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“…The review process is presented in Figure 1 . In brief, from the 2847 studies identified through our search, 30 trials fulfilled our inclusion criteria [ 11 , 12 , 19–46 ]. Furthermore, our screening of article references, review articles, and FDA records yielded 2 additional trials [ 47 , 48 ], as well as supplementary data from a previously identified study [ 40 ].…”

Section: Resultsmentioning

confidence: 99%

“…On the contrary, trials that used high-dose (2 grams/8 hours, 50 mg/kg per 8 hours) regimens were not associated with increased mortality in the cefepime arm (RR = 1.387; 95% CI, 0.958–2.008; P = .083 and RR = 1.425; 95% CI, 0.979–2.075; P = .064 for all trials and monotherapy, respectively; 10 trials, 1720 patients) [ 19 , 21–23 , 28 , 34 , 40 , 45 , 47 , 48 ]. It is notable that only 1 study [ 28 ] examined combination therapy, whereas the rest were monotherapy trials.…”

Section: Resultsmentioning

confidence: 99%

“…More importantly, our findings remained unaffected by the inclusion of these unpublished data (RR = 1.337; 95% CI, 0.962–1.859; P = .084 or RR = 1.365; 95% CI, 0.978–1.905; P = .068 for all trials and monotherapy, respectively [Cochrane data [ 9 ]] and RR = 1.313; 95% CI, 0.948–1.818; P = .101 or RR = 1.339; 95% CI, 0.964–1.861; P = .082 for all trials and monotherapy, respectively [FDA data [ 3 ]]). It is notable that 4 of these studies provided data on pediatric patients [ 19 , 34 , 36 , 45 ], and, after excluding pediatric studies from the analysis, the association between high-dose cefepime administration and overall mortality remained nonsignificant (RR = 1.373; 95% CI, 0.973–1.938; P = .072 and RR = 1.405; 95% CI, 0.991–1.992; P = .056 for all trials and monotherapy, respectively). Furthermore, 3 trials that used varying cefepime doses (50 mg/kg every 8–12 hours, 1–2 grams/8 hours, and 1–2 grams/12 hours, respectively [ 25 , 31 , 44 ]) were excluded, because we were unable to ascertain how many patients received high versus low doses.…”

Section: Resultsmentioning

confidence: 99%

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The Dose-Dependent Efficacy of Cefepime in the Empiric Management of Febrile Neutropenia: A Systematic Review and Meta-Analysis

Andreatos

Flokas

Apostolopoulou

et al. 2017

Open Forum Infectious Diseases

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BackgroundDespite reports questioning its efficacy, cefepime remains a first-line option in febrile neutropenia. We aimed to re-evaluate the role of cefepime in this setting.MethodsWe searched the PubMed and EMBASE databases to identify randomized comparisons of (1) cefepime vs alternative monotherapy or (2) cefepime plus aminoglycoside vs alternative monotherapy plus aminoglycoside, published until November 28, 2016.ResultsThirty-two trials, reporting on 5724 patients, were included. Clinical efficacy was similar between study arms (P = .698), but overall mortality was greater among cefepime-treated patients (risk ratio [RR] = 1.321; 95% confidence interval [CI], 1.035–1.686; P = .025). Also of note, this effect seemed to stem from trials using low-dose (2 grams/12 hours, 100 mg/kg per day) cefepime monotherapy (RR = 1.682; 95% CI, 1.038–2.727; P = .035). Cefepime was also associated with increased mortality compared with carbapenems (RR = 1.668; 95% CI, 1.089–2.555; P = .019), a finding possibly influenced by cefepime dose, because carbapenems were compared with low-dose cefepime monotherapy in 5 of 9 trials. Treatment failure in clinically documented infections was also more frequent with cefepime (RR = 1.143; 95% CI, 1.004–1.300; P = .043). Toxicity-related treatment discontinuation was more common among patients that received high-dose cefepime (P = .026), whereas low-dose cefepime monotherapy resulted in fewer adverse events, compared with alternative monotherapy (P = .009).ConclusionsCefepime demonstrated increased mortality compared with carbapenems, reduced efficacy in clinically documented infections, and higher rates of toxicity-related treatment discontinuation. The impact of cefepime dosing on these outcomes is important, because low-dose regimens were associated with lower toxicity at the expense of higher mortality.

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Management of Infections in Neutropenic Patients

Gupta

2020

Benign Hematologic Disorders in Children

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A clinical evaluation of efficacy and safety of cefepime monotherapy versus piperacillin-tazobactam in patients of paediatric age group with febrile neutropenia in a tertiary care centre of north India

Cited by 10 publications

References 18 publications

Cefepime Efficacy and Safety in Children: A Systematic Review and Meta-analysis

Cefepime Efficacy and Safety in Children: A Systematic Review and Meta-analysis

The Dose-Dependent Efficacy of Cefepime in the Empiric Management of Febrile Neutropenia: A Systematic Review and Meta-Analysis

Management of Infections in Neutropenic Patients

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