Background: Meropenem (MEPM) is widely used for treatment of febrile neutropenia. There have been many reports on MEPM for pediatric febrile neutropenia showing success rates of approximately 50‐75%. Although i.v. immuno‐globulin (IVIG) is widely used for treatment of infection with antibiotics, there has been no report on the efficacy of IVIG for pediatric febrile neutropenia. This prospective randomized study was therefore carried out to clarify the usefulness of MEPM with or without IVIG as second line‐therapy for pediatric febrile neutropenia. Methods: A total of 61 pediatric patients with 146 episodes were judged to have failure of first‐line therapy (August 2008‐April 2010: cefozopran vs cefepime; April 2010‐April 2012: cefepime vs piperacillin/tazobactam) for febrile neutropenia, and were randomized to MEPM and MEPM + IVIG groups. Results: MEPM with or without IVIG as second‐line therapy was effective in 68.1% of a total of 144 episodes. Success rates in the MEPM and MEPM + IVIG groups were 66.3% and 70.5%, respectively. Furthermore, success rates for patients with IgG <500 mg/dL were 62.5% in the MEPM group and 81.3% in the MEPM + IVIG group. This result, however, was not statistically significant, possibly because of the small sample size. Conclusions: MEPM is effective and safe for second‐line treatment of febrile episodes in neutropenic pediatric patients. Moreover, IVIG is effective for patients with low serum IgG.
BACKGROUND: Febrile neutropenia (FN) is a common and serious complication of cancer chemotherapy associated with significant morbidity and mortality. Cefozopran (CZOP) is a potential candidate for empirical monotherapy in FN. However, studies on the use of CZOP as empirical treatment for pediatric patients with FN are quite limited. The purpose of this study was to compare the efficacy and safety of CZOP with cefepime (CFPM) empirical monotherapy in pediatric cancer patients with FN.
PROCEDURES: A total of 64 patients with 224 episodes of FN were randomly assigned to receive antibiotic therapy with either CZOP (100 mg/kg/day) or CFPM (100 mg/kg/day). Of these episodes, 223 were considered eligible for the study. Success was defined as resolution of febrile episodes and clinical signs of infection within 120 hr following the start of antibiotic therapy.
RESULTS: The success rate was not significantly different between the CZOP (64.0%) and CFPM (56.3%) groups (P = 0.275). Duration of fever, duration of antibiotic therapy, and the success rate in patients with blood stream infection did not differ between the two groups. There was no infection-related mortality in the study period.
CONCLUSION: Both CZOP and CFPM as monotherapy appear to be effective and safe in pediatric patients. This study suggests that CZOP has satisfactory efficacy and is well tolerated as initial empirical therapy for pediatric cancer patients with FN.
BACKGROUND: Febrile neutropenia (FN) is a frequent, serious complication of intensive pediatric chemotherapy regimens. The aim of this trial was to compare quality of life (QOL) between inpatient and outpatient intravenous antibiotic management of children and adolescents with low risk febrile neutropenia (LRFN).
PROCEDURE: In this randomised non-blinded trial, patients between 1 and 21 years old, receiving low/moderate intensity chemotherapy were pre-consented and, on presentation to emergency (ED) with FN satisfying low risk criteria, randomised to either outpatient or inpatient care with intravenous cefepime 50 mg/kg (12 hourly). All patients continued antibiotics for at least 48 hours, until afebrile for 24 hours and demonstrating a rising absolute neutrophil count ≥200/mm(3). Several domains of QOL were examined by daily questionnaire.
RESULTS: Eighty-one patients presented to ED with 159 episodes of fever. Thirty-seven FN presentations involving 27 patients were randomised to inpatient (18) and outpatient (19) management. Combined QOL mean scores for parents were higher for the outpatient group and scores for three specific parent variables (keeping up with household tasks/time spent with partner/time spent with other children) were higher among outpatients. There was no difference in parent confidence/satisfaction in care between groups. Patients scored better in the outpatient group overall and for sleep and appetite. The mean length of fever was equivalent between groups and there were no serious adverse events attributable to cefepime or outpatient care.
CONCLUSION: Outpatient cefepime management of LRFN provided significant benefit to parents and patients across several QOL domains and appeared both feasible and safe.
The objective of this study was to compare the effectiveness of piperacillin-tazobactam (PIP/TAZO) plus amikacin (AMK) (PIP/TAZO+AMK) versus cefoperazone-sulbactam (CS) plus AMK (CS+AMK) for the treatment of febrile neutropenia (FN) in children with cancer. The study was designed prospectively and randomized in 0- to 18-year-old children with lymphoma or solid tumor who were hospitalized with FN diagnosis. Consecutively randomized patients received either PIP/TAZO 360 mg/kg/day in 4 doses plus AMK 15 mg/kg/day in 3 doses or CS 100 mg/kg/day in 3 doses plus AMK 15 mg/kg/day in 3 doses intravenously. Treatment modification was defined as any change in the initial empirical antibiotic therapy. A total of 116 FN episodes were managed in 46 patients (26 boys and 20 girls) with a median age of 6.5 years (range .8-17.0) during the study period. Success rates without modification of therapy were 47.5% and 52.6% in PIP/TAZO+AMK group and CS+AMK group, respectively (P >.05). No statistical difference was found between treatment groups in terms of durations of neutropenia, fever, and hospitalization. The overall success rate in all groups was 97.4%. No major side effect was observed in either group during the course of the study. Our study is the first to compare the effectiveness of PIP/TAZO+AMK and CS+AMK therapies. Both combinations were effective and safe as empirical therapy for febrile neutropenic patients.
BACKGROUND: In cancer patients, various infections were developed due to severe neutropenia resulted from chemotherapy. Ceftazidime is commonly used as monotherapy of cancer patients with fever and neutropenia. Meropenem is a new carbapenem with more extended antibacterial spectrum including anaerobes. It provides better coverage against gram positives. This trial compared the efficacy and safety of meropenem with ceftazidime as empirical monotherapy for febrile neutropenia in pediatric patients with cancer.
MATERIALS AND METHODS: A prospective, double-blind, randomized clinical trial was conducted at Departments of Pediatric Haematology/Oncology, University Hospitals, Yazd, Iran, during the years 2012 to 2013. A total of 48 cancer patients participated in the trial.
RESULT: In this study, 26 patients (54.16%) were treated by ceftazidime and 22 patients (45.84%) by meropenem. Mean duration of fever in those who responded to treatment in ceftazidime group was 19.43+/-31.04 hours, and in meropenem group was 16.53+/-28.77 hours (P-value = 0.965).
CONCLUSION: Finding of this study indicate that ceftazidime and meropenem have similar efficacy in treatment of fever and sever neutropenia. Due to more availability and lower cost of ceftazidime than meropenem, ceftazidime is suggested as a first line treatment in fever and neutropenia.
BACKGROUND: Monotherapy has tended to replace the combination therapy in emprical treatment of febrile neutropenia. There is no reported trial which compares the efficacy of cefoperazone-sulbactam (CS) and piperacillin-tazobactam (PIP/TAZO) monotherapies in the treatment of febrile neutropenia. In this prospective randomized study, we aimed to compare the safety and efficacy of CS versus PIP/TAZO as empirical monotherapies in febrile neutropenic children with cancer.
PROCEDURE: The study included febrile, neutropenic children hospitalized at our center for cancer. They were randomly selected to receive CS 100 mg/kg/day or PIP/TAZO 360 mg/kg/day. Duration of fever and neutropenia, absolute neutrophil count, modification, and success rate were compared between the two groups. Resolution of fever without antibiotic change was defined as success and resolution of fever with antibiotic change or death of a patient was defined as failure. Modification was defined as changing the empirical antimicrobial agent during a febrile episode.
RESULTS: One hundred and two febrile neutropenic episodes were documented in 55 patients with a median age of 4 years. In 50 episodes CS and in 52 episodes PIP/TAZO was used. Duration of fever and neutropenia, neutrophil count, age, sex, and primary disease were not different between two groups. Success rates in the CS and PIP/TAZO groups were respectively 56 and 62% (P > 0.05). Modification rate between two groups showed no significant difference (P > 0.05). No serious adverse effect occurred in either of the groups.
CONCLUSION: CS and PIP/TAZO monotherapy are both safe and effective in the initial treatment of febrile neutropenia in children with cancer.
Given that the rationale for empirical antifungal therapy in neutropenic children is limited and based on adult patient data, we performed a prospective, randomized, controlled trial that evaluated 110 neutropenic children with persistent fever. Those at high risk for invasive fungal infections (IFI) received caspofungin (Arm C) or liposomal amphotericinB (Arm B); those with a lower risk were randomized to receive Arm B, C, or no antifungal treatment (Arm A). Complete response to empirical antifungal therapy was achieved in 90/104 patients (86·5%): 48/56 at high risk (85·7%) [88·0% in Arm B; 83·9% in Arm C (P = 0·72)], and 42/48 at low risk (87·5%) [87·5% in control Arm A, 80·0% Arm B, 94·1% Arm C; (P = 0·41)]. None of the variables tested by multiple logistic regression analysis showed a significant effect on the probability to achieve complete response. IFI was diagnosed in nine patients (8·2%, 95% confidence interval, 3·8-15·0). This randomized controlled study showed that empirical antifungal therapy was of no advantage in terms of survival without fever and IFI in patients aged <18 years and defined with low risk of IFI. Higher risk patients, including those with relapsed cancer, appear to be the target for empirical antifungal therapy during protracted febrile neutropenia.
