الفهرس | Only 14 pages are availabe for public view |
Abstract Outpatient Management of low-risk fever and neutropenia should be implemented if close monitoring is accessible and patient compliance is feasible. There are not enough studies assessing the tolerance, safety, and efficacy of Amoxicillin/clavulanate plus ciprofloxacin, Levofloxacin, and Moxifloxacin for the treatment of low-risk febrile neutropenia. Objective: In this study, we aimed to assess the safety and efficacy of implementing a clinical pathway using oral antibiotics. We performed randomization between using single-agent Levofloxacin versus Augmentin/Ciprofloxacin regimen used in our institute. Patients and methods: This is a randomized prospective interventional 2-arm study of low-risk febrile neutropenia patients presenting to the emergency department at the National Cancer Institute, Cairo University starting from December 2021 to October 2022. Patients were randomized to double-agent ciprofloxacin and amoxicillinclavulanate compared to a single-agent Levofloxacin. Follow-up of the outpatient cases on Day 1, Day 3, and Day 7. Primary outcomes included: (1) Safe marrow recovery (2) Improvement of fever in all eligible patients. (3) Detecting drug-related side effects encountered in both arms of the study. Results: Two hundred episodes of low-risk febrile neutropenia were enrolled in our trial, one hundred in each arm. On day one, all patients diagnosed as low risk started oral antibiotics and were Instructed about follow-up, compliance, social situation, and alarming signs. On day three, 98% of patients in the levofloxacin arm were afebrile for 24 hours, and 61% in the same arm showed bone marrow recovery. Compared, 83% of afebrile patients in the double agent’s arm and 44 % in the same arm showed recovery counts. One patient was admitted to the ward due to pneumonia on day three. Statistical significance was in favor vi of levofloxacin both in fever defervescence and count recovery with a Pvalue that equals <0.001 and 0.016 respectively. At day five in the levofloxacin receiving arm, 100 patients were afebrile compared to 98 in the double agents receiving arm. One patient was admitted to the ward due to persistent fever in the double agents receiving arm. At day seven, all the study patients were afebrile, had recovery counts, and stopped antibiotics. The recovering counts showed statistical significance in favor of levofloxacin at day 7 with p-value <0.001. This indicates the success of our pathway in detecting and managing low-risk febrile neutropenic patients. Regarding drug-related side effects, 6% of patients in the levofloxacin receiving arm complained of drug-related dyspepsia. Eight percent of the double agent group complained of drug-related diarrhea, and 11% complained of the bad taste of ciprofloxacin. Both were of statistical significance with a p-value of <0.001 for the bad taste and p- value 0.003 for the diarrhea. Conclusion: Implementing a clinical pathway for children with low-risk febrile neutropenia helps in the appropriate management of these patients and decreases hospital costs and the incidence of nosocomial infections. Levofloxacin has better efficacy and can be administered safely in children with low-risk FN. Close follow-up for long-term side effects and monitoring of possible emerging bacterial resistance is warranted following the use of Levofloxacin, especially in settings with a high incidence of MDR bacterial infection. |