Efficacy of Ciprofloxacin in Prevention of Sepsis Among the Patients with Chemotherapy-Induced Neutropenia: A Randomized Double-Blind Clinical Trial in a University Hospital in Tehran, Iran

Abstract

Background: Neutropenia is a common side effect of chemotherapy and one of the most common causes of severe infection and mortality in patients with hematological malignancies. Some studies showed that antimicrobial prophylaxis resulted in lower febrile neutropenia (FN) episodes and mortality rates. Objectives: We aimed to determine the efficacy of prophylaxis with ciprofloxacin in patients with hematological malignancies. Methods: In a randomized double-blinded clinical trial from 1 March to 1 September 2016, we assigned patients with chemotherapy-induced neutropenia into two groups. We used the random permuted blocks method for randomization. The first group received oral ciprofloxacin at a dose of 500 milligrams daily until the neutrophil count reached 1000 cells per microliter or fever occurrence, defined as the primary outcome. The second group received a placebo in the same shape and size. We compared FN episodes and the mortality rate in these two groups by SPSS-22 software, using chi-square, Fischer's exact tests, and student t-test at P-value < 0.05. Results: Seventy-three males (60.8%) and 47 females (39.2%) entered our study. The mean age of the patients was 47 ± 14.6 years. Acute leukemia was the most common underlying malignancy in 81 out of 120 subjects (67.5%). Fever (P = 0.005) was significantly lower in the ciprofloxacin group, but the mortality rate (P = 0.783) did not differ between the two groups. Conclusions: We found that the prophylaxis with ciprofloxacin decreased FN in our patients but did not influence the mortality rate. We believe that antimicrobial prophylaxis may be helpful in neutropenic patients, especially in decreasing FN and its related comorbidity.