Prospective Randomized Study of Prophylactic Ciprofloxacin Versus Levofloxacin in Hematopoietic Stem Cell Transplant Patients: An Interim Report
Abstract
Infection is a serious complication of hematopoietic stem cell transplantation (SCT). However, the optimum oral agent for antibacterial prophylaxis in SCT recipients remains uncertain. Different antibiotics might affect incidence of blood stream infections, resistance, Clostridium difficile, gut microbiome, GVHD and relapse. To explore this we started this first clinical trial of levofloxacin (Levo) versus ciprofloxacin (Cipro) at our center. Methods: This is a single center prospective randomized study. Patients who meet the SCT program criteria to undergo autologous or allogeneic hematopoietic stem cell transplantation are eligible. Results: We present interim results. 111 consecutive patients were randomized since June 2018. At the time of the present report 102 of these patients have follow up for 60 days or more. There were 62 males and 40 females. Median age at time of SCT was 61. Fifty received Cipro and 52 received Levo. Fifty-six patients had autologous (27 Cipro and 29 Levo) while 46 patients had allogeneic SCT (23 Cipro and 23 Levo). For allogeneic SCT, 12 patients in each group had ATG. Time to engraftment and length of stay were similar in both groups. In the Cipro group 6 patients (12%) had bacteremia while in the Levo group 7 (13%) had bacteremia. Of patients with bacteremia, in the Cipro group none had Gram negative bacteremia while in the Levo group 4 had gram negative bacteremia (OR 9.37, p = 0.137). In the Cipro group 6 patients had gram positive…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 111 participants or records.
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