A Single Institution Randomized Clinical Trial Evaluating Ciprofloxacin Versus Levofloxacin As Antibacterial Prophylaxis for Patients Receiving Hematopoietic Stem Cell Transplantation

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Conference Proceeding

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Publication Title

Transplantation and Cellular Therapy


Bacterial infection is a serious complication of stem cell transplantation (SCT). However, the optimal oral agent for prophylaxis is uncertain. A BMTCTN survey by Rashidi et al previously reported the different practice patterns among SCT centers. Different antibiotics might affect incidence of blood stream infections, resistance, Clostridium difficile, gut microbiome, graft versus host disease (GVHD) and relapse differently. To explore this, we started a randomized clinical trial of levofloxacin (Levo) versus ciprofloxacin (Cipro) in SCT pre-engraftment.

Methods: This is a single center prospective randomized study NCT03850379. Patients who meet the SCT program criteria to undergo autologous or allogeneic SCT are eligible. Prophylaxis starts day-2 to engraftment.

Results: Three hundred and seven consecutive patients were randomized between June 2018-May 2022. The median age at time of SCT was 63 years old (20-81), 55.7% males and 44.3% females. Caucasians were 62.5%, African Americans 29.7% and others 7.8%. One hundred and fifty-six (50.8%) patients were assigned to receive Cipro and 151 (49.2%) Levo. The 2 groups were balanced in regard to age, gender, ethnicity, type of SCT, disease type, and conditioning regimen intensity. One hundred and ninety-seven (64.2%) patients had autologous SCT (96 (61.5%) Cipro and 101 (66.9%) Levo) while 110 (35.8%) had allogeneic SCT (60 (38.4%) Cipro and 50 (33.1%) Levo). The time to neutrophil engraftment (median 11 days for both groups, p=0.323) and length of stay post stem cell infusion (median 13 days for both groups, p=0.9164) were not significantly different between the two groups. By day 60 post SCT, 61.2% of all patients developed fever, 11.7% found to have bacteremia and 7.3% pneumonia. In the Cipro group, 20 (12.8%) patients had bacteremia while in the Levo group 16 (10.6%) had bacteremia (p=0.4407). In the Cipro group, 6 (3.8%) patients had Gram negative bacteremia while in the Levo group 9 (6%) had gram negative bacteremia (p=0.39). In the Cipro group, 15 (9.6%) patients had gram positive bacteremia while in the Levo group, 9 (6%) patients had gram positive bacteremia (p=0.23). There were 7 (4.5%) of patients in the Cipro group with Enterococcus faecalis, 3 of which vancomycin resistant, compared to 4 (2.6%) patient in the Levo group, 3 of which vancomycin resistant, (p=0.38). In the Cipro group, 12 (7.7%) had clostridium difficile while in the Levo group 8 (5.3%) had Clostridium difficile (p=0.39). In the cipro group 16 (10.3%) patients developed pneumonia compared to 6 (4%) patients in the Levo group (p=0.0329). There was no difference between the 2 groups in regard to intensive care admissions, relapse, GVHD or death.

Conclusion: In this single center prospective randomized study, Levo prophylaxis was associated with significantly less pneumonia in the first 60 days post-SCT and supports Levo use if prophy is to be used in the peri-transplant period





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