title: Efficacy and safety of moxifloxacin as antibacterial prophylaxis for patients receiving autologous haematopoietic stem cell transplantation: a randomised trial.
abstract: Patients receiving high-dose chemotherapy with autologous peripheral blood stem cell transplantation (PBSCT) are at high risk of infections, especially bacteraemia. A prospective, double-blind, randomised, placebo-controlled, single-centre, pilot study was performed on oral moxifloxacin 400mg versus placebo for preventing bacteraemia in PBSCT recipients. Patients received moxifloxacin or placebo for the duration of neutropenia or until emergence of fever or other infections necessitating intravenous antibiotic treatment. Of 68 patients included in the trial, 2 were excluded from the trial before taking their first dose. The remaining 66 patients were eligible for evaluation in the intention-to-treat analysis set. Neutropenia with an absolute neutrophil count of <500cells/μL developed in 30 moxifloxacin-treated patients (88.2%) and 21 patients in the placebo group (65.6%) (P<0.03). Nine patients (26.5%) and eight patients (25.0%), respectively, were prematurely discontinued from study treatment. Breakthrough bacteraemia occurred in 3 moxifloxacin-treated patients (8.8%) and 9 patients in the placebo group (28.1%) (P=0.042). The time period until fever was 9.5 days [95% confidence interval (CI) 8.06-10.94 days) and 7.69 days (95% CI 6.51-8.85 days), respectively (P=0.0499). There was no difference in adverse events or toxicities between the groups. Moxifloxacin prevented bacteraemia and shortened febrile episodes in patients receiving autologous PBSCT. No significant increase of adverse events in the moxifloxacin arm was observed, possibly due to the rather small sample size.
authors.affiliation: Department I for Internal Medicine, University Hospital of Cologne, Cologne, Germany. janne.vehreschild@ctuc.de
authors.forename: J Janne
authors.initials: JJ
authors.lastname: Vehreschild
authors.forename: Gregor
authors.initials: G
authors.lastname: Moritz
authors.forename: Maria J G T
authors.initials: MJ
authors.lastname: Vehreschild
authors.forename: Dorothee
authors.initials: D
authors.lastname: Arenz
authors.forename: Martina
authors.initials: M
authors.lastname: Mahne
authors.forename: Henning
authors.initials: H
authors.lastname: Bredenfeld
authors.forename: Jens
authors.initials: J
authors.lastname: Chemnitz
authors.forename: Florian
authors.initials: F
authors.lastname: Klein
authors.forename: Birgit
authors.initials: B
authors.lastname: Cremer
authors.forename: Boris
authors.initials: B
authors.lastname: Böll
authors.forename: Ingrid
authors.initials: I
authors.lastname: Kaul
authors.forename: Gernot
authors.initials: G
authors.lastname: Wassmer
authors.forename: Michael
authors.initials: M
authors.lastname: Hallek
authors.forename: Christof
authors.initials: C
authors.lastname: Scheid
authors.forename: Oliver A
authors.initials: OA
authors.lastname: Cornely
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects; D019072:Antibiotic Prophylaxis / Q000009:adverse effects* / Q000379:methods*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D001372:Aza Compounds / Q000008:administration & dosage* / Q000009:adverse effects*; D016470:Bacteremia / Q000517:prevention & control; D001424:Bacterial Infections / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D009503:Neutropenia / Q000150:complications; D010865:Pilot Projects; D010919:Placebos / Q000008:administration & dosage; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects*; D033581:Stem Cell Transplantation; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D000970:Antineoplastic Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D010919:Placebos; D011804:Quinolines; D000077266:Moxifloxacin