title: The antimicrobial effect of Iseganan HCl oral solution in patients receiving stomatotoxic chemotherapy: analysis from a multicenter, double-blind, placebo-controlled, randomized, phase III clinical trial.
abstract: BACKGROUND
  Cytotoxic chemotherapy induces changes in the oral microflora that may cause oral and systemic infections in myelosuppressed cancer patients. These complications prompted us to assess the antimicrobial activity of a topical Iseganan HCl mouthwash vs. placebo on the aerobic and facultatively anaerobic oral flora in these patients.
  
  
  METHODS
  Two hundred and twenty-five chemotherapy patients were recruited into a randomized, double-blind, placebo-controlled trial, conducted at multiple centers. The study compared the antimicrobial efficacy of Iseganan HCl vs. placebo (95% of the Iseganan and 97% of the control group received myeloablative chemotherapy). Iseganan HCl 9 mg/3 ml was administered as a swish and swallow solution, six times daily for 21-28 days. Microbial cultures were made before and after the daily Iseganan mouth rinse on the first and final days of chemotherapy.
  
  
  RESULTS
  The reduction in total microbial load after the first day of treatment was statistically significant (1.59 vs. 0.18 log10 CFU for the Iseganan HCl and placebo groups, respectively, P < 0.0001). Iseganan HCl rinse had a cumulative effect demonstrated by the significant difference between the two groups on the last day of the study (i.e. completion of Iseganan daily treatment) (P < 0.05). The reduction was mainly due to decreased densities of viridans streptococci, non-hemolytic streptococci, and yeasts. The minimal inhibitory concentration (MIC) of Iseganan HCl remained the same throughout the course of treatment.
  
  
  CONCLUSIONS
  Topical Iseganan HCl significantly reduces the total oral aerobic bacterial, streptococcal, and yeast load. Its potential as an oral antimicrobial agent in preventing these types of infections is clear.
authors.affiliation: Department of Oral Medicine, Hebrew University-Hadassah School of Dental Medicine, Jerusalem, Israel. sharon.elad@ekmd.huji.ac.il
authors.forename: Sharon
authors.initials: S
authors.lastname: Elad
authors.forename: Joel B
authors.initials: JB
authors.lastname: Epstein
authors.forename: Judith
authors.initials: J
authors.lastname: Raber-Durlacher
authors.forename: Peter
authors.initials: P
authors.lastname: Donnelly
authors.forename: Jacob
authors.initials: J
authors.lastname: Strahilevitz
mesh_terms: D000890:Anti-Infective Agents / Q000627:therapeutic use*; D023181:Antimicrobial Cationic Peptides / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001420:Bacteria, Aerobic / Q000187:drug effects; D001421:Bacteria, Anaerobic / Q000187:drug effects; D058491:Bacterial Load / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006090:Gram-Negative Bacteria / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects* / Q000382:microbiology; D009067:Mouthwashes / Q000627:therapeutic use*; D019653:Myeloablative Agonists / Q000009:adverse effects; D010919:Placebos; D012449:Safety; D013210:Staphylococcus / Q000187:drug effects; D013280:Stomatitis / Q000139:chemically induced / Q000517:prevention & control*; D013291:Streptococcus / Q000187:drug effects; D016896:Treatment Outcome; D034363:Viridans Streptococci / Q000187:drug effects; D015003:Yeasts / Q000187:drug effects
chemical_list: D000890:Anti-Infective Agents; D023181:Antimicrobial Cationic Peptides; D000970:Antineoplastic Agents; D009067:Mouthwashes; D019653:Myeloablative Agonists; D010919:Placebos; C119872:antimicrobial peptide IB-367