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

Journal of Oral Pathology and Medicine

Volumn 41, Issue 3, 2012, Pages 229-234

  Elad, Sharon ^a,b   Epstein, Joel B ^c   Raber Durlacher, Judith ^d   Donnelly, Peter ^e   Strahilevitz, Jacob ^f  

^a HEBREW UNIVERSITY OF JERUSALEM   (Israel)

^b UNIVERSITY OF ROCHESTER   (United States)

^c UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^d LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^e RADBOUD UNIVERSITY NIJMEGEN   (Netherlands)

^f HADASSAH HEBREW UNIVERSITY MEDICAL CENTER   (Israel)

Author keywords

Antifungal; Antimicrobial; Isegenan; Oral; Topical

Indexed keywords

ISEGANAN; MOUTHWASH; PLACEBO;

ADULT; AEROBIC BACTERIUM; ALPHA HEMOLYTIC STREPTOCOCCUS; ANTIMICROBIAL ACTIVITY; ARTICLE; BACTERIUM CULTURE; CHEMOTHERAPY; COLONY FORMING UNIT; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; FEMALE; HEMOLYTIC STREPTOCOCCUS; HUMAN; MAJOR CLINICAL STUDY; MALE; MINIMUM INHIBITORY CONCENTRATION; MOUTH FLORA; MULTICENTER STUDY; MYELOABLATIVE CONDITIONING; NON HEMOLYTIC STREPTOCOCCI; PATHOGEN LOAD; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STOMATOTOXIC CHEMOTHERAPY; YEAST;

ANTI-INFECTIVE AGENTS; ANTIMICROBIAL CATIONIC PEPTIDES; ANTINEOPLASTIC AGENTS; BACTERIA, AEROBIC; BACTERIA, ANAEROBIC; BACTERIAL LOAD; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; GRAM-NEGATIVE BACTERIA; HUMANS; MALE; MIDDLE AGED; MOUTH MUCOSA; MOUTHWASHES; MYELOABLATIVE AGONISTS; PLACEBOS; SAFETY; STAPHYLOCOCCUS; STOMATITIS; STREPTOCOCCUS; TREATMENT OUTCOME; VIRIDANS STREPTOCOCCI; YEASTS;

EID: 84857783762     PISSN: 09042512     EISSN: 16000714     Source Type: Journal    
DOI: 10.1111/j.1600-0714.2011.01094.x     Document Type: Article

References (19)

1. Sixou JL, de Medeiros-Batista O, Bonnaure-Mallet M. Modifications of the microflora of the oral cavity arising during immunosuppressive chemotherapy. Eur J Cancer B Oral Oncol 1996; 32B: 306-10.
2. Donnelly JP. Bacterial complications of transplantation: diagnosis and treatment. J Antimicrob Chemother 1995; 36(Suppl B): 59-72.
3. Meurman JH, Pyrhonen S, Teerenhovi L, Lindqvist C. Oral sources of septicaemia in patients with malignancies. Oral Oncol 1997; 33: 389-97.
4. Quirynen M, Teughels W, De Soete M, van Steenberghe D. Topical antiseptics and antibiotics in the initial therapy of chronic adult periodontitis: microbiological aspects. Periodontol 2000 2002; 28: 72-90.
5. Giles FJ, Redman R, Yazji S, Bellm L. Iseganan HCl: a novel antimicrobial agent. Expert Opin Investig Drugs 2002; 11: 1161-70.
6. Giles FJ, Miller CB, Hurd DD, et al. A phase III, randomized, double-blind, placebo-controlled, multinational trial of iseganan for the prevention of oral mucositis in patients receiving stomatotoxic chemotherapy (PROMPT-CT trial). Leuk Lymphoma 2003; 44: 1165-72.
7. Giles FJ, Rodriguez R, Weisdorf D, et al. A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy. Leuk Res 2004; 28: 559-65.
8. Trotti A, Garden A, Warde P, et al. A multinational, randomized phase III trial of iseganan HCl oral solution for reducing the severity of oral mucositis in patients receiving radiotherapy for head-and-neck malignancy. Int J Radiat Oncol Biol Phys 2004; 58: 674-81.
9. Spijkervet FKL, van Saene HKF, Panders AK, Verney A. Colonization index of the oral cavity: a novel technique for monitoring colonization defence. Microbiol Ecol Health Dis 1989; 2: 145-51.
10. CLSI. Performance standards for antimicrobial susceptibility testing, 20th informational supplement (M100-S20), vol. 30. Clinical Laboratory Standards Institute, 2010; 1-160.
11. CLSI. Reference method for broth dilution antifungal susceptibility testing of yeasts; approved standard, 3rd edn. (M27-A3) vol. 28. Clinical Laboratory Standards Institute, 2008; 1-40.
12. Mosca DA, Hurst MA, So W, Viajar BS, Fujii CA, Falla TJ. IB-367, a protegrin peptide with in vitro and in vivo activities against the microflora associated with oral mucositis. Antimicrob Agents Chemother 2000; 44: 1803-8.
13. Kollef M, Pittet D, Sanchez Garcia M, et al. A randomized double-blind trial of iseganan in prevention of ventilator-associated pneumonia. Am J Respir Crit Care Med 2006; 173: 91-7.
14. Epstein JB, Truelove EL, Hanson-Huggins K, et al. Topical polyene antifungals in hematopoietic cell transplant patients: tolerability and efficacy. Support Care Cancer 2004; 12: 517-25.
15. Elad S, Wexler A, Garfunkel AA, Shapira MY, Bitan M, Or R. Oral candidiasis prevention in transplantation patients: a comparative study. Clin Transplant 2006; 20: 318-24.
16. Cohen J, Donnelly JP, Worsley AM, Catovsky D, Goldman JM, Galton DA. Septicaemia caused by viridans streptococci in neutropenic patients with leukaemia. Lancet 1983; 2: 1452-4.
17. Elting LS, Bodey GP, Keefe BH. Septicemia and shock syndrome due to viridans streptococci: a case-control study of predisposing factors. Clin Infect Dis 1992; 14: 1201-7.
18. Bochud P-Y, Cometta A, Francioli P. Virulent infections caused by alpha-haemolytic streptococci in cancer patients and their management. Current Opin Infect Dis 1997; 10: 422.
19. Steiner M, Villablanca J, Kersey J, et al. Viridans streptococcal shock in bone marrow transplantation patients. Am J Hematol 1993; 42: 354-8.