Clinical efficacy, tolerability, and cost savings associated with the use of open-label metronidazole plus ceftriaxone once daily compared with ticarcillin/clavulanate every 6 hours as empiric treatment for diabetic lower-extremity infections in older males

American Journal Geriatric Pharmacotherapy

Volumn 2, Issue 3, 2004, Pages 181-189

  Clay, Patrick G ^a,b   Graham, Maqual R ^a,c   Lindsey, Cameron C ^a,c   Lamp, Kenneth C ^d   Freeman, Collin ^e   Glaros, Alan ^a  

^a UNIVERSITY OF MISSOURI KANSAS CITY   (United States)

^b Kansas City Free Health Clinic   (United States)

^c VETERANS AFFAIRS MEDICAL CENTER   (United States)

^d Cubist Pharmaceuticals Inc   (United States)

^e VHA Inc   (United States)

Author keywords

Ceftriaxone; Diabetes; Lower extremity infection; Metronidazole; Ticarcillin clavulanate

Indexed keywords

ANTIBIOTIC AGENT; CEFTRIAXONE; METRONIDAZOLE; TIMENTIN;

ADULT; AGED; ARTICLE; BODY TEMPERATURE; CLINICAL TRIAL; COMORBIDITY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST CONTROL; CREATININE CLEARANCE; DIABETIC FOOT; DRUG COST; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG TOLERABILITY; DRUG USE; DRUG WITHDRAWAL; GLUCOSE BLOOD LEVEL; HOSPITAL ADMISSION; HOSPITAL COST; HOSPITAL PATIENT; HUMAN; LEUKOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; OPEN STUDY; PREDICTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SOFT TISSUE INFECTION; TREATMENT FAILURE; TREATMENT OUTCOME; WOUND HEALING;

AGED; ANTI-BACTERIAL AGENTS; BACTERIAL INFECTIONS; CEFTRIAXONE; CLAVULANIC ACIDS; COST SAVINGS; DIABETIC FOOT; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; DRUG COSTS; DRUG THERAPY, COMBINATION; HOSPITAL COSTS; HOSPITALIZATION; HUMANS; MALE; METRONIDAZOLE; PROSPECTIVE STUDIES; TICARCILLIN; TREATMENT OUTCOME;

EID: 10244260343     PISSN: 15435946     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.amjopharm.2004.09.006     Document Type: Article

References (42)

1. Gonzalez M.H. Bochar S. Novomy J. et al. Upper extremity infections in patients with diabetes mellitus J Hand Surg [Am] 24 1999 682-686
2. Eneroth M. Larsson J. Apelqvist J. Deep foot infections in patients with diabetes and foot ulcer: An entity with different characteristics, treatments, and prognosis J Diabetes Complications 13 1999 254-263
3. Grayson M.L. Diabetic foot infections. Antimicrobial therapy Infect Dis Clin North Am 9 1995 143-161
4. Kemmerly S.A. Dermatologie manifestations of infections in diabetics Infect Dis Clin North Am 8 1994 523-532
5. Olson D. Guidos R.J. Bad bugs, no drugs: As antibiotic development stagnates... a public health crisis brews 2004 Infectious Diseases Society of America Policy and Advocacy Statement Available at: http://www.idsociety.org/badbugsnodrugs. Accessed April 1, 2004
6. Sullivan S.D. Investing in health: Research and development In: Sullivan S.D. Best T.M., eds. Value of Medicines: Past Successes and Positive Prognoses Pharmaceutical Research and Development 2004 University of Wisconsin Medical School Madison, Wise 16-19
7. Pankcy G.A. Diagnosis and treatment of skin and soft tissue infections: Clinical experience with ticarcillin disodium-clavulanate potassium Pharmacotherapy 11 1999 90s-98S
8. File T.M. Jr. Tan J.S. Ticarcillin-clavulanate therapy for bacterial skin and soft tissue infections Rev Infect Dis. 13 Suppl 9 1991 S733-S736
9. Akova M. Ozcebe O. Gullu I. et al. Efficacy of sulbactam-ampicillin for the treatment of severe diabetic foot infections J Chemother 8 1996 284-289
10. Grayson M.L. Gibbons G.W. Habershaw G.M. et al. Use of ampicillin/sulbactam versus imipenem/cilastatin in the treatment of limb-threatening foot infections in diabetic patients [published correction appears in Clin Infect Dis. 1994,19:820] Clin Infect Dis 18 1994 683-693
11. Seabrook G.R. Edmiston C.E. Schmitt D.D. et al. Comparison of serum and tissue antibiotic levels in diabetes-related foot infections Surgery 110 1991 671-676
12. Donskey C.J. Hanrahan J.A. Hutton R.A. Rice L.B. Effect of parenteral antibiotic administration on persistence of vancomycin-resistant Enterococcus faecium in the mouse gastrointestinal tract J Infect Dis 180 1999 384-390
13. Pathare A. Sathe S.R. Talvalkar G.V. Raheja B.S. Bacterial infections in diabetic foot J Diab Assoc India 37 1997 8-12
14. Washington J.A. Jones R.N. Allen S.D. et al. In vitro comparison of GR69153, a novel catechol-substituted cephalosporin, with ceftazidime and ceftriaxone against 5,203 recent clinical isolates Antimicrob Agents Chemother 35 1991 1508-1511
15. Bradsher R.W. Jr. Snow R.M. Ceftriaxone treatment of skin and soft tissue infections in a once daily regimen Am J Med 77 1984 63-67
16. Blumer J. Pharmacokinetics of ceftriaxone Hosp Pract (Off Ed) 26 Suppl 5 1991 7-13
17. Aldridge K.E. Gelfand M. Reller L.B. et al. A five-year multicenter study of the susceptibility of the Bacteroides fragilis group isolates to cephalosporins, cephamins, penicillins, clindamycin, and metronidazole in the United States Diagn Microbial Infect Dis 18 1994 235-241
18. Freeman C.D. Nightingale C.H. Nicolau D.P. et al. Bactericidal activity of low-dose ceftizoxime plus metronidazole compared wth cefoxitin and ampicillin-sulbactam Pharmacotherapy 14 1994 185-190
19. Freeman C.D. Nightingale C.H. Nicolau D.P. et al. Serum bactericidal activity of ceftriaxone plus metronidazole against common intra-abdominal pathogens Am J Hosp Pharm 51 1994 1782-1787
20. Martin C. Sastre B. Mallet M.N. et al. Pharmacokinetics and tissue penetration of a single 1,000-milligram, intravenous dose of metronidazole for antibiotic prophylaxis of colorectal surgery Antimicrob Agents Chemother 35 1991 2602-2605
21. Luke M. Iversen J. Sondergaard J. et al. Ceftriaxone/metronidazole is more effective than ampicillin/netilmicin/metronidazole in the treatment of bacterial peritonitis Eur J Surg 157 1991 397-401
22. Lacy M.K. Paul R. Gordan-Ross G.R. et al. Clinical efficacy of ceftriaxone plus metronidazole in hospitalized patients with documented infections Presented at the 40th Annual Meeting of the Infectious Diseases Society of America October 24-27, 2002 Chicago, Ill. Abstract 203. Available at: http:www.journals.uchicago.edu/CID/2002Abstracts.html. Accessed May 19, 2003
23. Wagner F.W. Jr. The dysvascular foot: A system for diagnosis and treatment Foot Ankle 2 1981 64-122
24. Cockcroft D.W. Gault M.H. Prediction of creatininc clearance from serum creatinine Nephron 16 1976 31-41
25. Timentin [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2001
26. Rocephin [package insert]. Nutley, NJ: Roche Laboratories; 2000
27. Metronidazole intravenous infusion 500mg/100ml, (Viaflex® Minibag) [data sheet]. Available at: http://medsafe.govt.nz/Profs/Datasheet/m/Metronidazolebaxterinf.htm. Accessed April 6, 2004
28. Siami F.S. LaFleur B.J. Siami G.A. Clinafloxacin versus piperacillin/tazobactam in the treatment of severe skin and soft-tissue infections in adults at a Veterans Affairs medical center Clin Ther 24 2002 59-72
29. Mayfield J.A. Reiber G.E. Sanders L.J. et al. Preventive foot care in diabetes Diabetes Care 27 Suppl 1 2004 S63-S64
30. Siebert W.T. Kopp P.E. Ticarcillin plus clavulanic acid versus moxalactam therapy of osteomyclitis, septic arthritis, and skin and soft tissue infections Am J Med 79 1985 141-145
31. Graham D.R. Talan D.A. Nichols R.L. et al. Once-daily, high-dose levofloxacin versus ticarcillin-clavulanate alone or followed by amoxicillin-clavulanate for complicated skin and skin-structure infections: A randomized, open-label trial Clin Infect Dis 35 2002 381-389
32. Nix D.E. Cumbo T.J. Kuritzky P. et al. Oral ciprofloxacin in the treatment of serious soft tissue and bone infections. Efficacy, safety, and pharmacokinetics Am J Med 82 1987 146-153
33. Frykberg R.G. Armstrong D.G. Giurini J. et al. for the American College of Foot and Ankle Surgeons Diabetic foot disorders: A clinical practice guideline J Foot Ankle Surg 39 Suppl 5 2000 S1-S60
34. Yellin A.E. Hassett J.M. Fernandez A. et al. for the 004 Intra-abdominal Infection Study Group Ertapenem monothcrapy versus combination therapy with ceftriaxone plus metronidazole for treatment of complicated intra-abdominal infections in adults Int J Antimicrob Agents 20 2002 165-173
35. Starakis I. Karravias D. Asimakopoulos C. et al. Results of a prospective, randomized, double blind comparison of the efficacy and the safety of sequential ciprofloxacin (intravenous/oral)+metronidazole (intravenous/oral) with ceftriaxone (intravenous)+metronidazole (intravenous/oral) for the treatment of intra-abdominal infections Int J Antimicrob Agents 21 2003 49-57
36. Woodfield J.C. Van Rij A.M. Pettigrew R.A. et al. A comparison of the prophylactic efficacy of ceftriaxone and cefotaxime in abdominal surgery Am J Surg 185 2003 45-49
37. Holzer S.E. Camerota A. Martens L. et al. Costs and duration of care for lower extremity ulcers in patients with diabetes [published correction appears in Clin Ther. 1998;20:373] Clin Ther 20 1998 169-181
38. McKinnon P.S. Neuhauser M.M. Efficacy and cost of ampicillin-sulbactam and ticarcillin-clavulanate in the treatment of hospitalized patients with bacterial infections Pharmacotherapy 19 1999 724-733
39. Rivers T.E. Webster A.A. Stability of ceftizoxime sodium, ceftriaxone sodium, and ceftazidime with metronidazole in ready-to-use metronidazole bags Am J Health Syst Pharm 52 1995 2568-2570
40. Bailey L.C. Orosz S.T. Jr. Stability of ceftriaxone sodium and metronidazole hydrochloride Am J Health Syst Pharm 54 1997 424-427
41. Holloway W.J. Treatment of infections in hospitalized patients with ticarcillin plus clavulanic acid. A comparative study Am J Med 79 1985 168-171
42. Ruol A. Bertiato G. Boscarin S. et al. Short-term prophylaxis with ceftriaxone plus metronidazole in esophageal cancer surgery J Chemother 12 Suppl 3 2000 23-28