Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis

Acute Disease Clinical Trial

Official title:

A Prospective, Multicenter, Open-Label, Randomized Clinical Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00097734
• Other study ID #: mc317
• Secondary ID: INVA-DIV-Study
• Status: Recruiting
• Phase: Phase 4
• First received: November 29, 2004
• Last updated: February 12, 2006
• Start date: July 2004
• Est. completion date: June 2007

Study information

• Verified date: February 2006
• Source: Klinikum Hanover-Siloah Hospital
• Contact: Ferdinand Koeckerling, Prof. Dr.
• Phone: 0049-511-927-2331
• Email: ferdinand.koeckerling.siloah[@]klinikum-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy (by assessing the clinical success of treatment) of intravenous antibiotic therapy with ertapenem in patients with acute attacks of sigmoid diverticulitis for 4 vs. 7 days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• At least three of the following signs or symptoms of an acute attack of sigmoid diverticulitis must be present: *Fever (body temperature > 38°C, sublingual), *Abdominal tenderness, *Leukocytosis (leukocytes > 10,000/µl) and left shift of the differential blood count (>1% band forms), *Elevated CRP (> 20 mg/l)

• Evidence of sigmoid diverticulitis by contrast enema

• CT evidence of wall thickening in the sigmoid intestine

• Decision in favor of conservative therapy on the basis of the case history and diagnosis

Exclusion Criteria:

• Contraindication for the use of the study medication or other beta-lactam antibiotics, e.g. patients with advanced renal impairment or patients requiring hemodialysis

• Antibiotic therapy in the two weeks prior to the start of the study

• Patients with an advanced incurable disease

• Patients with a hematologic/oncologic disease (leukemia, lymphoma)

• Patients on immunosuppressants

• Complications of sigmoid diverticulitis leading to an immediate indication for surgery

• Patients who have hypersensitivity to beta-lactam antibiotics

• Female patients who are pregnant or nursing or who could become pregnant during the study

• Participation in another clinical study or use of another study drug within the four weeks prior to enrollment in the study or use of another drug during the study

• Each patient can be enrolled only once in the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Acute Disease
• Diverticulitis
• Diverticulitis, Colonic

Intervention

Drug:
• ertapenem

Locations

Country	Name	City	State
Germany	Klinikum Hannover- Krankenhaus Siloah	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Hanover-Siloah Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (78)

Ambrosetti P, Robert J, Witzig JA, Mirescu D, de Gautard R, Borst F, Meyer P, Rohner A. Prognostic factors from computed tomography in acute left colonic diverticulitis. Br J Surg. 1992 Feb;79(2):117-9. — View Citation

Auguste L, Borrero E, Wise L. Surgical management of perforated colonic diverticulitis. Arch Surg. 1985 Apr;120(4):450-2. — View Citation

Bakker FC, Hoitsma HF, Den Otter G. The Hartmann procedure. Br J Surg. 1982 Oct;69(10):580-2. — View Citation

Balthazar EJ, Robinson DL, Megibow AJ, Ranson JH. Acute pancreatitis: value of CT in establishing prognosis. Radiology. 1990 Feb;174(2):331-6. — View Citation

Barry AL, Fuchs PC, Brown SD. In vitro activity of the ketolide ABT-773. Antimicrob Agents Chemother. 2001 Oct;45(10):2922-4. — View Citation

Bell GA, Panton ON. Hartmann resection for perforated sigmoid diverticulitis. A retrospective study of the Vancouver General Hospital experience. Dis Colon Rectum. 1984 Apr;27(4):253-6. — View Citation

Berry AR, Turner WH, Mortensen NJ, Kettlewell MG. Emergency surgery for complicated diverticular disease. A five-year experience. Dis Colon Rectum. 1989 Oct;32(10):849-54. — View Citation

BOLES RS Jr, JORDAN SM. The clinical significance of diverticulosis. Gastroenterology. 1958 Dec;35(6):579-82. — View Citation

Chappuis CW, Cohn I Jr. Acute colonic diverticulitis. Surg Clin North Am. 1988 Apr;68(2):301-13. Review. — View Citation

Cheskin LJ, Bohlman M, Schuster MM. Diverticular disease in the elderly. Gastroenterol Clin North Am. 1990 Jun;19(2):391-403. Review. — View Citation

Cheskin LJ, Lamport RD. Diverticular disease. Epidemiology and pharmacological treatment. Drugs Aging. 1995 Jan;6(1):55-63. Review. — View Citation

Cho KC, Morehouse HT, Alterman DD, Thornhill BA. Sigmoid diverticulitis: diagnostic role of CT--comparison with barium enema studies. Radiology. 1990 Jul;176(1):111-5. — View Citation

Chodak GW, Rangel DM, Passaro E Jr. Colonic diverticulitis in patients under age 40: need for earlier diagnosis. Am J Surg. 1981 Jun;141(6):699-702. — View Citation

Cunha BA. Ertapenem. A review of its microbiologic, pharmacokinetic and clinical aspects. Drugs Today (Barc). 2002 Mar;38(3):195-213. Review. — View Citation

Detry R, Jamez J, Kartheuser A, Zech F, Vanheuverzwijn R, Hoang P, Kestens PJ. Acute localized diverticulitis: optimum management requires accurate staging. Int J Colorectal Dis. 1992 Feb;7(1):38-42. — View Citation

Doringer E. Computerized tomography of colonic diverticulitis. Crit Rev Diagn Imaging. 1992;33(5):421-35. Review. — View Citation

Drusano GL, Warren JW, Saah AJ, Caplan ES, Tenney JH, Hansen S, Granados J, Standiford HC, Miller EH Jr. A prospective randomized controlled trial of cefoxitin versus clindamycin-aminoglycoside in mixed anaerobic-aerobic infections. Surg Gynecol Obstet. 1982 May;154(5):715-20. — View Citation

Duma RJ, Kellum JM. Colonic diverticulitis: microbiologic, diagnostic, and therapeutic considerations. Curr Clin Top Infect Dis. 1991;11:218-47. Review. — View Citation

Eisenstat TE, Rubin RJ, Salvati EP. Surgical management of diverticulitis. The role of the Hartmann procedure. Dis Colon Rectum. 1983 Jul;26(7):429-32. — View Citation

Elsakr R, Johnson DA, Younes Z, Oldfield EC 3rd. Antimicrobial treatment of intra-abdominal infections. Dig Dis. 1998 Jan-Feb;16(1):47-60. Review. — View Citation

Ertan A. Colonic diverticulitis. Recognizing and managing its presentations and complications. Postgrad Med. 1990 Sep 1;88(3):67-72; 77. Review. — View Citation

Eusebio EB, Eisenberg MM. Natural history of diverticular disease of the colon in young patients. Am J Surg. 1973 Mar;125(3):308-11. — View Citation

Ferzoco LB, Raptopoulos V, Silen W. Acute diverticulitis. N Engl J Med. 1998 May 21;338(21):1521-6. Review. — View Citation

Freischlag J, Bennion RS, Thompson JE Jr. Complications of diverticular disease of the colon in young people. Dis Colon Rectum. 1986 Oct;29(10):639-43. — View Citation

Goldstein EJ, Citron DM, Merriam CV, Warren Y, Tyrrell K. Comparative in vitro activities of GAR-936 against aerobic and anaerobic animal and human bite wound pathogens. Antimicrob Agents Chemother. 2000 Oct;44(10):2747-51. — View Citation

Gottesman L, Zevon SJ, Brabbee GW, Dailey T, Wichern WA Jr. The use of water-soluble contrast enemas in the diagnosis of acute lower left quadrant peritonitis. Dis Colon Rectum. 1984 Feb;27(2):84-8. — View Citation

Hachigian MP, Honickman S, Eisenstat TE, Rubin RJ, Salvati EP. Computed tomography in the initial management of acute left-sided diverticulitis. Dis Colon Rectum. 1992 Dec;35(12):1123-9. Erratum in: Dis Colon Rectum 1993 Feb;36(2):193. — View Citation

Hackford AW, Schoetz DJ Jr, Coller JA, Veidenheimer MC. Surgical management of complicated diverticulitis. The Lahey Clinic experience, 1967 to 1982. Dis Colon Rectum. 1985 May;28(5):317-21. — View Citation

Haglund U, Hellberg R, Johnsén C, Hultén L. Complicated diverticular disease of the sigmoid colon. An analysis of short and long term outcome in 392 patients. Ann Chir Gynaecol. 1979;68(2):41-6. — View Citation

Hiltunen KM, Kolehmainen H, Vuorinen T, Matikainen M. Early water-soluble contrast enema in the diagnosis of acute colonic diverticulitis. Int J Colorectal Dis. 1991 Nov;6(4):190-2. — View Citation

Hinchey EJ, Schaal PG, Richards GK. Treatment of perforated diverticular disease of the colon. Adv Surg. 1978;12:85-109. — View Citation

HORNER JL. A study of diverticulitis of the colon in office practice. Gastroenterology. 1952 Jun;21(2):223-9. — View Citation

Hulkko OA, Laitinen ST, Haukipuro KA, Ståhlberg MJ, Juvonen TS, Kairaluoma MI. The Hartmann procedure for the treatment of colorectal emergencies. Acta Chir Scand. 1986 Aug-Sep;152:531-5. — View Citation

Johnson CD, Baker ME, Rice RP, Silverman P, Thompson WM. Diagnosis of acute colonic diverticulitis: comparison of barium enema and CT. AJR Am J Roentgenol. 1987 Mar;148(3):541-6. — View Citation

Kellum JM, Sugerman HJ, Coppa GF, Way LR, Fine R, Herz B, Speck EL, Jackson D, Duma RJ. Randomized, prospective comparison of cefoxitin and gentamicin-clindamycin in the treatment of acute colonic diverticulitis. Clin Ther. 1992 May-Jun;14(3):376-84. — View Citation

Kourtesis GJ, Williams RA, Wilson SE. Acute diverticulitis: safety and value of contrast studies in predicting need for operation. Aust N Z J Surg. 1988 Oct;58(10):801-4. — View Citation

Krukowski ZH, Matheson NA. Emergency surgery for diverticular disease complicated by generalized and faecal peritonitis: a review. Br J Surg. 1984 Dec;71(12):921-7. Review. — View Citation

Laitinen R, Tähtinen J, Lantto T, Vorne M. Tc-99m labeled leukocytes in imaging of patients with suspected acute abdominal inflammation. Clin Nucl Med. 1990 Sep;15(9):597-602. — View Citation

Larson DM, Masters SS, Spiro HM. Medical and surgical therapy in diverticular disease: a comparative study. Gastroenterology. 1976 Nov;71(5):734-7. — View Citation

LEIGH JE, JUDD ES, WAUGH JM. Diverticulitis of the colon. Recurrence after apparently adequate segmental resection. Am J Surg. 1962 Jan;103:51-4. — View Citation

Lindahl J, Ristkari SK, Vorne M, Mokka RE. 99m-technetium-HmPAO-labelled leucocytes in the diagnosis of acute colonic diverticulitis. Acta Chir Scand. 1989 Sep;155(9):479-82. — View Citation

Ling L, Aberg T. Hartmann procedure. Acta Chir Scand. 1984;150(5):413-7. — View Citation

Livermore DM, Carter MW, Bagel S, Wiedemann B, Baquero F, Loza E, Endtz HP, van Den Braak N, Fernandes CJ, Fernandes L, Frimodt-Moller N, Rasmussen LS, Giamarellou H, Giamarellos-Bourboulis E, Jarlier V, Nguyen J, Nord CE, Struelens MJ, Nonhoff C, Turnidge J, Bell J, Zbinden R, Pfister S, Mixson L, Shungu DL. In vitro activities of ertapenem (MK-0826) against recent clinical bacteria collected in Europe and Australia. Antimicrob Agents Chemother. 2001 Jun;45(6):1860-7. — View Citation

Mäkelä J, Vuolio S, Kiviniemi H, Laitinen S. Natural history of diverticular disease: when to operate? Dis Colon Rectum. 1998 Dec;41(12):1523-8. — View Citation

Mazuski JE, Sawyer RG, Nathens AB, DiPiro JT, Schein M, Kudsk KA, Yowler C; Therapeutic Agents Committee of the Surgical Infections Society. The Surgical Infection Society guidelines on antimicrobial therapy for intra-abdominal infections: evidence for the recommendations. Surg Infect (Larchmt). 2002 Fall;3(3):175-233. — View Citation

McConnell EJ, Tessier DJ, Wolff BG. Population-based incidence of complicated diverticular disease of the sigmoid colon based on gender and age. Dis Colon Rectum. 2003 Aug;46(8):1110-4. — View Citation

McGOWAN FJ, WOLFF WI. Diverticulitis of the sigmoid colon. Gastroenterology. 1952 May;21(1):119-32. — View Citation

Morris J, Stellato TA, Lieberman J, Haaga JR. The utility of computed tomography in colonic diverticulitis. Ann Surg. 1986 Aug;204(2):128-32. — View Citation

Murray JJ, Schoetz DJ Jr, Coller JA, Roberts PL, Veidenheimer MC. Intraoperative colonic lavage and primary anastomosis in nonelective colon resection. Dis Colon Rectum. 1991 Jul;34(7):527-31. — View Citation

Nagorney DM, Adson MA, Pemberton JH. Sigmoid diverticulitis with perforation and generalized peritonitis. Dis Colon Rectum. 1985 Feb;28(2):71-5. — View Citation

Nichols RL. Management of intra-abdominal sepsis. Am J Med. 1986 Jun 30;80(6B):204-9. Review. — View Citation

Odenholt I, Löwdin E, Cars O. In vitro pharmacodynamic studies of L-749,345 in comparison with imipenem and ceftriaxone against gram-positive and gram-negative bacteria. Antimicrob Agents Chemother. 1998 Sep;42(9):2365-70. — View Citation

Painter NS. Diverticular disease of the colon. The first of the Western diseases shown to be due to a deficiency of dietary fibre. S Afr Med J. 1982 Jun 26;61(26):1016-20. — View Citation

Papi C, Ciaco A, Koch M, Capurso L. Efficacy of rifaximin in the treatment of symptomatic diverticular disease of the colon. A multicentre double-blind placebo-controlled trial. Aliment Pharmacol Ther. 1995 Feb;9(1):33-9. — View Citation

Parks TG, Connell AM. The outcome in 455 patients admitted for treatment of diverticular disease of the colon. Br J Surg. 1970 Oct;57(10):775-8. — View Citation

Parks TG. Natural history of diverticular disease of the colon. A review of 521 cases. Br Med J. 1969 Dec 13;4(5684):639-42. — View Citation

Perkins JD, Shield CF 3rd, Chang FC, Farha GJ. Acute diverticulitis. Comparison of treatment in immunocompromised and nonimmunocompromised patients. Am J Surg. 1984 Dec;148(6):745-8. — View Citation

Pontari MA, McMillen MA, Garvey RH, Ballantyne GH. Diagnosis and treatment of enterovesical fistulae. Am Surg. 1992 Apr;58(4):258-63. — View Citation

Porta E, Germano A, Ferrieri A, Koch M. The natural history of diverticular disease of the colon: a role for antibiotics in preventing complications? A retrospective study. Riv Eur Sci Med Farmacol. 1994 Jan-Apr;16(1-2):33-9. — View Citation

Rege RV, Nahrwold DL. Diverticular disease. Curr Probl Surg. 1989 Mar;26(3):133-89. Review. — View Citation

Roberts P, Abel M, Rosen L, Cirocco W, Fleshman J, Leff E, Levien D, Pritchard T, Wexner S, Hicks T, et al. Practice parameters for sigmoid diverticulitis. The Standards Task Force American Society of Colon and Rectal Surgeons. Dis Colon Rectum. 1995 Feb;38(2):125-32. — View Citation

Sarin S, Boulos PB. Evaluation of current surgical management of acute inflammatory diverticular disease. Ann R Coll Surg Engl. 1991 Sep;73(5):278-82. — View Citation

Schechter S, Mulvey J, Eisenstat TE. Management of uncomplicated acute diverticulitis: results of a survey. Dis Colon Rectum. 1999 Apr;42(4):470-5; discussion 475-6. — View Citation

Schwerk WB, Schwarz S, Rothmund M. Sonography in acute colonic diverticulitis. A prospective study. Dis Colon Rectum. 1992 Nov;35(11):1077-84. — View Citation

Shah PM, Isaacs RD. Ertapenem, the first of a new group of carbapenems. J Antimicrob Chemother. 2003 Oct;52(4):538-42. Epub 2003 Sep 1. Review. — View Citation

Smith TR, Cho KC, Morehouse HT, Kratka PS. Comparison of computed tomography and contrast enema evaluation of diverticulitis. Dis Colon Rectum. 1990 Jan;33(1):1-6. — View Citation

Solomkin JS, Yellin AE, Rotstein OD, Christou NV, Dellinger EP, Tellado JM, Malafaia O, Fernandez A, Choe KA, Carides A, Satishchandran V, Teppler H; Protocol 017 Study Group. Ertapenem versus piperacillin/tazobactam in the treatment of complicated intraabdominal infections: results of a double-blind, randomized comparative phase III trial. Ann Surg. 2003 Feb;237(2):235-45. — View Citation

Starnes HF Jr, Lazarus JM, Vineyard G. Surgery for diverticulitis in renal failure. Dis Colon Rectum. 1985 Nov;28(11):827-31. — View Citation

Taylor KJ, Wasson JF, De Graaff C, Rosenfield AT, Andriole VT. Accuracy of grey-scale ultrasound diagnosis of abdominal and pelvic abscesses in 220 patients. Lancet. 1978 Jan 14;1(8055):83-4. — View Citation

Tellado J, Woods GL, Gesser R, McCarroll K, Teppler H. Ertapenem versus piperacillin-tazobactam for treatment of mixed anaerobic complicated intra-abdominal, complicated skin and skin structure, and acute pelvic infections. Surg Infect (Larchmt). 2002 Winter;3(4):303-14. — View Citation

Thompson WG, Patel DG. Clinical picture of diverticular disease of the colon. Clin Gastroenterol. 1986 Oct;15(4):903-16. Review. — View Citation

Tyau ES, Prystowsky JB, Joehl RJ, Nahrwold DL. Acute diverticulitis. A complicated problem in the immunocompromised patient. Arch Surg. 1991 Jul;126(7):855-8; discussion 858-9. — View Citation

Ulin AW, Pearce AE, Weinstein SF. Diverticular disease of the colon: surgical perspectives in the past decade. Dis Colon Rectum. 1981 May-Jun;24(4):276-81. — View Citation

Verbanck J, Lambrecht S, Rutgeerts L, Ghillebert G, Buyse T, Naesens M, Tytgat H. Can sonography diagnose acute colonic diverticulitis in patients with acute intestinal inflammation? A prospective study. J Clin Ultrasound. 1989 Nov-Dec;17(9):661-6. — View Citation

WAUGH JM, WALT AJ. Current trends in the surgical treatment of diverticulitis of the sigmoid colon. Surg Clin North Am. 1962 Oct;42:1267-76. — View Citation

WELCH CE, ALLEN AW, DONALDSON GA. An appraisal of resection of the colon for diverticulitis of the sigmoid. Ann Surg. 1953 Sep;138(3):332-43. — View Citation

Wexner SD, Dailey TH. The initial management of left lower quadrant peritonitis. Dis Colon Rectum. 1986 Oct;29(10):635-8. — View Citation

Woods RJ, Lavery IC, Fazio VW, Jagelman DG, Weakley FL. Internal fistulas in diverticular disease. Dis Colon Rectum. 1988 Aug;31(8):591-6. — View Citation

* Note: There are 78 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical therapeutic success (full regression)
Primary	Relapse rate
Primary	Operation rate
Secondary	Development of laboratory parameters
Secondary	Duration of hospitalization
Secondary	Duration of parenteral feeding
Secondary	Incidence of surgical intervention and repeat surgery
Secondary	Incidence and duration of intensive care