Undersøgelse for at evaluere varigheden af behandling med Ertapenem ved akutte angreb af sigmoid diverticulitis
12. februar 2006 opdateret af: Klinikum Hanover-Siloah Hospital
En prospektiv, multicenter, open-label, randomiseret klinisk undersøgelse for at evaluere varigheden af behandling med ertapenem ved akutte anfald af sigmoid diverticulitis
Formålet med denne undersøgelse er at sammenligne effektiviteten (ved at vurdere den kliniske succes af behandlingen) af intravenøs antibiotikabehandling med ertapenem hos patienter med akutte anfald af sigmoid diverticulitis i 4 vs. 7 dage.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding
540
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Hannover, Tyskland, 30449
- Rekruttering
- Klinikum Hannover- Krankenhaus Siloah
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Kontakt:
- Omar Huegel, Dr.
- Telefonnummer: 0049-511-927-2331
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Ledende efterforsker:
- Ferdinand Koeckerling, Prof. Dr.
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Underforsker:
- Omar Huegel, Dr.
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Underforsker:
- Pascal Geers, Dr.
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
14 år til 71 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Mindst tre af følgende tegn eller symptomer på et akut anfald af sigmoid diverticulitis skal være til stede: *Feber (kropstemperatur > 38°C, sublingualt), *Maveømhed, *Leukocytose (leukocytter > 10.000/µl) og venstreforskydning af det differentielle blodtal (>1 % båndformer), *Forhøjet CRP (> 20 mg/l)
- Bevis på sigmoid diverticulitis ved kontrastlavement
- CT-bevis på vægfortykkelse i sigmoideumtarmen
- Beslutning til fordel for konservativ terapi på baggrund af sygdomshistorie og diagnose
Ekskluderingskriterier:
- Kontraindikation for brug af undersøgelsesmedicinen eller andre beta-lactam antibiotika, f.eks. patienter med fremskreden nyreinsufficiens eller patienter, der har behov for hæmodialyse
- Antibiotisk behandling i de to uger før undersøgelsens start
- Patienter med en fremskreden uhelbredelig sygdom
- Patienter med en hæmatologisk/onkologisk sygdom (leukæmi, lymfom)
- Patienter på immunsuppressiva
- Komplikationer af sigmoid diverticulitis, der fører til en øjeblikkelig indikation for operation
- Patienter, der har overfølsomhed over for beta-lactam antibiotika
- Kvindelige patienter, der er gravide eller ammer, eller som kunne blive gravide under undersøgelsen
- Deltagelse i en anden klinisk undersøgelse eller brug af et andet undersøgelseslægemiddel inden for de fire uger forud for tilmelding til undersøgelsen eller brug af et andet lægemiddel under undersøgelsen
- Hver patient kan kun tilmeldes én gang i undersøgelsen
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Uddannelse/Rådgivning/Træning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Tilbagefaldsfrekvens
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Klinisk terapeutisk succes (fuld regression)
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Driftshastighed
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Sekundære resultatmål
Resultatmål |
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Udvikling af laboratorieparametre
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Indlæggelsens varighed
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Varighed af parenteral fodring
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Forekomst af kirurgisk indgreb og gentagen operation
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Incidens og varighed af intensiv pleje
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Ferdinand Koeckerling, Prof. Dr., Klinikum Hanover-Siloah hospital and Nordstadt hospital- Surgical Department
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- 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. doi: 10.1002/bjs.1800790208.
- Auguste L, Borrero E, Wise L. Surgical management of perforated colonic diverticulitis. Arch Surg. 1985 Apr;120(4):450-2. doi: 10.1001/archsurg.1985.01390280044010.
- Bakker FC, Hoitsma HF, Den Otter G. The Hartmann procedure. Br J Surg. 1982 Oct;69(10):580-2. doi: 10.1002/bjs.1800691007.
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- 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.
- 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. doi: 10.1007/BF02554554.
- BOLES RS Jr, JORDAN SM. The clinical significance of diverticulosis. Gastroenterology. 1958 Dec;35(6):579-82. No abstract available.
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- Barry AL, Fuchs PC, Brown SD. In vitro activity of the ketolide ABT-773. Antimicrob Agents Chemother. 2001 Oct;45(10):2922-4. doi: 10.1128/AAC.45.10.2922-2924.2001.
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- 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. doi: 10.1007/BF02251962. Erratum In: Dis Colon Rectum 1993 Feb;36(2):193.
- 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. doi: 10.1007/BF02560431.
- Haglund U, Hellberg R, Johnsen C, Hulten 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. No abstract available.
- 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. doi: 10.1007/BF00341388.
- HORNER JL. A study of diverticulitis of the colon in office practice. Gastroenterology. 1952 Jun;21(2):223-9. No abstract available.
- Hulkko OA, Laitinen ST, Haukipuro KA, Stahlberg MJ, Juvonen TS, Kairaluoma MI. The Hartmann procedure for the treatment of colorectal emergencies. Acta Chir Scand. 1986 Aug-Sep;152:531-5.
- 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. doi: 10.2214/ajr.148.3.541.
- 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.
- 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. doi: 10.1111/j.1445-2197.1988.tb00983.x.
- 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. doi: 10.1002/bjs.1800711202.
- Laitinen R, Tahtinen 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. doi: 10.1097/00003072-199009000-00001.
- Larson DM, Masters SS, Spiro HM. Medical and surgical therapy in diverticular disease: a comparative study. Gastroenterology. 1976 Nov;71(5):734-7.
- LEIGH JE, JUDD ES, WAUGH JM. Diverticulitis of the colon. Recurrence after apparently adequate segmental resection. Am J Surg. 1962 Jan;103:51-4. doi: 10.1016/0002-9610(62)90012-0. No abstract available.
- 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.
- Ling L, Aberg T. Hartmann procedure. Acta Chir Scand. 1984;150(5):413-7.
- 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. doi: 10.1128/AAC.45.6.1860-1867.2001.
- Makela J, Vuolio S, Kiviniemi H, Laitinen S. Natural history of diverticular disease: when to operate? Dis Colon Rectum. 1998 Dec;41(12):1523-8. doi: 10.1007/BF02237300.
- 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. doi: 10.1089/109629602761624180.
- 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. doi: 10.1007/s10350-004-7288-4.
- McGOWAN FJ, WOLFF WI. Diverticulitis of the sigmoid colon. Gastroenterology. 1952 May;21(1):119-32. No abstract available.
- Morris J, Stellato TA, Lieberman J, Haaga JR. The utility of computed tomography in colonic diverticulitis. Ann Surg. 1986 Aug;204(2):128-32. doi: 10.1097/00000658-198608000-00005.
- 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. doi: 10.1007/BF02049889.
- Nagorney DM, Adson MA, Pemberton JH. Sigmoid diverticulitis with perforation and generalized peritonitis. Dis Colon Rectum. 1985 Feb;28(2):71-5. doi: 10.1007/BF02552645.
- Nichols RL. Management of intra-abdominal sepsis. Am J Med. 1986 Jun 30;80(6B):204-9. doi: 10.1016/0002-9343(86)90502-4.
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- 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.
- 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. doi: 10.1111/j.1365-2036.1995.tb00348.x.
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- 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. doi: 10.1016/0002-9610(84)90429-x.
- Pontari MA, McMillen MA, Garvey RH, Ballantyne GH. Diagnosis and treatment of enterovesical fistulae. Am Surg. 1992 Apr;58(4):258-63.
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- Wexner SD, Dailey TH. The initial management of left lower quadrant peritonitis. Dis Colon Rectum. 1986 Oct;29(10):635-8. doi: 10.1007/BF02560324.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2004
Studieafslutning
1. juni 2007
Datoer for studieregistrering
Først indsendt
29. november 2004
Først indsendt, der opfyldte QC-kriterier
29. november 2004
Først opslået (Skøn)
30. november 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. februar 2006
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. februar 2006
Sidst verificeret
1. februar 2006
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- mc317
- INVA-DIV-Study
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .