NCT00097734

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
540

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2004

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 14, 2006

Status Verified

February 1, 2006

First QC Date

November 29, 2004

Last Update Submit

February 12, 2006

Conditions

Diverticulitis, ColonicAcute Disease

Keywords

diverticulitisInvanzErtapenemacute attackssigmoid diverticulitisAcute attacks of sigmoid diverticulitis

Outcome Measures

Primary Outcomes (3)

  • Clinical therapeutic success (full regression)

  • Relapse rate

  • Operation rate

Secondary Outcomes (5)

  • Development of laboratory parameters

  • Duration of hospitalization

  • Duration of parenteral feeding

  • Incidence of surgical intervention and repeat surgery

  • Incidence and duration of intensive care

Interventions

ertapenemDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Hannover- Krankenhaus Siloah

Hanover, 30449, Germany

RECRUITING

Related Publications (78)

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    PMID: 2191360BACKGROUND

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    PMID: 1588224BACKGROUND

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    PMID: 10991855BACKGROUND

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    PMID: 6697835BACKGROUND

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    PMID: 1473412BACKGROUND

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    PMID: 3996147BACKGROUND

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    PMID: 507737BACKGROUND

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

    PMID: 735943BACKGROUND

  • 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.

    PMID: 1770284BACKGROUND

  • HORNER JL. A study of diverticulitis of the colon in office practice. Gastroenterology. 1952 Jun;21(2):223-9. No abstract available.

    PMID: 14937207BACKGROUND

  • 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.

    PMID: 3788398BACKGROUND

  • 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.

    PMID: 3492883BACKGROUND

  • 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.

    PMID: 1638578BACKGROUND

  • 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.

    PMID: 3250415BACKGROUND

  • 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.

    PMID: 6388723BACKGROUND

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    PMID: 2208880BACKGROUND

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

    PMID: 964566BACKGROUND

  • 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.

    PMID: 14463838BACKGROUND

  • 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.

    PMID: 2596257BACKGROUND

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    PMID: 6435365BACKGROUND

  • 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.

    PMID: 11353638BACKGROUND

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    PMID: 9860333BACKGROUND

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    PMID: 13999257BACKGROUND

  • 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.

    PMID: 3757702BACKGROUND

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    PMID: 13080959BACKGROUND

MeSH Terms

Conditions

Diverticulitis, ColonicAcute DiseaseDiverticulitis

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Diverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesDiverticulosis, ColonicColonic DiseasesIntestinal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ferdinand Koeckerling, Prof. Dr.

    Klinikum Hanover-Siloah hospital and Nordstadt hospital- Surgical Department

    STUDY CHAIR

Central Study Contacts

Ferdinand Koeckerling, Prof. Dr.

CONTACT

0049-511-927-2331ferdinand.koeckerling.siloah@klinikum-hannover.de

Omar Huegel, Dr.

CONTACT

0049-511-927-2331Dr.O.Huegel@arcor.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2004

First Posted

November 30, 2004

Study Start

July 1, 2004

Study Completion

June 1, 2007

Last Updated

February 14, 2006

Record last verified: 2006-02

Locations

DE(1)