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Diverticulitis, ColonicPhase 4NCT00097734

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

A Phase 4 study testing ertapenem in people with Diverticulitis, Colonic and Acute Disease, run by Klinikum Hanover-Siloah Hospital at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diverticulitis, Colonic, Acute Disease
What is being tested?
ertapenem
How many people
540 participants
Where
1 siteGermany
Study dates
Jul 2004to Jun 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Ferdinand Koeckerling, Prof. Dr. contact

0049-511-927-2331

ferdinand.koeckerling.siloah@klinikum-hannover.de

Omar Huegel, Dr. contact

0049-511-927-2331

Dr.O.Huegel@arcor.de

Germany1 site, 1 recruiting

  • Klinikum Hannover- Krankenhaus Siloah

    Hanover, 30449

    Omar Huegel, Dr., 0049-511-927-2331

    Ferdinand Koeckerling, Prof. Dr.

    Recruiting

Other trials in Germany

About this study

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

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.

Being tested
ertapenem
Keywords
diverticulitis, Invanz, Ertapenem, acute attacks, sigmoid diverticulitis, Acute attacks of sigmoid diverticulitis
Medical subject headings
Diverticulitis, Colonic, Acute Disease, Diverticulitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ertapenemDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical therapeutic success (full regression)

  2. Relapse rate

  3. Operation rate

Secondary outcomes (5)

  1. Development of laboratory parameters

  2. Duration of hospitalization

  3. Duration of parenteral feeding

  4. Incidence of surgical intervention and repeat surgery

  5. Incidence and duration of intensive care

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2004 (estimated)
  2. Study startJul 2004
  3. Study completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Early clinical test
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
540 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00097734
Sponsor's protocol ID
mc317
Other IDs
INVA-DIV-Study
Status last verified
Feb 2006
First submitted
29 Nov 2004
Last updated
14 Feb 2006
Results posted
No

Publications

  • 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.

    PubMed 1555056

  • 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.

    PubMed 3985790

  • Bakker FC, Hoitsma HF, Den Otter G. The Hartmann procedure. Br J Surg. 1982 Oct;69(10):580-2. doi: 10.1002/bjs.1800691007.

    PubMed 7127036

  • Balthazar EJ, Robinson DL, Megibow AJ, Ranson JH. Acute pancreatitis: value of CT in establishing prognosis. Radiology. 1990 Feb;174(2):331-6. doi: 10.1148/radiology.174.2.2296641.

    PubMed 2296641

  • 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.

    PubMed 6714033

  • 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.

    PubMed 2791771

  • BOLES RS Jr, JORDAN SM. The clinical significance of diverticulosis. Gastroenterology. 1958 Dec;35(6):579-82. No abstract available.

    PubMed 13609810

  • Chappuis CW, Cohn I Jr. Acute colonic diverticulitis. Surg Clin North Am. 1988 Apr;68(2):301-13. doi: 10.1016/s0039-6109(16)44479-8.

    PubMed 3279548

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

    PubMed 2194951

  • Cheskin LJ, Lamport RD. Diverticular disease. Epidemiology and pharmacological treatment. Drugs Aging. 1995 Jan;6(1):55-63. doi: 10.2165/00002512-199506010-00005.

    PubMed 7696779

  • 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. doi: 10.1148/radiology.176.1.2191360.

    PubMed 2191360

  • 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. doi: 10.1016/0002-9610(81)90081-7. No abstract available.

    PubMed 7246860

  • Cunha BA. Ertapenem. A review of its microbiologic, pharmacokinetic and clinical aspects. Drugs Today (Barc). 2002 Mar;38(3):195-213. doi: 10.1358/dot.2002.38.3.820127.

    PubMed 12532175

  • 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. doi: 10.1007/BF01647660.

    PubMed 1588224

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

    PubMed 1418606

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ertapenem in people with Diverticulitis, Colonic and Acute Disease, run by Klinikum Hanover-Siloah Hospital at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ferdinand Koeckerling, Prof. Dr. (0049-511-927-2331, ferdinand.koeckerling.siloah@klinikum-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical therapeutic success (full regression). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00097734, which also lists 78 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2006.

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