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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
Est. primary completion date
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


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)

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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

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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

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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

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* Note: There are 78 references in allClick 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
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