Status:
COMPLETED
Ciprofloxacin for the Prevention of Postoperative Endoscopic Recurrence in Crohn's Disease
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Crohn's and Colitis Foundation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Despite extensive medical treatment, surgical resection is required in approximately 70% of the patients at some time. However, recurrence of the disease after operation occurs in the majority of pati...
Detailed Description
Despite extensive medical treatment, surgical resection is required in approximately 70% of the patients at some time. However, recurrence of the disease after operation occurs in the majority of pati...
Eligibility Criteria
Inclusion
- Signed informed consent.
- Man or woman between 18 and 70 years of age.
- Diagnosis of Crohn's disease confirmed during index surgery.
- Detailed assessment of disease localization by colonoscopy, small bowel radiography, and/or other appropriate methods (e.g., MRI, CT) within 6 months prior inclusion into the study.
- Resection for ileal or ileo-colonic Crohn's disease with ileo-colonic anastomosis (i.e., without grossly visible disease at the resection margins); neoterminal ileum should be assessable by endoscopy.
- Ability to start oral nutrition and medication intake within 14 days after index surgery.
- Negative pregnancy test at screening visit in females of childbearing potential.
- Use of appropriate contraceptive methods for females of childbearing potential and males with procreative capacity during treatment.
Exclusion
- Short bowel syndrome.
- Previous long term therapy with ciprofloxacin (\> 6 weeks prior before surgery)
- Patients in whom any visible lesions at the anastomosis were left after index surgery.
- Serious secondary illnesses of an acute or chronic nature, which in the opinion of the Investigator renders the patient unsuitable for inclusion into the study.
- Dementia
- Uncontrolled Diabetes Type I type II
- Known drug abuse
- Known parasitic disease of the digestive system
- Active replicating Hepatitis B or Hepatitis C
- HIV-infection
- Seizure disorder
- Serum creatinine levels exceeding 1.5 mg/dL or 130 μmol/L.
- Presence of an ileal or colonic stoma.
- Known previous or concurrent malignancy (other than that considered surgically cured, with no evidence for recurrence for 5 years).
- Application of non-steroidal anti-inflammatory drugs as long term treatment.
- Known intolerance/hypersensitivity to ciprofloxacin or other quinolones or drugs of similar chemical structure or pharmacological profile.
- Chronic use of CYP1A2 substrates (aminophylline, fluvoxamine, mexiletine, mirtazapine, ropinirole, tizanidine, trifluoperazine)
- Well-founded doubt about the patient's cooperation.
- Existing pregnancy, lactation, or intended pregnancy or impregnation within the next 3 months.
- Non-use of appropriate contraceptives in females of childbearing potential (e.g. condoms, intrauterine device \[IUD\], hormonal contraception for females, or a means of contraception for a particular patient considered adequate by the responsible investigator) during treatment.
- Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00609973
Start Date
May 1 2008
End Date
December 1 2011
Last Update
May 3 2013
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599