Ciprofloxacin for the Prevention of Postoperative Endoscopic Recurrence in Crohn's Disease

NCT00609973 | Completed Phase 2 Results DMC

• 1 other identifier: Cipro 1.1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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 patients and is a serious limitation of surgical management. Therapeutic options to maintain postoperative clinical remission are urgently needed. Several drugs including mesalazine, antibiotics (metronidazole, ornidazole) and azathioprine or 6-mercaptopurine have been studied in the past. But the efficacy is very limited (mesalazine), overshadowed by intolerability during long-term therapy (metronidazole, ornidazole) or inconclusive (azathioprine or 6-mercaptopurine). Research demonstrating the absence of inflammation in patients with diverting ileostomy and the clinical benefit of a postoperative antibiotic therapy using metronidazole or ornidazole implicates a role of the resident bacterial flora in the postoperative relapse. Ciprofloxacin has a broad antibacterial spectrum. More interestingly it also suppresses E. coli strains, which can be found in high numbers in early and chronic ileal lesions of Crohn's disease patients Ciprofloxacin has demonstrated beneficial effects in the therapy of inflammatory bowel diseases, but the available data of the effectiveness of ciprofloxacin allow only a very limited judgement of the safety and tolerability of a 6 months therapy of ciprofloxacin. Therefore an exploratory multicenter prospective, placebo-controlled trial is planned to analyze the safety and tolerability of a 6 months therapy with ciprofloxacin compared to placebo in 40 patients (randomly assigned in a 1:1 ratio) undergoing ileocecal resection (or resection of parts of the colon). If this therapeutic regimen demonstrates tolerability, a second larger study improving the superiority of ciprofloxacin versus placebo can be initiated.

Conditions

Crohn's Disease

Keywords

Postoperative recurrence, inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of Ciprofloxacin

  Adverse events (AE) Discontinuation of study drug due to probably study drug related AE

  6 Months

Secondary Outcomes (1)

• Endoscopic Recurrence Under Postoperative Treatment With Study Medication at 6 Months

  6 months

Study Arms (2)

A

ACTIVE COMPARATOR

Ciprofloxacin 500 mg bid

Drug: Ciprofloxacin

B

PLACEBO COMPARATOR

Placebo bid

Drug: Placebo

Interventions

Ciprofloxacin DRUG

Ciprofloxacin 500 mg oral bid for 6 months

A

Placebo DRUG

Placebo bid for 6 months

B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Man or woman between 18 and 70 years of age.
• Diagnosis of Crohn's disease confirmed during index surgery.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Crohn's and Colitis Foundation: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Hans Herfarth
• Organization: University of North Carolina

hherf@med.unc.edu

9199666806

Study Officials

• Hans H Herfarth, MD, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 7, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 3, 2013
• Results First Posted: May 3, 2013

Record last verified: 2013-03

Locations

US (1)