Vancomycin vs. Nitazoxanide to Treat Recurrent C. Difficile Colitis

NCT00304889 | Completed

• 1 other identifier: H-18736
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the outcome of treatment with nitazoxanide vs. vancomycin for diarrheal disease due to Clostridium difficile in patients who have failed previous treatment with metronidazole.

Conditions

Clostridium Enterocolitis; Pseudomembranous Colitis; Antibiotic-Associated Colitis

Keywords

Clostridium difficile

Outcome Measures

Primary Outcomes (1)

• Days to symptom resolution

  Number of day to resolution to three formed or loose stools per day

  observation

Secondary Outcomes (1)

• side effects

  observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for C. difficile.

You may qualify if:

• Patients \>18 years of age
• clinical diagnosis of C. difficile associated disease, based on the new onset of diarrhea, abdominal discomfort, or otherwise unexplained fever or leukocytosis
• diagnosis of C. difficile colitis proven by positive assay for C. difficile toxin in feces
• disease has been treated, and the symptoms failed to respond to treatment with metronidazole, or symptoms recurred after the patient has completed a course of metronidazole therapy
• able to take oral medication

You may not qualify if:

• patients with other recognized causes of diarrhea or colitis
• women of child bearing age who are pregnant, breast feeding, or not using birth control
• patients of known causes of diarrhea, such as inflammatory bowel disease
• patients in whom diarrhea can not be evaluated, such as those with colostomy
• patients with renal insufficiency (BUN or creatinine \>3.0 times baseline)
• patients who are medically unstable, for example in an ICU and on medications to maintain blood pressure
• patients who are regarded as unlikely to survive for 3 months

Sponsors & Collaborators

• Michael E. DeBakey VA Medical Center: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Enterocolitis, Pseudomembranous

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Daniel M Musher, M.D.

  Houston VA Medical Center, Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 16, 2006
• First Posted: March 20, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: June 3, 2015

Record last verified: 2013-02

Locations

US (1)