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Study Title and Description

Nitazoxanide versus vancomycin in Clostridium difficile infection: a randomized, double-blind study.



Key Questions Addressed
6 Key Question 6 - Standard Antibiotic treatments
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Primary Publication Information
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TitleData
Title Nitazoxanide versus vancomycin in Clostridium difficile infection: a randomized, double-blind study.
Author Musher DM., Logan N., Bressler AM., Johnson DP., Rossignol JF.
Country Infectious Disease Section, The Medical Care Line, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas 77030, USA. daniel.musher@med.va.gov
Year 2009
Numbers Pubmed ID: 19133801
1347 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Key Question 3 - Standard Antibiotic treatments (Tables 9-18, C4-C6)
Arms
Number Title Description Comments
1 Vancomycin
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2 Nitazoxanide
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Design Details
Question... Follow Up Answer Follow-up Answer
Region / Funding Source Region: USA Funding source: Department of Veterans Affairs
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Population / Age or Age Range / % Women / Ethnicity / Inclusion Criteria Population: Mild or severe symptomatic inpatient adults with comorbid conditions Mean age: 63 % women: 35 Ethnicity: White 69%; black 31% (45% in nitazoxanide group, 19% in vancomycin group) Inclusion criteria: EIA results positive for C. difficile toxin (Premier Toxins A & B; Meridian Bioscience), •3 loose stools within 24 h and •1 of the following additional findings: fever (temperature, 138.37C), abdominal pain, and/or leukocytosis Severity: patients with •2 points were considered to have severe CDI based on an assessment score developed for this study. One point each was given for age •60 years, >7 stools/day, temperature >38.3°C, albumin level <2.5 mg/dL, or peripheral WBC count >15,000 cells/mm3
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Sample Size (N) / Intervention(s) / Control (s) / Study Duration N=50 (severe 41%, n=20) Intervention 1: Vancomycin 125 mg 4 times/day (n=27) Intervention 2: Nitazoxanide 500 mg 2 times/day + placebo pill (n=23) Treatment duration: 10 days Followup period: 21 days
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Outcomes Evaluated a. End-of-treatment response (cure), # of patients (defined as complete resolution of all symptoms and signs attributable to CDI during the 3 days after completion of therapy) b. Relapse, # of patients (defined as a return of symptoms after an initial response but within 31 days after the onset of treatment with C. difficile toxin detected in stool by EIA or patient was re- treated empirically for CDI and responded to treatment. c. All-cause mortality d. Adverse events
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Study Quality Allocation concealment: adequate (sequentially numbered identical packages) Blinding: double Intention-to-treat analysis (all subjects randomized included in the analyses): partially, one subject was found to have IBD (an exclusion criteria) and was removed Withdrawals and dropouts reported: 9 (18%)
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Source of Study Newly Identified Trials
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Baseline Characteristics
No baseline characteristics have been defined for this extraction form.



Results & Comparisons


Results Data
Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Clinical initial cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Vancomycin Nitazoxanide Comparison Measure Vancomycin vs. Nitazoxanide


Enter a numeric value or title (required) years

# Subjects 20 17 1.00
# Randomized 27 23 0.72
# Initially cured 1.39
# Assessed
Percentage 74 74
Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Clinical initial cure      Population: Severe disease Between-Arm Comparisons
Time Point Measure Vancomycin Nitazoxanide Comparison Measure Vancomycin vs. Nitazoxanide


Enter a numeric value or title (required) years

# Subjects 7 8 0.88
# Randomized 10 10 0.53
# Initially cured 1.46
# Assessed
Percentage 70 80
Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Clinical recurrence      Population: All Participants Between-Arm Comparisons
Time Point Measure Vancomycin Nitazoxanide Comparison Measure Vancomycin vs. Nitazoxanide


Enter a numeric value or title (required) years

# Subjects 2 1 1.70
# Randomized 20 17 0.17
# Initially cured 17.16
# Assessed
Percentage 10 6
Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Clinical recurrence      Population: Severe disease Between-Arm Comparisons
Time Point Measure Vancomycin Nitazoxanide Comparison Measure Vancomycin vs. Nitazoxanide


Enter a numeric value or title (required) years

# Subjects 1 1 1.00
# Randomized 10 10 0.07
# Initially cured 13.87
# Assessed
Percentage 10 10
Outcome: All-cause mortality      Population: All Participants
Time Point Measure Vancomycin Nitazoxanide


Enter a numeric value or title (required) years

# Subjects
# Randomized
# Initially cured
# Assessed
Percentage overall 4% (2/49 subjects) (treatment groups not noted) overall 4% (2/49 subjects) (treatment groups not noted)
Outcome: Clearance of Organism (CO) / Toxin (CT) or Laboratory-confirmed-relapse (LR) / Persistence (P) for Evaluable Subjects      Population: All Participants
Time Point Measure Vancomycin Nitazoxanide


Enter a numeric value or title (required) years

# Subjects NR NR
# Randomized
# Initially cured
# Assessed
Percentage
Outcome: Time to resolution of diarrhea / clinical improvement      Population: All Participants
Time Point Measure Vancomycin Nitazoxanide


Enter a numeric value or title (required) years

Mean NR NR
Standard Deviation NR NR


Quality Dimensions
Dimension Value Notes Comments
Metronidazole trials - Allocation Concealment
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Metronidazole trials - Blinding
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Metronidazole trials - Intention-to-Treat Analysis
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Metronidazole trials - Withdrawals and Dropouts Reported
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Metronidazole trials - Study Quality
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Vancomycin trials - Allocation Concealment
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Vancomycin trials - Blinding
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Vancomycin trials - Intention-to-Treat Analysis
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Vancomycin trials - Withdrawals and Dropouts Reported
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Vancomycin trials - Study Quality
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Quality Rating
No quality rating data was found.