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Study Title and Description

A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity.



Key Questions Addressed
6 Key Question 6 - Standard Antibiotic treatments
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Primary Publication Information
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TitleData
Title A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity.
Author Zar FA., Bakkanagari SR., Moorthi KM., Davis MB.
Country University of Illinois at Chicago, Chicago, IL 60612-7323, USA. fazar@uic.edu
Year 2007
Numbers Pubmed ID: 17599306
1348 (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 Metronidazole
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Design Details
Question... Follow Up Answer Follow-up Answer
Region / Funding Source Region: USA Funding source: none stated
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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: 58 (47% <60 years) % women: 45 Inclusion criteria: Clostridium difficile- associated diarrhea (CDI), testing positive for C. difficile cytotoxin 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, temperature >38.3°C, albumin level <2.5 mg/dL, or peripheral WBC count >15,000 cells/mm3 within 48 h of enrollment. Two points were given for endoscopic evidence of pseudo-membranous colitis or treatment in the intensive care. All patients had received antimicrobial treatment prior to onset of CDI (>90% within 14 days)
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Sample Size (N) / Intervention(s) / Control (s) / Study Duration N=172 (mild 54%, severe 46% based on 150 patients completing trial) Intervention 1: Vancomycin (liquid) 125 mg 4 times/day + placebo pill (n=82) Intervention 2: Metronidazole (oral) 250 mg 4 times/day plus placebo liquid (n=90) Treatment duration: 10 days Followup period: 21 days
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Outcomes Evaluated a. Cure, # of patients (defined as resolution of diarrhea by day 6 of treatment and a negative result of a C. difficile toxin A assay at days 6 and 10 of treatment) b. Relapse, # of patients (defined as recurrence of C. difficile toxin A-positive diarrhea by day 21 after initial cure) c. All-cause mortality
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Study Quality Allocation concealment: adequate (controlled by pharmacy) Blinding: double Intention-to-treat analysis: no, completers only Withdrawals and dropouts reported: 22 (13%)
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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
Odds Ratio (OR) 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 Metronidazole Comparison Measure Vancomycin vs. Metronidazole


Enter a numeric value or title (required) years

# Subjects 69 66 1.15
# Randomized 82 90 0.98
Percentage 84 73 1.34
Odds Ratio (OR) 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 Metronidazole Comparison Measure Vancomycin vs. Metronidazole


Enter a numeric value or title (required) years

# Subjects 30 29 1.20
# Randomized 38 44 0.92
Percentage 79 66 1.57
Odds Ratio (OR) 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 Metronidazole Comparison Measure Vancomycin vs. Metronidazole


Enter a numeric value or title (required) years

# Subjects 5 9 2.29
# Initially cured 69 66 0.49
Percentage 7 14 10.76
Odds Ratio (OR) 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 Metronidazole Comparison Measure Vancomycin vs. Metronidazole


Enter a numeric value or title (required) years

# Subjects 5 5 0.48
# Initially cured 29 29 0.13
Percentage 17 17 1.75
Outcome: All-cause mortality      Population: All Participants
Time Point Measure Vancomycin Metronidazole


Enter a numeric value or title (required) years

N Enrolled 3/82 5/90
Percentage 4 6
Outcome: Clearance of Organism (CO) / Toxin (CT) or Laboratory-confirmed-relapse (LR) / Persistence (P) for Evaluable Subjects      Population: All Participants
Time Point Measure Vancomycin Metronidazole


Enter a numeric value or title (required) years

Percentage NR NR
# Subjects NR NR
# Assessed NR NR
95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) WMD
Outcome: Time to resolution of diarrhea / clinical improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure Vancomycin Metronidazole Comparison Measure Vancomycin vs. Metronidazole


Enter a numeric value or title (required) years

Percentage
Mean NR NR


Quality Dimensions
Dimension Value Notes Comments
Metronidazole trials - Allocation Concealment Adequate
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Metronidazole trials - Blinding Double
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Metronidazole trials - Intention-to-Treat Analysis Completers only
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Metronidazole trials - Withdrawals and Dropouts Reported 22 (13%)
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Metronidazole trials - Study Quality Fair
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Vancomycin trials - Allocation Concealment Adequate
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Vancomycin trials - Blinding Double
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Vancomycin trials - Intention-to-Treat Analysis No, completers only
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Vancomycin trials - Withdrawals and Dropouts Reported 22 (13%)
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Vancomycin trials - Study Quality Fair
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Quality Rating
No quality rating data was found.