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Study Title and Description

Prospective, randomized inpatient study of oral metronidazole versus oral metronidazole and rifampin for treatment of primary episode of Clostridium difficile-associated diarrhea.



Key Questions Addressed
6 Key Question 6 - Standard Antibiotic treatments
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Primary Publication Information
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TitleData
Title Prospective, randomized inpatient study of oral metronidazole versus oral metronidazole and rifampin for treatment of primary episode of Clostridium difficile-associated diarrhea.
Author Lagrotteria D., Holmes S., Smieja M., Smaill F., Lee C.
Country Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Year 2006
Numbers Pubmed ID: 16886144
1349 (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 Metronidazole
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2 Metronidazole plus rifampin
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Design Details
Question... Follow Up Answer Follow-up Answer
Region / Funding Source Region: Canada Funding source: The Physicians’ Services Incorporated Foundation
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Population / Age or Age Range / % Women / Ethnicity / Inclusion Criteria Population: Symptomatic adults (95% inpatients and 5% outpatients) Mean age: 69 years women: 59% Inclusion criteria: diagnosis of CDI on the basis of the Society for Healthcare Epidemiology of America definition, laboratory confirmation of the presence of C. difficile toxins A and B using an enzyme immunoassay, and no other etiology for diarrhea
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Sample Size (N) / Intervention(s) / Control (s) / Study Duration N=39 Intervention 1: Metronidazole 500 mg 3 times/day (n=20) Intervention 2: Metronidazole 500 mg 3 times/day and rifampin 300 mg 2 times/day (n=19) Treatment duration: 10 days Followup period: 30 days
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Outcomes Evaluated a. Clinical improvement (cure) at study day 10, # (%) of patients (defined as becoming asymptomatic during the treatment course. Failure defined as persistent symptoms and signs after 10 days of antimicrobial therapy) b. Experienced relapse by study day 40, # (%) of patients (defined as recurrence of diarrhea in the followup period for those patients who initially experienced a clinical cure) c. Laboratory-confirmed relapse by study day 40, # of patients d. Time to clinical improvement (days) e. Time to relapse (days) f. All-cause mortality g. Adverse events
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Study Quality Allocation concealment: unclear (numbered packages) Blinding: single (study staff) Intention-to-treat analysis: yes Withdrawals and dropouts reported: 7 (18%)
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Source of Study Trials Included in Cochrane Systematic Review24
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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 Metronidazole Metronidazole plus rifampin Comparison Measure Metronidazole vs. Metronidazole plus rifampin


Enter a numeric value or title (required) years

# Subjects 13 12 1.03
# Randomized 20 19 0.64
# Initially cured 1.65
# Assessed
Percentage 65 63
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 Metronidazole Metronidazole plus rifampin Comparison Measure Metronidazole vs. Metronidazole plus rifampin


Enter a numeric value or title (required) years

# Subjects 5 5 0.92
# Randomized 0.35
# Initially cured 13 12 2.41
# Assessed
Percentage 38 42
Outcome: All-cause mortality      Population: All Participants
Time Point Measure Metronidazole Metronidazole plus rifampin


Enter a numeric value or title (required) years

# Subjects 1 6
# Randomized 20 19
# Initially cured
# Assessed
Percentage 5 32
Outcome: Clearance of Organism (CO) / Toxin (CT) or Laboratory-confirmed-relapse (LR) / Persistence (P) for Evaluable Subjects      Population: Laboratory-confirmed-relapse
Time Point Measure Metronidazole Metronidazole plus rifampin


Enter a numeric value or title (required) years

# Subjects 2 4
# Randomized
# Initially cured
# Assessed
Percentage
P-Value
Outcome: Time to resolution of diarrhea / clinical improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure Metronidazole Metronidazole plus rifampin Comparison Measure Metronidazole vs. Metronidazole plus rifampin


Enter a numeric value or title (required) years

Mean 6.6 7.0 0.73
Standard Deviation NR NR


Quality Dimensions
Dimension Value Notes Comments
Metronidazole trials - Allocation Concealment Unclear (numbered packages but no further detail)
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Metronidazole trials - Blinding Single (study staff)
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Metronidazole trials - Intention-to-Treat Analysis Yes
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Metronidazole trials - Withdrawals and Dropouts Reported 7 (18%)
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Metronidazole trials - Study Quality Fair
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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.