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Study Title and Description

Oral bacitracin vs vancomycin therapy for Clostridium difficile-induced diarrhea. A randomized double-blind trial.



Key Questions Addressed
6 Key Question 6 - Standard Antibiotic treatments
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Primary Publication Information
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TitleData
Title Oral bacitracin vs vancomycin therapy for Clostridium difficile-induced diarrhea. A randomized double-blind trial.
Author Dudley MN., McLaughlin JC., Carrington G., Frick J., Nightingale CH., Quintiliani R.
Country -- Not Found --
Year 1986
Numbers Pubmed ID: 3521518
1356 (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 bacitracin
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Design Details
Question... Follow Up Answer Follow-up Answer
Region / Funding Source Region: USA Funding source: Upjohn Company
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Population / Age or Age Range / % Women / Ethnicity / Inclusion Criteria Population: Symptomatic adult inpatients Mean age: 69 % women: 60 (evaluable subjects (n=30) only for age and gender) Inclusion criteria: antibiotic associated diarrhea (•4 loose stools were passed for •2 consecutive days, signs and symptoms of C difficile-induced
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Sample Size (N) / Intervention(s) / Control (s) / Study Duration N=62 Intervention 1: Vancomycin 500 mg 4 times/day (n=31) Intervention 2: Bacitracin 25,000 mg 4 times/day (n=31) Study duration: 10 days Followup period: up to 60
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Outcomes Evaluated a. Treatment response (cure) based diarrhea resolution (defined as ”4 loose stools were passed for •2 consecutive days) b. Treatment failure (defined as diarrhea and other symptoms worsened and were crossed over to the alternative drug in a blinded manner. Patients worsening after 5 days of the crossed over therapy were considered failures
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Study Quality Allocation concealment: adequate (coded amber bottles prepared by pharmacy) Blinding: double Intention-to-treat analysis: no Withdrawals and dropouts reported: 32 (52%)
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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 Vancomycin bacitracin Comparison Measure Vancomycin vs. bacitracin


Enter a numeric value or title (required) years

# Subjects 15 12 0.87
# Randomized 23 16 0.58
# Initially cured 1.31
# Assessed
Percentage 65 75
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 bacitracin Comparison Measure Vancomycin vs. bacitracin


Enter a numeric value or title (required) years

# Subjects 3 5 0.48
# Randomized 0.14
# Initially cured 15 12 1.62
# Assessed
Percentage 20 42
Outcome: All-cause mortality      Population: All Participants
Time Point Measure Vancomycin bacitracin


Enter a numeric value or title (required) years

# Subjects 0 1
# Randomized 31 31
# Initially cured
# Assessed
Percentage 3
Outcome: Clearance of Organism (CO) / Toxin (CT) or Laboratory-confirmed-relapse (LR) / Persistence (P) for Evaluable Subjects      Population: All Participants
Time Point Measure Vancomycin bacitracin


Enter a numeric value or title (required) years

# Subjects
# Randomized
# Initially cured
# Assessed
Percentage
Outcome: Clearance of Organism (CO) / Toxin (CT) or Laboratory-confirmed-relapse (LR) / Persistence (P) for Evaluable Subjects      Population: Clearance of organism
Time Point Measure Vancomycin bacitracin


Enter a numeric value or title (required) years

# Subjects 11 4
# Randomized
# Initially cured
# Assessed 14 10
Percentage 79 40
Outcome: Clearance of Organism (CO) / Toxin (CT) or Laboratory-confirmed-relapse (LR) / Persistence (P) for Evaluable Subjects      Population: Clearance of toxin
Time Point Measure Vancomycin bacitracin


Enter a numeric value or title (required) years

# Subjects 12 5
# Randomized
# Initially cured
# Assessed 14 11
Percentage 86 45
Outcome: Time to resolution of diarrhea / clinical improvement      Population: All Participants
Time Point Measure Vancomycin bacitracin


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 Adequate
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Vancomycin trials - Blinding Double
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Vancomycin trials - Intention-to-Treat Analysis No
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Vancomycin trials - Withdrawals and Dropouts Reported 32 (52%)
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Vancomycin trials - Study Quality Fair
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Quality Rating
No quality rating data was found.