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Study Title and Description

Antibiotic-associated colitis due to Clostridium difficile: double-blind comparison of vancomycin with bacitracin.



Key Questions Addressed
6 Key Question 6 - Standard Antibiotic treatments
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Primary Publication Information
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TitleData
Title Antibiotic-associated colitis due to Clostridium difficile: double-blind comparison of vancomycin with bacitracin.
Author Young GP., Ward PB., Bayley N., Gordon D., Higgins G., Trapani JA., McDonald MI., Labrooy J., Hecker R.
Country -- Not Found --
Year 1985
Numbers Pubmed ID: 4043661
1357 (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: Australia Funding source: Upjohn Company and the McGauran Trust
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Population / Age or Age Range / % Women / Ethnicity / Inclusion Criteria Population: Symptomatic adult inpatients Mean age: 62 (gender not reported) Inclusion criteria: antibiotic associated diarrhea (•4 loose stools were passed for •2 consecutive days, signs and symptoms of C difficile-induced diarrhea and its cytotoxin
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Sample Size (N) / Intervention(s) / Control (s) / Study Duration N=42 Intervention 1: Vancomycin 125 mg 4 times/day (n=21) Intervention 2: Bacitracin 20,000 mg 4 times/day (n=21) Study duration: 7 days Followup period: 28 days
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Outcomes Evaluated a. Treatment response (cure) based diarrhea resolution (defined as <3 times/day by the time the last capsule was given. Day of resolution defined as first day of <3 stools, provide frequency did not go above >2) b. Treatment relapse c. Mean days to 50% improvement
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Study Quality Allocation concealment: adequate (identical red capsules and sealed codes held in pharmacy) Blinding: double Intention-to-treat analysis: yes for initial therapy Withdrawals and dropouts reported: all completed initial treatment
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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 Difference (RD) 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 18 16 1.13
# Randomized 21 21 0.84
# Initially cured 1.51
# Assessed
Percentage 86 76
Risk Difference (RD) 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 6 5 0.80
# Randomized 0.31
# Initially cured 18 12 2.04
# Assessed
Percentage 33 42
Outcome: All-cause mortality      Population: All Participants
Time Point Measure Vancomycin bacitracin


Enter a numeric value or title (required) years

# Subjects 0 0
# Randomized 21 21
# Initially cured
# Assessed
Percentage
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 17 11
# Randomized
# Initially cured
# Assessed 21 21
Percentage 81 52
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 15 10
# Randomized
# Initially cured
# Assessed 18 19
Percentage 83 53
95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) Weighted mean difference (WMD)
Outcome: Time to resolution of diarrhea / clinical improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure Vancomycin bacitracin Comparison Measure Vancomycin vs. bacitracin


Enter a numeric value or title (required) years

Mean 4.3 4.8 -1.59
Standard Deviation 1.8 1.8 0.59
-0.50


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 Yes for initial therapy
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Vancomycin trials - Withdrawals and Dropouts Reported None
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Vancomycin trials - Study Quality Good
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Quality Rating
No quality rating data was found.