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Study Title and Description

Comparison of vancomycin, teicoplanin, metronidazole, and fusidic acid for the treatment 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 Comparison of vancomycin, teicoplanin, metronidazole, and fusidic acid for the treatment of Clostridium difficile-associated diarrhea.
Author Wenisch C., Parschalk B., Hasenhündl M., Hirschl AM., Graninger W.
Country Department of Infectious Diseases, University Hospital of Vienna, Austria.
Year 1996
Numbers Pubmed ID: 8722937
1353 (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: Austria Funding source: none stated
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Population / Age or Age Range / % Women / Ethnicity / Inclusion Criteria Population: Symptomatic adults hospitalized for a minimum of 5 days Mean age: 42 % women: 48 Inclusion criteria: age of >18 years and the presence of CDI. Diarrhea was defined as >3 loose stools per day. CDI was diagnosed on the basis of the results of a C. difficile toxin assay and/or endoscopic evidence of typical colitis, with the finding of granulocytes in stools
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Sample Size (N) / Intervention(s) / Control (s) / Study Duration N=126 Intervention 1: Metronidazole 500 mg 3 times/day (n=31) Intervention 2: Fusidic acid 500 mg 3 times/day (n=29) Intervention 3: Vancomycin 500 mg 3 times/day (n=31) Intervention 4: Teicoplanin (injection) 400 mg 2 times/day (n=28) Treatment duration: 10 days Followup period: 30 days
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Outcomes Evaluated a. Clinical cure, # of patients (defined as no loose stools, gastro- intestinal symptoms, or fever and normalization of serum levels of C-reactive protein and leukocyte counts) b. Clinical failure (defined as persistence of diarrhea after 6 days of treatment c. Clinical relapse (defined as the reappearance of CDI and other symptoms during the followup period) d. Adverse events
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Study Quality Allocation concealment: not defined Blinding: none stated, teicoplanin administered as an injection, the other drugs orally Intention-to-treat analysis: no Withdrawals and dropouts reported: 7 (6%)
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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 Metronidazole Comparison Measure Vancomycin vs. Metronidazole


Enter a numeric value or title (required) years

# Subjects 29 29 1.00
# Randomized 31 31 0.88
# Initially cured 1.14
# Assessed
Percentage 94 94
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 Metronidazole Comparison Measure Vancomycin vs. Metronidazole


Enter a numeric value or title (required) years

# Subjects 5 5 1.00
# Randomized 0.32
# Initially cured 29 29 3.09
# Assessed
Percentage 17 17
Outcome: All-cause mortality      Population: All Participants
Time Point Measure Vancomycin Metronidazole


Enter a numeric value or title (required) years

# Subjects 3 subjects died within first days of therapy (treatment groups not noted) 3 subjects died within first days of therapy (treatment groups not noted)
# Randomized
# 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 Metronidazole


6 days

# Subjects
# Randomized
# Initially cured
# Assessed
Percentage


30 days

# Subjects
# Randomized
# Initially cured
# Assessed
Percentage
Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Clearance of Organism (CO) / Toxin (CT) or Laboratory-confirmed-relapse (LR) / Persistence (P) for Evaluable Subjects      Population: Clearance of toxin Between-Arm Comparisons
Time Point Measure Vancomycin Metronidazole Comparison Measure Vancomycin vs. Metronidazole


6 days

# Subjects 22 22 1.00
# Randomized 0.73
# Initially cured 1.37
# Assessed 31 31
Percentage 71 71


30 days

# Subjects
# Randomized
# Initially cured
# Assessed
Percentage
Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)
Outcome: Clearance of Organism (CO) / Toxin (CT) or Laboratory-confirmed-relapse (LR) / Persistence (P) for Evaluable Subjects      Population: Laboratory-confirmed-relapse Between-Arm Comparisons
Time Point Measure Vancomycin Metronidazole Comparison Measure Vancomycin vs. Metronidazole


6 days

# Subjects
# Randomized
# Initially cured
# Assessed
Percentage


30 days

# Subjects 9 9 1.00
# Randomized 0.46
# Initially cured 2.18
# Assessed 31 31
Percentage 29 29
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 Metronidazole Comparison Measure Vancomycin vs. Metronidazole


Enter a numeric value or title (required) years

Mean 3.1 3.2 -0.65
Standard Deviation 1.1 1.1 0.45
0.10


Quality Dimensions
Dimension Value Notes Comments
Metronidazole trials - Allocation Concealment Not defined
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Metronidazole trials - Blinding None stated
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Metronidazole trials - Intention-to-Treat Analysis No
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Metronidazole trials - Withdrawals and Dropouts Reported 7 (6%) Based on all subjects, 4-arm trial
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Metronidazole trials - Study Quality Poor
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Vancomycin trials - Allocation Concealment Not defined
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Vancomycin trials - Blinding None stated
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Vancomycin trials - Intention-to-Treat Analysis No
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Vancomycin trials - Withdrawals and Dropouts Reported 7 (6%) Based on all subjects, 4-arm trial
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Vancomycin trials - Study Quality Poor
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Quality Rating
No quality rating data was found.