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Study Title and Description

Prospective study of oral teicoplanin versus oral vancomycin for therapy of pseudomembranous colitis and 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 study of oral teicoplanin versus oral vancomycin for therapy of pseudomembranous colitis and Clostridium difficile-associated diarrhea.
Author de Lalla F., Nicolin R., Rinaldi E., Scarpellini P., Rigoli R., Manfrin V., Tramarin A.
Country Department of Infectious Diseases, S. Bortolo Hospital, Vicenza, Italy.
Year 1992
Numbers Pubmed ID: 1444298
1354 (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 Teicoplanin
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Design Details
Question... Follow Up Answer Follow-up Answer
Region / Funding Source Region: Italy Funding source: none stated
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Population / Age or Age Range / % Women / Ethnicity / Inclusion Criteria Population: Symptomatic adult inpatients Mean age (range): 47 (18 to 83) % women: 70 Inclusion criteria: age of >18 years, presence of symptoms (diarrhea, sometimes combined with fever and abdominal pain), and stool culture and/or a rapid diagnostic test positive for C difficile and/or colonoscopic demonstration of the typical endoscopic picture of pseudomembranous colitis
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Sample Size (N) / Intervention(s) / Control (s) / Study Duration N=51 Intervention 1: Vancomycin 500 mg 4 times/day (n=24) Intervention 2: Teicoplanin 100 mg 2 times/day (n=27) Study duration: 10 days Followup period: 30 days
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Outcomes Evaluated a. Cure, # of patients (defined as elimination of symptoms and signs were) b. Failure, # patients (defined persistence of diarrhea after 6 days of treatment) c. Relapse (defined as reappearance of diarrhea and other symptoms in the 1-month followup period) d. All-cause mortality e. Adverse events
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Study Quality Allocation concealment: not defined Blinding: none stated Intention-to-treat analysis: no Withdrawals and dropouts reported: 5 (10%)
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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
Outcome: Clinical initial cure      Population: All Participants
Time Point Measure Vancomycin Teicoplanin


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# Subjects 20
# Randomized 24
# Initially cured
# Assessed
Percentage 83
Outcome: Clinical recurrence      Population: All Participants
Time Point Measure Vancomycin Teicoplanin


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# Subjects 4
# Randomized
# Initially cured 20
# Assessed
Percentage 20
Outcome: All-cause mortality      Population: All Participants
Time Point Measure Vancomycin Teicoplanin


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# Subjects 2 subjects died with 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: Persistence
Time Point Measure Vancomycin Teicoplanin


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# Subjects 9
# Randomized
# Initially cured
# Assessed 20
Percentage 45
Outcome: Time to resolution of diarrhea / clinical improvement      Population: All Participants
Time Point Measure Vancomycin Teicoplanin


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Mean 3.6
Standard Deviation 1.7


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
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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.