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Study Title and Description

Treatment of antibiotic-associated Clostridium difficile colitis with oral vancomycin: comparison of two dosage regimens.



Key Questions Addressed
6 Key Question 6 - Standard Antibiotic treatments
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Primary Publication Information
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TitleData
Title Treatment of antibiotic-associated Clostridium difficile colitis with oral vancomycin: comparison of two dosage regimens.
Author Fekety R., Silva J., Kauffman C., Buggy B., Deery HG.
Country Department of Internal Medicine, University of Michigan Medical Center, Ann Arbor 48109-0378.
Year 1989
Numbers Pubmed ID: 2910090
1355 (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 high-dose
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2 Vancomycin low-dose
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Design Details
Question... Follow Up Answer Follow-up Answer
Region / Funding Source Region: USA Funding source: NIH and Upjohn Company
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Population / Age or Age Range / % Women / Ethnicity / Inclusion Criteria Population: Moderately or severely ill symptomatic inpatients adults (plus one infant) Mean age/range: 54 (1 to 76) % women: gender not reported Inclusion criteria: antibiotic associated diarrhea plus at least one stool specimen that demonstrated both C difficile and its cytotoxin. All patients were moderately or severely ill, or unresponsive to supportive therapy (patients with mild illness as judged physicians were treated supportively, and not entered into the study)
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Sample Size (N) / Intervention(s) / Control (s) / Study Duration N=56 Intervention 1: Vancomycin 500 mg 4 times/day (n=22) Intervention 2: Vancomycin 125 mg 4 times/day (n=24) Study duration: 10 days Followup period: up to 6 weeks after treatment
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Outcomes Evaluated a. Treatment response (cure) based diarrhea resolution (defined as patients stating their bowel function is normal, or when they were having ”3 movements a day and their stools were semiformed) Patients whose diarrhea ceased within 7 days after treatment were considered to have a good response; patients whose diarrhea ceased but after 7 days of treatment were considered simply to have responded b. Mean duration of symptoms, days c. Adverse events
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Study Quality Allocation concealment: not defined Blinding: physicians were blinded to treatment assignment Intention-to-treat analysis: no Withdrawals and dropouts reported: 10 (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 Vancomycin high-dose Vancomycin low-dose Comparison Measure Vancomycin high-dose vs. Vancomycin low-dose


Enter a numeric value or title (required) years

# Subjects 22 24 0.92
# Randomized 28 28 0.72
# Initially cured 1.17
# Assessed
Percentage 79 86
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 high-dose Vancomycin low-dose Comparison Measure Vancomycin high-dose vs. Vancomycin low-dose


Enter a numeric value or title (required) years

# Subjects 4 5 0.87
# Randomized 0.27
# Initially cured 22 24 2.84
# Assessed
Percentage 18 21
Outcome: All-cause mortality      Population: All Participants
Time Point Measure Vancomycin high-dose Vancomycin low-dose


Enter a numeric value or title (required) years

# Subjects 1 1
# Randomized 28 28
# 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 high-dose Vancomycin low-dose


Enter a numeric value or title (required) years

# Subjects 4 5
# Randomized
# Initially cured
# Assessed 10 9
Percentage 40 56
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 high-dose Vancomycin low-dose Comparison Measure Vancomycin high-dose vs. Vancomycin low-dose


Enter a numeric value or title (required) years

Mean 4.3 3.8 -0.44
Standard Deviation 1.8 1.4 1.44
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
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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.