Advanced Search

Study Preview



Study Title and Description

Randomised controlled trial of vancomycin for pseudomembranous colitis and postoperative diarrhoea.



Key Questions Addressed
6 Key Question 6 - Standard Antibiotic treatments
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Randomised controlled trial of vancomycin for pseudomembranous colitis and postoperative diarrhoea.
Author Keighley MR., Burdon DW., Arabi Y., Williams JA., Thompson H., Youngs D., Johnson M., Bentley S., George RH., Mogg GA.
Country -- Not Found --
Year 1978
Numbers Pubmed ID: 367509
1359 (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
  • Comments Comments (
    0
    ) |
2 placebo
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Region / Funding Source Region: UK Funding source: none stated
  • Comments Comments (
    0
    ) |
Population / Age or Age Range / % Women / Ethnicity / Inclusion Criteria Population: Symptomatic adult inpatients. Subjects with evidence of cytotoxins separated with from subjects with C difficile on culture Age and gender not reported Inclusion criteria: postoperative diarrhea (•3 loose stools/day or colostomy output >1 liter/day. All patients had received antimicrobial treatment prior to diarrhea
  • Comments Comments (
    0
    ) |
Sample Size (N) / Intervention(s) / Control (s) / Study Duration N=44 Intervention: Vancomycin 125 mg 4 times/day (n=22) Control: Placebo (n=22) Study duration: 5 days Followup period: unclear, up to 29 days in the control group
  • Comments Comments (
    0
    ) |
Outcomes Evaluated a. Treatment response based diarrhea resolution (defined as normal stool, improved, same, or worse. Normal was defined as 1 solid stool/day, the others were not described) b. Adverse events
  • Comments Comments (
    0
    ) |
Study Quality Allocation concealment: adequate (identical looking placebo and based code held in pharmacy) Blinding: unclear if double ("identical looking placebo") Intention-to-treat analysis: yes Withdrawals and dropouts reported: all completed initial treatment
  • Comments Comments (
    0
    ) |
Source of Study Trials Included in Cochrane Systematic Review24
  • Comments Comments (
    0
    ) |


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 placebo Comparison Measure Vancomycin vs. placebo


Enter a numeric value or title (required) years

# Subjects 9 1 6.75
# Randomized 12 9 1.03
# Initially cured 44.08
# Assessed
Percentage 75 11
Outcome: Clinical recurrence      Population: All Participants
Time Point Measure Vancomycin placebo


Enter a numeric value or title (required) years

# Subjects NR NR
# Randomized
# Initially cured
# Assessed
Percentage
Outcome: All-cause mortality      Population: All Participants
Time Point Measure Vancomycin placebo


Enter a numeric value or title (required) years

# Subjects 0 "colitis" 0 "colitis"
# Randomized 12 12
# 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 placebo


Enter a numeric value or title (required) years

# Subjects 11 1
# Randomized
# Initially cured
# Assessed 12 9
Percentage 92 11
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 placebo


Enter a numeric value or title (required) years

# Subjects 12 3
# Randomized
# Initially cured
# Assessed 12 9
Percentage 100 33
Outcome: Time to resolution of diarrhea / clinical improvement      Population: All Participants
Time Point Measure Vancomycin placebo


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
  • Comments Comments (
    0
    ) |
Metronidazole trials - Blinding
  • Comments Comments (
    0
    ) |
Metronidazole trials - Intention-to-Treat Analysis
  • Comments Comments (
    0
    ) |
Metronidazole trials - Withdrawals and Dropouts Reported
  • Comments Comments (
    0
    ) |
Metronidazole trials - Study Quality
  • Comments Comments (
    0
    ) |
Vancomycin trials - Allocation Concealment Adequate
  • Comments Comments (
    0
    ) |
Vancomycin trials - Blinding Unclear ("identical placebo")
  • Comments Comments (
    0
    ) |
Vancomycin trials - Intention-to-Treat Analysis Yes
  • Comments Comments (
    0
    ) |
Vancomycin trials - Withdrawals and Dropouts Reported All completed initial treatment
  • Comments Comments (
    0
    ) |
Vancomycin trials - Study Quality Good
  • Comments Comments (
    0
    ) |

Quality Rating
No quality rating data was found.