Advanced Search

Study Preview



Study Title and Description

Prospective randomised trial of metronidazole versus vancomycin for Clostridium-difficile-associated diarrhoea and colitis.



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

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Prospective randomised trial of metronidazole versus vancomycin for Clostridium-difficile-associated diarrhoea and colitis.
Author Teasley DG., Gerding DN., Olson MM., Peterson LR., Gebhard RL., Schwartz MJ., Lee JT.
Country -- Not Found --
Year 1983
Numbers Pubmed ID: 6138597
1358 (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 Metronidazole
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Region / Funding Source Region: USA Funding source: Veterans Affairs and Searle Laboratories
  • Comments Comments (
    0
    ) |
Population / Age or Age Range / % Women / Ethnicity / Inclusion Criteria Population: Symptomatic inpatient adults Mean age: 65 % women: 1 Inclusion criteria: C difficile-associated diarrhea and its cytotoxin. All patients had received antimicrobial treatment 14-55 days prior to diarrhea
  • Comments Comments (
    0
    ) |
Sample Size (N) / Intervention(s) / Control (s) / Study Duration N=101 Intervention 1: Vancomycin 500 mg 4 times/day (n=56) Intervention 2: Metronidazole 250 mg 4 times/day (n=45) Study duration: 10 days Followup period: 21 days
  • Comments Comments (
    0
    ) |
Outcomes Evaluated a. Cure (defined as diarrhea resolved within 6 days of treatment, toleration of complete treatment course, and no relapse in the 21-day followup period) b. Treatment response based diarrhea resolution (defined as <2 stools formed /day) c. Treatment failure (defined as ”4 loose stools/day after 6 days of treatment. d. Treatment relapse (defined as recurrence with 21 days of diarrhea with ”4 loose stools/day for a minimum of 2 days)
  • Comments Comments (
    0
    ) |
Study Quality Allocation concealment: not defined Blinding: none stated Intention-to-treat analysis: no Withdrawals and dropouts reported: 7 (7%)
  • 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 Metronidazole Comparison Measure Vancomycin vs. Metronidazole


Enter a numeric value or title (required) years

# Subjects 51 39 1.05
# Randomized 56 45 0.91
# Initially cured 1.21
# Assessed
Percentage 91 87
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 Metronidazole Comparison Measure Vancomycin vs. Metronidazole


Enter a numeric value or title (required) years

# Subjects 6 2 0.53
# Randomized 0.19
# Initially cured 51 39 1.50
# Assessed
Percentage 12 5
Outcome: All-cause mortality      Population: All Participants
Time Point Measure Vancomycin Metronidazole


Enter a numeric value or title (required) years

# Subjects 2 0
# Randomized 56 45
# Initially cured
# Assessed
Percentage 4
Risk Difference (RD) 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: persistence Between-Arm Comparisons
Time Point Measure Vancomycin Metronidazole Comparison Measure Vancomycin vs. Metronidazole


21 years

# Subjects 11 14 0.64
# Randomized 0.33
# Initially cured 1.23
# Assessed 43 35
Percentage 26 40
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 2.8 2.4 -0.35
Standard Deviation 1.8 1.9 1.15
-0.40


Quality Dimensions
Dimension Value Notes Comments
Metronidazole trials - Allocation Concealment Not defined
  • Comments Comments (
    0
    ) |
Metronidazole trials - Blinding None stated
  • Comments Comments (
    0
    ) |
Metronidazole trials - Intention-to-Treat Analysis No
  • Comments Comments (
    0
    ) |
Metronidazole trials - Withdrawals and Dropouts Reported 7 (7%)
  • Comments Comments (
    0
    ) |
Metronidazole trials - Study Quality Poor
  • Comments Comments (
    0
    ) |
Vancomycin trials - Allocation Concealment Not defined
  • Comments Comments (
    0
    ) |
Vancomycin trials - Blinding None stated
  • Comments Comments (
    0
    ) |
Vancomycin trials - Intention-to-Treat Analysis No
  • Comments Comments (
    0
    ) |
Vancomycin trials - Withdrawals and Dropouts Reported 7 (7%)
  • Comments Comments (
    0
    ) |
Vancomycin trials - Study Quality Poor
  • Comments Comments (
    0
    ) |

Quality Rating
No quality rating data was found.