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Study Title and Description

Nitazoxanide for the treatment of Clostridium difficile colitis.



Key Questions Addressed
6 Key Question 6 - Standard Antibiotic treatments
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Primary Publication Information
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TitleData
Title Nitazoxanide for the treatment of Clostridium difficile colitis.
Author Musher DM., Logan N., Hamill RJ., Dupont HL., Lentnek A., Gupta A., Rossignol JF.
Country Medical Service, Infectious Disease Section, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas 77030, USA. daniel.musher@med.va.gov
Year 2006
Numbers Pubmed ID: 16838229
1350 (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 Metronidazole
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2 Nitazoxanide
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Design Details
Question... Follow Up Answer Follow-up Answer
Region / Funding Source Region: USA Funding source: Romark Pharmaceuticals
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Population / Age or Age Range / % Women / Ethnicity / Inclusion Criteria Population: Symptomatic adults, a substantial proportion had severe, comorbid conditions Mean age: 68 women: 24% Ethnicity: White 77%; black 17%; Hispanic 6% Inclusion criteria: inpatients >18 years of age with diarrhea (defined as •3 unformed stools within a 24-h period), an enzyme immunoassay result positive for C. difficile toxin, and •1of the following findings: fever, abdominal pain, or leukocytosis
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Sample Size (N) / Intervention(s) / Control (s) / Study Duration N=142 Intervention 1: Metronidazole 250 mg 4 times/day (n=44) Intervention 2: Nitazoxanide 500 mg 2 times/day for 7 days (n=49) Intervention 3: Nitazoxanide 500 mg 2 times/day (n=49) Treatment duration: 10 days unless noted Followup period: 31 days
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Outcomes Evaluated a. Response to therapy, assessed 3 ways: (1) time to resolution of symptoms of colitis; (2) complete clinical response at the end of 7 days of treatment, defined as return of normal stool pattern and absence of fever, abdominal pain, or leukocytosis, unless some other explanation was apparent; and (3) sustained clinical response 31 days after the beginning of treatment b. All-cause mortality c. Adverse events
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Study Quality Allocation concealment: not defined Blinding: double Intention-to-treat analysis: no Withdrawals and dropouts reported: 32 (23%)
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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) 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: Clinical initial cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Metronidazole Nitazoxanide Comparison Measure Metronidazole vs. Nitazoxanide


baseline N/A

# Subjects 28 68 0.92
# Randomized 44 98 0.71
# Initially cured 1.19
# Assessed
Percentage 64 69


7 days

Percentage 36
# Subjects 49
# Randomized
# Initially cured
# Assessed 73


10 days

Percentage 32
# Subjects 49
# Randomized
# Initially cured
# Assessed 65
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) 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 Metronidazole Nitazoxanide Comparison Measure Metronidazole vs. Nitazoxanide


baseline N/A

# Subjects 8 14 1.39
# Randomized 0.66
# Initially cured 28 68 2.93
# Assessed
Percentage 29 21


7 days

# Subjects 9
# Randomized
# Initially cured 36
# Assessed
Percentage


10 days

# Subjects 5
# Randomized
# Initially cured 32
# Assessed
Percentage 3
Outcome: All-cause mortality      Population: All Participants
Time Point Measure Metronidazole Nitazoxanide


Enter a numeric value or title (required) years

Percentage
# Subjects 1+/44 (A total of 13 deaths = 9% occurred, but only the 4 deaths above were denoted by treatment arm) 3+/98
# Randomized
# Initially cured
# Assessed
Outcome: Clearance of Organism (CO) / Toxin (CT) or Laboratory-confirmed-relapse (LR) / Persistence (P) for Evaluable Subjects      Population: All Participants
Time Point Measure Metronidazole Nitazoxanide


Enter a numeric value or title (required) years

Percentage
# Subjects NR NR
# Randomized
# Initially cured
# Assessed
Outcome: Time to resolution of diarrhea / clinical improvement      Population: All Participants
Time Point Measure Metronidazole Nitazoxanide


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 Not defined
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Metronidazole trials - Blinding Double
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Metronidazole trials - Intention-to-Treat Analysis No
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Metronidazole trials - Withdrawals and Dropouts Reported 32 (23%)
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Metronidazole trials - Study Quality Poor
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Vancomycin trials - Allocation Concealment Adequate
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Vancomycin trials - Blinding Double
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Vancomycin trials - Intention-to-Treat Analysis Partially, one subject removed
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Vancomycin trials - Withdrawals and Dropouts Reported 9 (18%)
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Vancomycin trials - Study Quality Good
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Quality Rating
No quality rating data was found.