Study Title and Description
Treatment with monoclonal antibodies against Clostridium difficile toxins.
Key Questions Addressed
|9||Key Question 9 - Probiotic or prebiotic interventions for prevention of initial and recurrent CDI|
Primary Publication Information
|Title||Treatment with monoclonal antibodies against Clostridium difficile toxins.|
|Author||Lowy I., Molrine DC., Leav BA., Blair BM., Baxter R., Gerding DN., Nichol G., Thomas WD., Leney M., Sloan S., Hay CA., Ambrosino DM.|
|Country||Medarex, Princeton, NJ, USA.|
Pubmed ID: 20089970
Secondary Publication Information
There are currently no secondary publications defined for this study.
Extraction Form: Key Question 4 - Probiotic or prebiotic interventions for prevention of initial and recurrent CDI (Table 20)
|Question... Follow Up||Answer||Follow-up Answer|
|Country / Study Design||United States and Canada Randomized controlled trial|
|Sample||200 inpatients and outpatients were 18 years of age with diarrhea associated with a positive stool test for CD toxin(s) in the 14 days prior to enrollment and who were receiving either metronidazole or vancomycin Mean age (range): 64 (20-101) years Gender: Male 34% White race: 88% Black race: 6% Severe disease at enrollment: 40%|
|Prevention of initial or recurrent Clostridium difficile infection?||Prevention of Recurrent Clostridium difficile infection|
|Intervention/Comparison and Method||Monoclonal antibodies: intravenous infusion of fully human monoclonal antibodies against C. difficile toxins A (CDA1) and B (CDB1) x 1 (n=101) Placebo (0.9% sodium chloride) x 1 (n=99) Recurrence of C. difficile infection, was defined as a new episode of diarrhea associated with a new positive stool toxin test after the resolution of the initial Clostridium difficile infection diarrheal episode and after discontinuation of metronidazole or vancomycin. Diarrhea was defined as three or more unformed stools per day for at least 2 consecutive days or more than six unformed stools in 1 day|
|C. difficile Diarrhea (Diarrhea and CD Toxin +)|
|Later Recurrence of CD Diarrhea||Incidence of laboratory documented Clostridium difficile infection - primary outcome): Monoclonal antibodies: 7/101 (7%); inpatient = 7/50, outpatient = 0/51 Placebo: 25/99 (25%); inpatient = 13/52, outpatient = 12/47, p=0.0004 Recurrent diarrhea With/without laboratory confirmation of Clostridium difficile infection and with/without antibiotic treatment for Clostridium difficile infection Monoclonal antibodies: 28/101 (28%) Placebo: 49/99 (50%), p=0.0022|
|Notes of Study Quality and Side Effects||Allocation concealment: not defined Blinding: double and independent statistician and data and safety monitoring board Intention-to-treat analysis: yes Withdrawals and dropouts adequately described: yes Adverse events reported in 14 patients (antibody group = 9; placebo = 5) during infusion and in 11 patients (antibody group = 6; placebo = 5) during 2-hour period after infusion. All AE noted to be mild to moderate (headache reported most frequently) Death: antibody group = 7; placebo = 8 (p=0.79)|
Results & Comparisons
No Results found.