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A fully humanized monoclonal antibody infusion given along with antibiotics decreased the rate of recurrent Clostridium difficile infections by 72%, compared with placebo in a phase II trial.
The active infusion, which contained antibodies against C. difficile toxins A and B, was significantly better than placebo regardless of whether patients had experienced one or multiple previous infections and regardless of whether they were infected with the epidemic or nonepidemic strain, Dr. Israel Lowy and his colleagues reported (N. Engl. J. Med. 2010;362:197-205).
The placebo-controlled, randomized trial included 200 patients who had experienced diarrhea associated with a positive C. difficile stool test within 14 days of enrollment. All were taking either metronidazole or vancomycin at baseline. Their mean age was 63 years, although the range was wide (20-101 years), said Dr. Lowy, senior director of clinical science and infectious disease at Medarex, the company developing the antibody, and his colleagues.
Patients in the active group received a 2-hour infusion of 200 mL normal saline containing 10 mg of C. difficile antibody CDA1 and 10 mg of antibody CDB1 per kilogram of body weight. Patients in the placebo group received an infusion of 200 mL normal saline.
The patients recorded their stool count daily over the 84-day study. The primary end point was lab-confirmed recurrence of C. difficile infection. Secondary end points included the days until resolution of the initial infection, severity of the initial infection, and antibiotic failure.
Recurrence of infection occurred in significantly fewer patients in the active group than in the placebo group (7% vs. 25%). Recurrent diarrhea also occurred in significantly fewer patients in the active group (28% vs. 50%).
The antibody infusion did not significantly affect the severity of diarrhea during the initial episode, nor the number of days until the initial episode resolved. It also had no significant effect on antibiotic failure.
Disclosures: The study was sponsored by Medarex and MassBioLogics. Dr. Lowy is a patent holder of the antibody infusion. Dr. Lowy and several coauthors are Medarex employees and coinventors of the infusion. One coauthor received research funds from MassBioLogics.
A fully humanized monoclonal antibody infusion given along with antibiotics decreased the rate of recurrent Clostridium difficile infections by 72%, compared with placebo in a phase II trial.
The active infusion, which contained antibodies against C. difficile toxins A and B, was significantly better than placebo regardless of whether patients had experienced one or multiple previous infections and regardless of whether they were infected with the epidemic or nonepidemic strain, Dr. Israel Lowy and his colleagues reported (N. Engl. J. Med. 2010;362:197-205).
The placebo-controlled, randomized trial included 200 patients who had experienced diarrhea associated with a positive C. difficile stool test within 14 days of enrollment. All were taking either metronidazole or vancomycin at baseline. Their mean age was 63 years, although the range was wide (20-101 years), said Dr. Lowy, senior director of clinical science and infectious disease at Medarex, the company developing the antibody, and his colleagues.
Patients in the active group received a 2-hour infusion of 200 mL normal saline containing 10 mg of C. difficile antibody CDA1 and 10 mg of antibody CDB1 per kilogram of body weight. Patients in the placebo group received an infusion of 200 mL normal saline.
The patients recorded their stool count daily over the 84-day study. The primary end point was lab-confirmed recurrence of C. difficile infection. Secondary end points included the days until resolution of the initial infection, severity of the initial infection, and antibiotic failure.
Recurrence of infection occurred in significantly fewer patients in the active group than in the placebo group (7% vs. 25%). Recurrent diarrhea also occurred in significantly fewer patients in the active group (28% vs. 50%).
The antibody infusion did not significantly affect the severity of diarrhea during the initial episode, nor the number of days until the initial episode resolved. It also had no significant effect on antibiotic failure.
Disclosures: The study was sponsored by Medarex and MassBioLogics. Dr. Lowy is a patent holder of the antibody infusion. Dr. Lowy and several coauthors are Medarex employees and coinventors of the infusion. One coauthor received research funds from MassBioLogics.
A fully humanized monoclonal antibody infusion given along with antibiotics decreased the rate of recurrent Clostridium difficile infections by 72%, compared with placebo in a phase II trial.
The active infusion, which contained antibodies against C. difficile toxins A and B, was significantly better than placebo regardless of whether patients had experienced one or multiple previous infections and regardless of whether they were infected with the epidemic or nonepidemic strain, Dr. Israel Lowy and his colleagues reported (N. Engl. J. Med. 2010;362:197-205).
The placebo-controlled, randomized trial included 200 patients who had experienced diarrhea associated with a positive C. difficile stool test within 14 days of enrollment. All were taking either metronidazole or vancomycin at baseline. Their mean age was 63 years, although the range was wide (20-101 years), said Dr. Lowy, senior director of clinical science and infectious disease at Medarex, the company developing the antibody, and his colleagues.
Patients in the active group received a 2-hour infusion of 200 mL normal saline containing 10 mg of C. difficile antibody CDA1 and 10 mg of antibody CDB1 per kilogram of body weight. Patients in the placebo group received an infusion of 200 mL normal saline.
The patients recorded their stool count daily over the 84-day study. The primary end point was lab-confirmed recurrence of C. difficile infection. Secondary end points included the days until resolution of the initial infection, severity of the initial infection, and antibiotic failure.
Recurrence of infection occurred in significantly fewer patients in the active group than in the placebo group (7% vs. 25%). Recurrent diarrhea also occurred in significantly fewer patients in the active group (28% vs. 50%).
The antibody infusion did not significantly affect the severity of diarrhea during the initial episode, nor the number of days until the initial episode resolved. It also had no significant effect on antibiotic failure.
Disclosures: The study was sponsored by Medarex and MassBioLogics. Dr. Lowy is a patent holder of the antibody infusion. Dr. Lowy and several coauthors are Medarex employees and coinventors of the infusion. One coauthor received research funds from MassBioLogics.