Conditions: Clostridium Difficile-associated Diarrhea (CDAD)
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 14
Healthy volunteers: no

Brief summary:
In this trial, eligible patients will be randomly assigned to receive a single dose of 400 mg/kg of IVIG or a normal saline infusion as placebo over 4-6 hours, in addition to their usual medications for CDAD. We expect to enroll approximately 40 patients over a period of two years from UPMC Shadyside Hospital, McKeesport Hospital, and St. Margaret's Hospital who are unresponsive to standard antimicrobial therapy for CDAD.

During the course of this study we expect that IVIG group compared with placebo group will have fewer number of stools per day (\< 3 per day). Secondary endpoints will include normal WBC count, normal body temperature, 75% reduction in abdominal pain / tenderness, and decrease in length of hospital stay.

Subjects will sign a written informed consent prior to any study procedures. Patients will be monitored closely during the infusion of the study medication and will continue to be monitored on a daily basis up to the time of discharge. Data collection will include vital signs, CBC, stool C. difficile cytotoxin assay, and stool counts before and after therapy.

Detailed description:
See "Brief Summary" for details

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: intravenous immunoglobulin G (IVIG) intervention 2: Placebo
Intervention descriptions: intervention 1: IVIG to be given IV to patients with C-Diff . intervention 2: Placebo to be given IV to patients with C-Diff

Protocol document: