Trial Outcomes & Findings for IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff (NCT NCT00177970)
NCT ID: NCT00177970
Last Updated: 2016-10-25
Results Overview
During the course of the study, we expect the IVIG group compared to the placebo group will have a normal WBC count 3.8-10.0/CMM
TERMINATED
PHASE4
14 participants
during the course of the study
2016-10-25
Participant Flow
Enrollment number retrieved from old IRB database and not from study records and cannot be verified.
Participant milestones
| Measure |
IVIG
intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
|
Placebo
Placebo: Placebo to be given IV to patients with C-Diff
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: during the course of the studyPopulation: No results available record destroyed due to age of study. no publications
During the course of the study, we expect the IVIG group compared to the placebo group will have a normal WBC count 3.8-10.0/CMM
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: during the course of the studyPopulation: No results available record destroyed due to age of study. no publications
During the course of the study, we expect the IVIG group compared to the placebo group will have fewer number of stools per day (\<3 per day).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: during the course of the studyPopulation: No results available record destroyed due to age of study. no publications
During the course of the study, we expect the IVIG group compared to the placebo group will a 75% reduction in abdominal pain/tenderness
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: during the course of the studyPopulation: No results available record destroyed due to age of study. no publications
The quantity of anti-C. difficile antibodies with improve in relationship with recovery
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: during the course of the studyPopulation: No results available record destroyed due to age of study. no publications
A correlation will occur between antibody responses as measured with ELISA (enzyme immunoassay) and recovery of C. difficile diarrhea.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: during the course of the studyPopulation: No results available record destroyed due to age of study. no publications
During the course of the study, we expect the IVIG group compared to the placebo group will have normalization of neutrophil count (1.6-6.7)on CBC with diff.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: during the course of the studyPopulation: No results available record destroyed due to age of study. no publications
During the course of the study, we expect the IVIG group compared to the placebo group will have a normal body temperature of 98.6 F.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: during the course of the studyPopulation: No results available record destroyed due to age of study. no publications
During the course of the study, we expect the IVIG group compared to the placebo group will have a decrease in length of hospital stay.
Outcome measures
Outcome data not reported
Adverse Events
IVIG
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place