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Clinical Trials/EUCTR2008-004907-69-GB
EUCTR2008-004907-69-GB
Active, not recruiting
Not Applicable

A Phase II randomized, placebo-controlled, double-blind, dose ranging study of a Clostridium difficile toxoid vaccine (ACAM-CDIFF) in subjects with Clostridium difficile-associated infection(CDI) - N/A

Sanofi Pasteur Inc.0 sites612 target enrollmentOctober 3, 2008
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ConditionsRecurrence of Clostridium difficile Infection (CDI)MedDRA version: 12.0Level: LLTClassification code 10006834Term: C.difficile diarrheaMedDRA version: 12.0Level: LLTClassification code 10006835Term: C.difficile diarrhoeaMedDRA version: 12.0Level: LLTClassification code 10012734Term: Diarrhea, Clostridium difficileMedDRA version: 12.0Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileMedDRA version: 12.0Level: LLTClassification code 10022661Term: Intestinal infection due to clostridium difficileMedDRA version: 12.0Level: LLTClassification code 10054236Term: Clostridium difficile infection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Recurrence of Clostridium difficile Infection (CDI)
Sponsor
Sanofi Pasteur Inc.
Enrollment
612
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 3, 2008
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Adult subjects aged \=18 years.
  • •2\. Subjects who have been diagnosed with primary CDI within the last 12 days. Primary CDI is defined as a documented, laboratory\-confirmed CDI event that is either the first in the subject’s history or is occurring more than 90 days after a prior event.
  • •A CDI event is defined as follows:
  • •a change in bowel habit with passage of 3 or more loose stools within a 24 hour period (that conforms to the shape of the container it is placed into)
  • •a positive result is obtained via stool toxin test for C. difficile using either ELISA/EIA or PCR. The ELISA/EIA assay can be used to test for both toxin A and toxin B, while PCR can be used to test only for toxin B and for toxin regulator genes.
  • •absence of another identified cause for diarrhoea
  • •In addition, a stool cytotoxicity assay will be done in order to confirm the ELISA/EIA or PCR results. Vaccination may proceed before the results of this assay are known. However, if the results are available before a subject has received all 3 doses of ACAM\-CDIFF vaccine and are found to be negative, vaccination will be halted, and the subject will be followed only for safety (until 6 months after the last vaccination).
  • •A positive result for the stool cytotoxicity assay means that the sample is either positive for cytotoxin or has a toxin\-producing C. difficile by culture.
  • •3\. Subjects who are judged by the investigator to be medically stable and have a White Cell Count (WCC) \< 20,000 per µL and stable serum creatinine levels.
  • •4\. Subjects who understand the risks and benefits of participation, are willing and able to comply with the study procedures and visit schedules outlined, and who have provided written informed consent for the study.

Exclusion Criteria

  • •1\. Subjects who are currently on treatment for a CDI recurrence, or who have had a documented, laboratory\-confirmed CDI event, with or without treatment, within the past 90 days.
  • •2\. Subjects who are currently or have recently (within one month prior to enrolment in trial) been treated with immunoglobulin therapy.
  • •3\. Female subjects who are pregnant or breast feeding.
  • •4\. Subjects with WCC \> 20,000 per µL and acute rising serum creatinine levels (an acute increase of \>50% increase as assessed by investigator).
  • •5\. Concurrent, acutely life\-threatening diseases.
  • •6\. Predicted survival \< 91 days as determined by the investigator
  • •7\. Subjects with a platelet count of less than 70,000 cells/mm3 or other severe coagulation disorder that may increase risk of bleeding associated with vaccination.
  • •8\. Subjects who are significantly immunocompromised or immunodeficient due to medications (current or expected during study course) or disease, including:
  • •Subjects who are taking immunosuppressive therapy including systemic steroid therapy (e.g.; equivalent of prednisone \=10 mg daily for more than 14 days) or who are expected to need to take such medication during the course of the study.
  • •Subjects who are known to be HIV\+

Outcomes

Primary Outcomes

Not specified

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