Clostridium Difficile-associated Diarrhea (CDAD)Phase 4NCT00177970
IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff
A Phase 4 study testing intravenous immunoglobulin G (IVIG) in people with Clostridium Difficile-associated Diarrhea (CDAD), run by University of Pittsburgh at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile-associated Diarrhea (CDAD)
- What is being tested?
- intravenous immunoglobulin G (IVIG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2003to Apr 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and female greater than 18 years of age
- Positive stool C. difficile cytotoxin assay and/or biopsy evidence of Pseudomembranous Colitis (PMC) at onset of illness
- Current history of severe, relapsing CDAD or Current history of severe, refractory CDAD
- A score of 6 or 7 on the C.Diff Severity and Prognosis Score (CDSPS) scale27,28,29,30 OR failure to respond (as identified by a score of 4 or more on the CDSPS scale below) to any of the following: a 4-day or more course of oral or IV metronidazole 500 mg po TID or QID; or to a 4-day course of oral vancomycin 125-500 mg po Q6 hours; or to a 4-day course of vancomycin enemas; or failure to respond to a 4-day course of combination therapy of oral vancomycin 125-500 mg po Q6 hours and IV metronidazole 500mg IV Q8 or Q6 hours and/or vancomycin enemas.
- CDSPS SCALE (each item is scored as one point for a 7 point maximum total)
- underlying immunosuppression/chronic medical condition
Show all 12Show fewer
- altered or depressed mental status as defined by medical chart documentation
- abdominal pain and/or distention
- WBC > 20,000 or < 1,500 and/or bandemia > 10%
- hypoalbuminemia (<3 mg/dL)
- ascites (clinically or per CT scan findings per medical chart)
- abnormal CT scan findings per medical chart -
Who cannot join
- Pregnant or lactating women
- Selective IgA deficiency
- Hypersensitivity to immune globulin, human albumin, or thimerosal -
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UPMC McKeesport Hospital and SemperCare Hospital of McKeesport, Inc
Pittsburgh, Pennsylvania, 15132
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
UPMC St. Margaret Hospital
Pittsburgh, Pennsylvania, 15215
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Intravenous Immunoglobulin G Versus Placebo for the Treatment of Patients With Severe Clostridium Difficile-Associated Diarrhea and Colitis
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.
Read the detailed description
See "Brief Summary" for details
- Being tested
- intravenous immunoglobulin G (IVIG), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous immunoglobulin G (IVIG)Drug
Also called IVIG
IVIG to be given IV to patients with C-Diff .
PlaceboDrug
Placebo to be given IV to patients with C-Diff
| Study group | Role | What they receive |
|---|---|---|
| IVIG | Active comparator | Not described Receives: Drug: intravenous immunoglobulin G (IVIG) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) Normalization of WBC's
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
Measured: during the course of the study
2) Decrease of Number of Loose Stools to <3 Per Day Following Treatment
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).
Measured: during the course of the study
Secondary outcomes (6)
1) 75% Reduction in Abdominal Pain/Tenderness
During the course of the study, we expect the IVIG group compared to the placebo group will a 75% reduction in abdominal pain/tenderness
Measured: during the course of the study
2) Quantity of Anti-C. Difficile Antibodies in Relationship With Recovery of C. Difficile Diarrhea
The quantity of anti-C. difficile antibodies with improve in relationship with recovery
Measured: during the course of the study
3) Correlation Between Antibody Responses as Measured With ELISA (Enzyme Immunoassay) and Recovery of C. Difficile Diarrhea
A correlation will occur between antibody responses as measured with ELISA (enzyme immunoassay) and recovery of C. difficile diarrhea.
Measured: during the course of the study
4) Normalization of Neutrophil Count on CBC With Diff.
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.
Measured: during the course of the study
5) Normalization of Body Temperature During a 24 Hour Period
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.
Measured: during the course of the study
6) Patients' Length of Hospital Stay
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.
Measured: during the course of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: We were unable to receive IVIG free from phamaceutical company.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clostridium Difficile-associated Diarrhea (CDAD)Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Shadyside Hospital Foundation, Bayer
- Responsible party
- Sponsor
- Investigators
- George L Arnold, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177970
- Sponsor's protocol ID
- 0311034
- Status last verified
- Sep 2016
- First submitted
- 13 Sep 2005
- Last updated
- 25 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: records not available
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Immunoglobulin G Versus Placebo for the Treatment of Patients With Severe Clostridium Difficile-Associated Diarrhea and Colitis
- ClinicalTrials.gov ID
- NCT00177970
- Acronym / sponsor ID
- 0311034
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We were unable to receive IVIG free from phamaceutical company.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Shadyside Hospital Foundation, Bayer
- Study start
- Oct 2003
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 15 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVIG | Active comparator | Drug: intravenous immunoglobulin G (IVIG) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males and female greater than 18 years of age
- Positive stool C. difficile cytotoxin assay and/or biopsy evidence of Pseudomembranous Colitis (PMC) at onset of illness
- Current history of severe, relapsing CDAD or Current history of severe, refractory CDAD
- A score of 6 or 7 on the C.Diff Severity and Prognosis Score (CDSPS) scale27,28,29,30 OR failure to respond (as identified by a score of 4 or more on the CDSPS scale below) to any of the following: a 4-day or more course of oral or IV metronidazole 500 mg po TID or QID; or to a 4-day course of oral vancomycin 125-500 mg po Q6 hours; or to a 4-day course of vancomycin enemas; or failure to respond to a 4-day course of combination therapy of oral vancomycin 125-500 mg po Q6 hours and IV metronidazole 500mg IV Q8 or Q6 hours and/or vancomycin enemas.
- CDSPS SCALE (each item is scored as one point for a 7 point maximum total)
Key exclusion criteria (3 listed)
- Pregnant or lactating women
- Selective IgA deficiency
- Hypersensitivity to immune globulin, human albumin, or thimerosal -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous immunoglobulin G (IVIG)Also: IVIGIVIG to be given IV to patients with C-Diff . | Drug | IVIG |
| PlaceboPlacebo to be given IV to patients with C-Diff | Drug | Placebo |
Primary outcome
1) Normalization of WBC's
Time frame: during the course of the study
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
2) Decrease of Number of Loose Stools to <3 Per Day Following Treatment
Time frame: during the course of the study
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).
6 secondary outcomes
1) 75% Reduction in Abdominal Pain/Tenderness
Time frame: during the course of the study
2) Quantity of Anti-C. Difficile Antibodies in Relationship With Recovery of C. Difficile Diarrhea
Time frame: during the course of the study
3) Correlation Between Antibody Responses as Measured With ELISA (Enzyme Immunoassay) and Recovery of C. Difficile Diarrhea
Time frame: during the course of the study
4) Normalization of Neutrophil Count on CBC With Diff.
Time frame: during the course of the study
5) Normalization of Body Temperature During a 24 Hour Period
Time frame: during the course of the study
6) Patients' Length of Hospital Stay
Time frame: during the course of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. records not available
Related trials for Clostridium Difficile-associated Diarrhea (CDAD)
Recruiting
Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea
Clostridium; Difficile, As Cause of Disease Classified Elsewhere, Clostridium Difficile Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George L Arnold, MD principal investigator
University of Pittsburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravenous immunoglobulin G (IVIG) in people with Clostridium Difficile-associated Diarrhea (CDAD), run by University of Pittsburgh at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1) Normalization of WBC's (time frame: during the course of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.