Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00350298
Other study ID # CA-GCDX-06-02
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 20, 2006
Est. completion date June 25, 2008

Study information

Verified date January 2021
Source MassBiologics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with Clostridium difficile associated disease who fulfill the eligibility criteria will be approached to participate. All study patients must receive standard of care treatment for Clostridium difficile associated disease. Enrolled patients will be randomized to receive a single intravenous solution of a human monoclonal antibody (huMab) to C. difficile toxin A (GS-CDA1) combined with a human monoclonal antibody to C. difficile toxin B (MDX-1388) or 0.9% sodium chloride as placebo in a 1:1 treatment allocation. Patients will be evaluated for safety and clinical outcomes through day 84 +/- 10 days. Occurrence of adverse events, use of concomitant medications, and stool output will be assessed at scheduled phone contacts and study visits. Some patients enrolled will have a subsequent visit on day 168 ± 14 days.


Description:

This study is a phase II, randomized, double-blind, placebo-controlled study in patients diagnosed with Clostridium difficile associated disease. Patients with Clostridium difficile associated disease will be identified either from stool test results or by physician referral, and those who fulfill the eligibility criteria will be approached to participate. All study patients must receive standard of care treatment for Clostridium difficile associated disease. Enrolled patients will be randomized to receive a single intravenous solution of a human monoclonal antibody to C. difficile toxin A (GS-CDA1) combined with a human monoclonal antibody to C. difficile toxin B (MDX-1388) or 0.9% sodium chloride as placebo in a 1:1 treatment allocation. One hundred patients will be enrolled in the combination monoclonal antibody treated arm and 100 patients will be enrolled in the placebo arm. Patients will be evaluated through day 84 ± 10 days after receipt of study infusion for safety and clinical outcomes. Blood samples for safety analyses, anti-toxin A and anti-toxin B antibody measurements and human anti-human antibody (HAHA) titers will be collected at scheduled times. Study visits will occur on days 3 ± 1, 10 ± 2, 28 ± 3, 56 ± 7 and on day 84 ± 10 days. Occurrence of adverse events, use of concomitant medications, and record of stool output will be assessed at scheduled phone contacts and study visits. The first 20 patients enrolled will have a subsequent visit on day 168 ± 14 days for an additional blood collection for HAHA analysis.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date June 25, 2008
Est. primary completion date June 25, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patient > 18 years of age with diarrhea associated with a positive stool test for C. difficile toxin(s). Patients may be diagnosed with C. difficile by hospital/clinic/reference microbiology laboratory test or by a rapid diagnostic test performed by the study staff and positive test result must be within 14 days of enrollment. 2. Patient must receive standard of care treatment for C. difficile associated disease. Standard of care treatment should include either metronidazole by mouth or intravenously or vancomycin by mouth. 3. Patient or legal representative must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained. Exclusion Criteria: 1. History of chronic diarrheal illness such as ulcerative colitis or Crohn's disease. 2. Score of 4 on modified Horn's index 3. Severe C. difficile colitis with planned surgery in less than 24 hours. 4. Positive pregnancy test within 24 hours of study infusion or an unwillingness to undergo pregnancy testing in females of child-bearing potential. Females capable of child-bearing must agree not to become pregnant from the time of study enrollment until at least 3 months after completion of study infusion. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to use hormonal or barrier birth control with spermicidal gel. 5. Breastfeeding. 6. Receipt of other investigational study agent within previous 30 days. 7. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the patient participating in the study or make it unlikely the patient could complete the study.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
GS-CDA1/MDX-1388
One Intravenous dose
normal saline
One Intravenous dose

Locations

Country Name City State
Canada University of Calgary Foothills Medical Center Calgary Alberta
Canada Centre de Sante et Services Sociaux de Chicoutimi Chicoutimi Quebec
Canada Kingston General Hospital Kingston Ontario
Canada Centre Hospitalier Regional de Trois-Rivieres Trois-Rivieres Quebec
Canada Vancouver Island Health Research Centre Victoria British Columbia
Canada Windsor Regional Hospital WIndsor Ontario
Canada Health Sciences Centre, University of Manitoba Winnepeg Manitoba
United States Summa Health System Akron Ohio
United States Central Indiana Gastroenterology Group Anderson Indiana
United States Saint James Healthcare Butte Montana
United States Remington-Davis Clinical Research Columbus Ohio
United States Chest, Infectious Diseases and Critical Care Assoc., PC Des Moines Iowa
United States St. Lukes Episcopal Hospital Houston Texas
United States Idaho Falls Infectious Diseases, PLLC Idaho Falls Idaho
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States University of Kentucky Medical Center Lexington Kentucky
United States LAC/USC Medical Center Los Angeles California
United States UCLA CURE Digestive Diseases Center Los Angeles California
United States Jersey Shore University Medical Center Neptune New Jersey
United States Mount Sinai Hospital New York New York
United States Christiana Care Health Systems Newark Delaware
United States Kaiser Permanente Vaccine Study Center Oakland California
United States Rapid City Regional Hospital Rapid City South Dakota
United States Mayo Clinic Rochester Minnesota
United States MultiCare Health System Research Services Tacoma Washington
United States Dr. Kiran C. Patel Research Institute Tampa Florida
United States Scott and White Memorial Hospital Temple Texas
United States Henry Ford Health System West Bloomfield Michigan
United States All-Trials Clinical Research, LLC Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
MassBiologics Medarex

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Recurrence of Clostridium Difficile Associated Disease (CDAD) Determine if the addition of C. difficile toxin A and toxin B human monoclonal anti-toxin antibodies to standard of care treatment reduces the number of subjects with recurrent CDAD compared to standard of care and placebo. Standard of care treatment is defined as receipt of either metronidazole by mouth or parenterally or receipt of vancomycin by mouth with a standard duration of treatment defined as 10 - 14 days (+ 2 days)). Recurrence of CDAD is defined as the development of a new episode of C. difficile disease associated with a positive C. difficile stool toxin(s) test after the resolution of prior episode and after discontinuation of SOC treatment. Day 0 to Day 84
Secondary Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported Safety and tolerability of a C. difficile toxin A human monoclonal antibody combined with a human monoclonal antibody to C. difficile toxin B in patients receiving standard of care treatment for C. difficile associated disease (CDAD) compared to those patients receiving standard of care and placebo reporting system organ class (SOC) MedDRA V.9.0 Day 0 to Day 84
Secondary Time to Resolution of Initial CDAD Episode Determine if the addition of a C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody to standard of care treatment reduces the time to resolution of diarrhea in patients with CDAD compared to those patients receiving standard of care and placebo. Resolution of CDAD is defined as the cessation of diarrhea for at least two consecutive days. Day 0 to Day 84
Secondary Number of Patients With Standard of Care Treatment Failure Determine if the addition of a C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody to standard of care treatment reduces the number of patients who experience standard of care treatment failure compared to those patients receiving standard of care and placebo. Standard of care treatment failure is defined as (i) recurrence of diarrhea (after it had initially resolved) while on SOC treatment during the first 14 days, or (ii) change in SOC treatment (i.e., antibiotics given), or (iii) diarrhea episode lasting =14 days while on SOC treatment. Day 0 to Day 84
Secondary Number of Patients With Severe Initial C. Difficile Disease Determine if the addition of a C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody to standard of care treatment reduces the number of patients with severe C. difficile disease compared to those patients receiving standard of care and placebo. Severe initial disease is defined as = 5 unformed stools/day for 2 consecutive days from day 1 to the end of the initial episode of diarrhea and discontinuation of SOC. Day 0 to Day 84
Secondary Antibody Concentrations to Toxin A and to Toxin B Between Treatment Groups Antibody concentrations to Toxin A and to Toxin B in those patients receiving C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody and standard of care treatment to those patients receiving standard of care and placebo Day 0 to Day 84
See also
  Status Clinical Trial Phase
Recruiting NCT04179201 - Study on Clostridium Difficile Infection in Chinese Patients With Inflammatory Bowel Disease
Completed NCT02563106 - A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI Phase 2
Completed NCT00214461 - Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers Phase 1
Completed NCT00314951 - Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) Phase 3
Completed NCT00328263 - Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients Phase 3
Completed NCT00127803 - Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers Phase 1
Withdrawn NCT05077085 - Bezlotoxumab Versus FMT for Multiple Recurrent CDI Phase 4
Recruiting NCT02681068 - MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation N/A
Completed NCT00446355 - Clinical Outcomes of Patients With Clostridium Difficile Associated Disease Attributable to Diverse tcdC Genotypes N/A
Terminated NCT00384527 - Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease Phase 3
Completed NCT00269399 - A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) Phase 3
Completed NCT04026009 - Safety and Immunogenicity Study of GSK's Clostridium Difficile Vaccine 2904545A When Administered in Healthy Adults Aged 18-45 Years and 50-70 Years Phase 1
Recruiting NCT06277999 - C.Difficile Observational Study
Completed NCT00468728 - PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) Phase 3