Brief Summary
The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult participants undergoing hematopoietic stem cell transplantation (HSCT). The primary hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants undergoing HSCT.
Brief Title
Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)
Completion Date
Completion Date Type
Actual
Conditions
Clostridium Difficile-Associated Diarrhea (CDAD)
Eligibility Criteria
Inclusion Criteria:
* Male or female 18 years of age or older.
* Females of childbearing potential must be using an adequate and reliable method of contraception (e.g., abstinence, barrier with additional spermicide foam or jelly, intrauterine device, hormonal contraception). Males and females must agree to avoid conception during treatment and for four weeks following the end of study treatment.
* Is undergoing HSCT with planned Fluoroquinolone prophylaxis.
* Informed consent is provided.
Exclusion Criteria:
* Ongoing active CDAD infection (as evidenced by clinical signs of diarrhea along with the presence of either toxin A and/or B \[or their respective genes, tcdA and/or tcdB\] of C. difficile in the stool) or current treatment for CDAD.
* Undergoing cord blood transplants.
* Has fulminant colitis, toxic megacolon, or ileus.
* A history of inflammatory bowel disease (ulcerative colitis or Crohn's disease).
* Women who are pregnant or are actively breast feeding (all women of childbearing potential must have a negative pregnancy test result prior to dosing study drug).
* Use of any drugs potentially useful in the treatment of CDAD (e.g. oral Vancomycin, Metronidazole, oral Bacitracin, Fusidic Acid, Rifaximin, and Nitazoxanide).
* Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant in the study, would make it unlikely for the participant to complete the study, or would confound the results of the study.
* Participation in other clinical research studies utilizing an investigational agent within one month prior to screening and during the study treatment period.
* Male or female 18 years of age or older.
* Females of childbearing potential must be using an adequate and reliable method of contraception (e.g., abstinence, barrier with additional spermicide foam or jelly, intrauterine device, hormonal contraception). Males and females must agree to avoid conception during treatment and for four weeks following the end of study treatment.
* Is undergoing HSCT with planned Fluoroquinolone prophylaxis.
* Informed consent is provided.
Exclusion Criteria:
* Ongoing active CDAD infection (as evidenced by clinical signs of diarrhea along with the presence of either toxin A and/or B \[or their respective genes, tcdA and/or tcdB\] of C. difficile in the stool) or current treatment for CDAD.
* Undergoing cord blood transplants.
* Has fulminant colitis, toxic megacolon, or ileus.
* A history of inflammatory bowel disease (ulcerative colitis or Crohn's disease).
* Women who are pregnant or are actively breast feeding (all women of childbearing potential must have a negative pregnancy test result prior to dosing study drug).
* Use of any drugs potentially useful in the treatment of CDAD (e.g. oral Vancomycin, Metronidazole, oral Bacitracin, Fusidic Acid, Rifaximin, and Nitazoxanide).
* Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant in the study, would make it unlikely for the participant to complete the study, or would confound the results of the study.
* Participation in other clinical research studies utilizing an investigational agent within one month prior to screening and during the study treatment period.
Inclusion Criteria
Inclusion Criteria:
* Male or female 18 years of age or older.
* Females of childbearing potential must be using an adequate and reliable method of contraception (e.g., abstinence, barrier with additional spermicide foam or jelly, intrauterine device, hormonal contraception). Males and females must agree to avoid conception during treatment and for four weeks following the end of study treatment.
* Is undergoing HSCT with planned Fluoroquinolone prophylaxis.
* Informed consent is provided.
* Male or female 18 years of age or older.
* Females of childbearing potential must be using an adequate and reliable method of contraception (e.g., abstinence, barrier with additional spermicide foam or jelly, intrauterine device, hormonal contraception). Males and females must agree to avoid conception during treatment and for four weeks following the end of study treatment.
* Is undergoing HSCT with planned Fluoroquinolone prophylaxis.
* Informed consent is provided.
Gender
All
Gender Based
false
Keywords
Clostridium difficile
Clostridium difficile-Associated Diarrhea
Prophylaxis
Hematopoietic Stem Cell Transplantation
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01691248
Org Class
Industry
Org Full Name
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Org Study Id
5119-001
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
DEFLECT-1: A Phase 3b Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Demonstrate the Safety and Efficacy of Fidaxomicin for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation
Primary Outcomes
Outcome Description
CDAD is defined as follows: Diarrhea: (change in bowel habits with \>3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.
Outcome Measure
Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up.
Outcome Time Frame
Up to 30 days post-treatment
Secondary Ids
Secondary Id
OPT-80-302
Secondary Outcomes
Outcome Description
CDAD is defined as follows: Diarrhea: (change in bowel habits with \>3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.
Outcome Time Frame
Up to 60 days post-treatment
Outcome Measure
Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment.
Outcome Description
CDAD is defined as follows: Diarrhea: (change in bowel habits with \>3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.
Outcome Time Frame
Up to Day 70 of study
Outcome Measure
Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study.
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ramakrishna Battini
Investigator Email
rabattin@montefiore.org
Investigator Phone
718-920-4826
MeSH Terms
FIDAXOMICIN
OPT 80
COUNTERFEIT DRUGS
MACROLIDES
LACTONES
ORGANIC CHEMICALS
POLYKETIDES
MACROCYCLIC COMPOUNDS
POLYCYCLIC COMPOUNDS
SUBSTANDARD DRUGS
PHARMACEUTICAL PREPARATIONS