Efficacy and Safety of Fidaxomicin and Vancomycin

Principal Investigator: Molly  O'Gorman
Keywords: Fidaxomicin , Vancomycin , Clostridium , Diarrhea Department: Pediatric Administration
IRB Number: 00081705 Co Investigator:  
Specialty: Pediatric Gastroenterology
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Amy Holman
amy.holman@hsc.utah.edu
801-587-7484

Brief Summary


Study Objectives


Primary
The primary objective of this study is to investigate the clinical response to fidaxomicin oral
suspension or tablets and vancomycin oral liquid or capsules of pediatric subjects with Clostridium
difficile-associated diarrhea (CDAD) aged ≥ 6 months to < 18 years.

Secondary
The secondary objectives of this study are to investigate the recurrence/sustained clinical
response to and safety of fidaxomicin and vancomycin in pediatric subjects with Clostridium
difficile-associated diarrhea (CDAD) aged ≥ 6 months to < 18 years, as well as acceptance of
the fidaxomicin oral suspension formulation.

Inclusion Criteria


Inclusion Criteria


Subject is eligible for the study if all of the following apply:
1.  Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed
Consent/assent (if applicable) and privacy language as per national regulations (e.g., HIPAA
Authorization for US sites) must be obtained from the subject or legally authorized representative
prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
2.  Male and female subjects aged ≥ 6 months to < 18 years.
3.   Subject is diagnosed with CDAD according to local diagnostic criteria. As a minimum there must
be positive detection, within 72 hours prior to randomization, of either toxin A and/or toxin B in stool or positive detection of toxigenic C. difficile in stool and:
a.   Subject ≥ 6 months to < 2 years: watery diarrhea in the 24 hours prior to screening.
b.  Subject ≥ 2 years to < 18 years: > 3 unformed bowel movements in the 24 hours prior to screening.
4.  For subjects < 5 years: Negative rotavirus test.
5.  Female subject of childbearing potential:
a.  must have a negative urine pregnancy test at Screening, and
b.  must abstain from sexual activity for the duration of the study, or
c.   must use two forms of birth control* (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days after the final study drug administration.
6.  Female subject must not be breastfeeding at Screening or during the study period, and for 28
days after the final study drug administration.
7.  Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
8.  Subject agrees not to participate in another interventional study while in the study (with the exception of studies as described in exclusion criteria 6).


*Acceptable forms of birth control include:
▪ Established use of oral, injected or implanted hormonal methods of contraception.
▪ Placement of an intrauterine device (IUD) or intrauterine system (IUS).
▪ Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with
spermicidal foam/gel/film/cream/suppository.
 

Exclusion Criteria


Exclusion Criteria
Subject will be excluded from participation if any of the following apply:
1.  Concurrent use of metronidazole, oral vancomycin or any other antibiotic treatments for CDAD.
If the investigator feels the clinical imperative to begin treatment before knowing the laboratory
result for toxigenic C.difficile, up to four doses but no more than 24 hours of treatment with
metronidazole, oral vancomycin or any other effective treatment for CDAD are allowed.
2.  Subject has pseudomembranous colitis, fulminant colitis, toxic megacolon or ileus.
3.  Subject has a history of inflammatory bowel disease (e.g., ulcerative colitis or Crohn’s disease etc.).
4.  Subject has diarrhea caused by an agent other than C. difficile (e.g., infections, infestations, drugs etc.).
5.  Subject has known hypersensitivity to fidaxomicin, vancomycin or their excipients or to teicoplanin.
6.  Subject has received an investigational therapy within 28 days, prior to Screening, with the
exception of studies with primary treatment for cancer without novel Investigational Medicinal Product (IMP) and which do not affect the assessment of diarrhea.
7.  Subject has a condition which, in the investigator’s opinion, makes the subject unsuitable for study participation.


Waivers to the exclusion criteria will NOT be allowed.