A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

Condition(s) targeted: Clostridium Difficile-associated Diarrhea (CDAD)

Intervention: Fidaxomicin (Drug); Vancomycin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Astellas Pharma Europe B.V.

Official(s) and/or principal investigator(s):
Clinical Research Physician, Study Director, Affiliation: Astellas Pharma Europe B.V.

Overall contact:
Global Clinical Science, Phone: +31 (0)71 5455 500, Email: Astellas.registration@astellas.com

The purpose of this study is to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD). It will also investigate the recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well as acceptance of the fidaxomicin oral suspension formulation.

Official title: A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Confirmed clinical response based on the assessment by the investigator

Secondary outcome:

Sustained clinical response at the end of study

Sustained clinical response 14 days after confirmation clinical response

Time to resolution of diarrhea

Recurrence of Clostridium difficile-associated Diarrhea (CDAD) during or at the end of the Follow-up period

Time to recurrence during or at the end of the Follow-up period

Minimum age: N/A. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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:

- Subject from Birth to < 2 years: watery diarrhea in the 24 hours prior to

screening.

- Subject ≥ 2 years to < 18 years: ≥ 3 unformed bowel movements in the 24 hours

prior to screening.

- For subjects < 5 years: Negative rotavirus test.

- Female subject of childbearing potential:

- must have a negative urine pregnancy test at Screening, and

- must abstain from sexual activity for the duration of the study, or

- 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.

- Female subject must not be breastfeeding at Screening or during the study period, and

for 28 days after the final study drug administration.

- Female subject must not donate ova starting at Screening and throughout the study

period, and for 28 days after the final study drug administration.

- Subject agrees not to participate in another interventional study while in the study

(with the exception of studies as described in exclusion criteria below). Exclusion Criteria:

- Concurrent use of metronidazole, oral vancomycin or any other antibiotic treatments

for CDAD. If the investigator feels the clinical imperative is 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.

- Subject has pseudomembranous colitis, fulminant colitis, toxic megacolon or ileus.

- Subject has a history of inflammatory bowel disease (e. g., ulcerative colitis or

Crohn's disease etc.).

- Subject has diarrhea caused by an agent other than C. difficile (e. g. infections,

infestations, drugs etc.).

- Subject has known hypersensitivity to fidaxomicin, vancomycin or their excipients or

to teicoplanin.

- 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.

Global Clinical Science, Phone: +31 (0)71 5455 500, Email: Astellas.registration@astellas.com

Site: 32001 Cliniques Universitaires Saint, Brussels 1200, Belgium; Recruiting

Site: 32003 Universitair Ziekenhuis Gent, Gent 9000, Belgium; Recruiting

32002: Centre Hospitalier Chretien, Liege 4020, Belgium; Recruiting

Site: 33002 CHU de Grenoble, La Tronche 38700, France; Recruiting

Site: 33003 CHU Arnaud de Villeneuve, Montpellier Cedex 5 34295, France; Recruiting

Site: 33001 Hopitaux pediatriques de Nice, Nice 6200, France; Recruiting

Site: 33007 Hôpital Archet 2, Nice 06200, France; Recruiting

33005: Hopital Trousseau, Paris 75012, France; Recruiting

Site: 33008 Hopital Hautepierre, Strasbourg Cedex 67098, France; Recruiting

Site: 49007 Charite-Universitatsmedizin Be, Berlin 13353, Germany; Recruiting

Site: 49002 Universitatsklinikum Frankfurt, Frankfurt 60596, Germany; Recruiting

Site: 49006 Universitätsklinikum Freiburg, Freiburg 79106, Germany; Recruiting

49004: Universitatsmedizin Mainz, Mainz 55131, Germany; Recruiting

Site: 49001 University Childrens Hos Muen, Muenster 48149, Germany; Recruiting

Site: 49003 Askleipios Klinik Sankt Aug Gmb, St. Augustin 53757, Germany; Recruiting

Site: 36001 Szent Janos Korhaz, Budapest 1023, Hungary; Recruiting

Site: 36003 SEMMELWEIS ORVOSTUDOMÁNYI EGYETEM (SOTE), Budapest 1094, Hungary; Recruiting

Site: 36006 Egyesitett Szent Istvan es Sze, Budapest 1097, Hungary; Recruiting

Site: 36004 Szegedi Tudomnyegyetem, Szeged 6720, Hungary; Recruiting

39002: Istituto Giannina Gaslini IRCC, Genova 16147, Italy; Recruiting

Site: 39004 Università degli Studi di Milano, Milano 20122, Italy; Recruiting

Site: 39001 Ospedale Pediatrico Bambino Gesù, Roma 00165, Italy; Recruiting

Site: 48007 Wojewodzki Szpital Obserwacyjn, Bydgoszcz 85-030, Poland; Recruiting

Site: 48004 Zaklad Opieki Zdrowotnej w Deb, Debica 39-200, Poland; Recruiting

48011: Uniwersyet Medyczny w Lodzi, Lodz 91-738, Poland; Recruiting

Site: 48006 Specjalistyczny Szital im.E.S, Tarnow 33-100, Poland; Recruiting

40003: Institul de Boli Infectioase, Bucharest, Romania; Recruiting

40004: Spitalul Clinic Urgenta Copii, Bucharest, Romania; Recruiting

Site: 40005 Spitalul Clinic, Bucharest, Romania; Recruiting

Site: 40002 Spitalul Clinic de Uregenta pen, Cluj 400217, Romania; Recruiting

Site: 40006 Emergency Clinical Hospital, Iasi, Romania; Recruiting

40001: Emergency Clinical Hospital, Timis 300011, Romania; Recruiting

Site: 42102 University Children Hospital, Banska Bystrica 974 01, Slovakia; Recruiting

Site: 42101 Univerzitna Nemocnica Martin U, Martin 036 59, Slovakia; Recruiting

Site: 34002 Hospital Sant Joan de Deu, Barcelona 8950, Spain; Recruiting

Site: 34004 Hospital Universitatio La Paz, Madrid 28046, Spain; Recruiting

Site: 34006 Hospital Clinico San Carlos, Madrid 28040, Spain; Recruiting

Site: 34003 H. U. Politecnico La Fe, Valencia 46026, Spain; Recruiting

Site: 10015 Children's Hospital of Orange City, Orange, California 92868, United States; Withdrawn

Site: 36007 Kenézy Gyula Kórház és Rendelőintézet, Debrecen, Hajdú-Bihar H-4031, Hungary; Recruiting

Site: 10010 University of Chicago, Chicago, Illinois 60637, United States; Recruiting

Site: 10004 Riley Hospital for Children, Indianapolis, Indiana 46202, United States; Recruiting

Site: 10025 University of Louisville, Louisville, Kentucky 40202, United States; Recruiting

Site: 10018 Tufts Medical Center, Boston, Massachusetts 02111, United States; Recruiting

Site: 48002 Instytut Pomnik - Centrum Zdro, Warszawa, Mazowieckie 04-730, Poland; Recruiting

Site: 10030 University of Nebraska Medical, Omaha, Nebraska 68114, United States; Recruiting

Site: 10012 North Shore LIJ Health System, Lake Success, New York 11042, United States; Recruiting

Site: 10008 The Research Foundation, Stony Brook, New York 11794-8111, United States; Recruiting

Site: 10027 Cincinnati Children's Hospital, Cincinnati, Ohio 45229-3039, United States; Recruiting

Site: 10003 University Hospital of Cleveland, Cleveland, Ohio 44106-5048, United States; Recruiting

Site: 10014 University of Toledo, Toledo, Ohio 43606, United States; Recruiting

Site: 15003 Lakeridge Health Corporation, Oshawa, Ontario L1G 2B9, Canada; Recruiting

Site: 15002 MUHC-Montreal Children's Hosp, Montreal, Quebec H3H 1P3, Canada; Recruiting

10034: Quillen College of Medicine, Johnson City, Tennessee 37604, United States; Recruiting

Site: 10022 St Jude Children's Res Hosp, Memphis, Tennessee 38105-2794, United States; Recruiting

Site: 10021 Medical College of Wisconsin, Milwaukee, Wisconsin 53214, United States; Recruiting

Starting date: October 2014
Last updated: July 27, 2015