Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)
Clostridium Difficile Infection
About this trial
This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring vancomycin, children, cadazolid, clostridium difficile associated diarrhea
Eligibility Criteria
Key Inclusion Criteria:
- Signed informed consent by parents or legally authorized representatives (LAR) and assent by the child according to local requirements prior to initiation of any study-mandated procedure.
- Male or female from birth to < 18 years of age, diagnosed with Clostridium Difficile-associated diarrhea (CDAD).
- Females of childbearing potential must have a negative pregnancy test at screening and must agree to use an adequate and reliable method of contraception.
Key Exclusion Criteria:
- Positive Rotavirus test for subjects < 5 years.
- Fulminant or life-threatening CDAD.
- More than one previous episode of CDAD in the 3 month period prior to enrollment / randomization.
- Antimicrobial treatment active against CDAD administered within 24 h prior to screening except for metronidazole treatment failures (MTF).
- Subjects with body weight < 3 kg.
- Inflammatory bowel disease, chronic abdominal pain, or chronic diarrhea of any etiology.
- Fecal microbiota transplant (FMT), immunoglobulin therapy, or any investigational drug to prevent or treat CDAD within 1 month period (or 5 half-lives in case of investigational drug, whichever is longer) prior to enrollment / randomization.
- Monoclonal antibodies against C. difficile within 6 months prior to enrollment / randomization.
- Previous vaccination against C. difficile.
- Known mental disorders.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study, or compliance with the protocol.
Sites / Locations
- Snake River Research, PLLC
- University of Chicago, Dept. Of Medicine
- Louisiana State University Health Sciences Center - Shreveport
- SUNY Upstate Medical University - Upstate Golisano Children's Hospital (GCH) - Pediatric Designated AIDS Center
- Texas Children's Hospital Feigin Cente
- Universitair Ziekenhuis Brussel - Kinderziekenhuis
- Infection Prevention & Control, AGW5 Foothills Medical Center 1403 29th Street N.W.
- FN Brno
- Egyesített Szent István és Szent László Kórház - Rendelőintézet / Gyermekinfektológiai Osztály
- Pándy Kálmán Megyei Kórház
- Ospedale Buzzi
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Pediatrico Bambino Gesu
- Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza
- Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem
- Gabinet Lekarski Bartosz Korczowski
- Klinika Gastroenterologii, Hepatologii, Zaburzeń Odżywiania i Pediatrii, Instytut "Pomnik - Centrum Zdrowia Dziecka"
- Institutul National De Boli Infectioase "Prof. Dr. Matei Bals", sectia IX pediatrie
- Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" Iasi, Clinica de Boli Infectioase I,
- Hospital Sant Joan de Déu, Esplugues
- Hospital Universitario Infantil LA PAZ
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Part A / Cohort A
Part A / Cohort B
Part A / Cohort C
Part A/ Cohort D
Part A/ Cohort E
Part B / Cadazolid
Part B / Vancomycin
Subjects from 12 years to 18 years old (exclusive) will receive cadazolid 500 mg per day for 10 days. The dose may be adjusted based on the pharmacokinetic (PK) and safety data reviewed for the first 3 subjects.
Subjects from 6 years to 12 years old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort A reviewed by the Independent Data Monitoring Committee (IDMC).
Subjects from 2 years to 6 years old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort B reviewed by the IDMC.
Subjects from 3 months to 2 years old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort C reviewed by the IDMC.
Subjects from birth to 3 months old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort D reviewed by the IDMC.
Subjects from birth to 18 years old (exclusive) will receive cadazolid for 10 days, at the dose defined in the corresponding age cohort in Part A.
Subjects from birth to 18 years old (exclusive) will receive vancomycin capsule (for subjects able to swallow) or vancomycin solution (for the others) during 10 days .