Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. This is the first study of cadazolid in children. The overall purpose of this study is to provide reassurance on the safety and efficacy of cadazolid in children suffering from infection due to Clostridium difficile.
This multicenter, study will be run into two parts. Both parts will be run in consecutive age cohorts, starting from the oldest age categories(12 to \< 18 years old) to the youngest (birth to \< 3 months). * Part A is an open-label, dose finding part to be conducted in at least 24 subjects. * Part B follows a randomized, assessor-blinded, parallel-group design with vancomycin used as an active comparator. Part B will be conducted in about 176 children. In both parts, the treatment period will be 10 days and will be followed by a Follow-up period of 28-32 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1
Granules for oral suspension to be administered twice daily
Capsule containing 125 mg of vancomycin to be administered orally 4 times a day
Vancomycin powder to be administered as oral solution at a dose of 40 mg/kg/day, 3 to 4 times a day
Snake River Research, PLLC
Idaho Falls, Idaho, United States
Clinical Cure Rate During Part B
This is the percentage of participants in part B reported as with a clinical cure. Clinical Cure is defined as: • \<3 unformed bowel movement (UBM) per day (or no water diarrhea if subjects \< 2 years of age), for at least 2 consecutive days between first dose of study treatment up to end of treatment (EOT) (inclusive) AND • Subject remains well up to EOT + 2 days (inclusive) based on investigator judgment AND • No need for additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) between first dose of study treatment up to EOT + 2 days (inclusive). percentage of subjects with a clinical cure
Time frame: Day 10 (End of Treatment) + 2 days
Maximal Plasma Concentration (Cmax) of Cadazolid During Part A
Blood samples are collected at different timepoints on Day 10 for the determination of cadazolid Cmax after 10 days of treatment.
Time frame: Day 10 (End of Treatment)
Time to Reach Cmax (Tmax) of Cadazolid During Part A
Blood samples are collected at different timepoints to determine the time when the maximal plasma concentration of cadazolid is reached.
Time frame: Day 10 (End of Treatment)
Area Under the Plasma Concentration Time Curve (AUC) of Cadazolid During Part A
Blood samples are collected at different timepoints for the determination of the cadazolid AUC over one dosing interval (0-12h) on Day 10.
Time frame: Day 10 (End of Treatment)
Fecal Concentrations of Cadazolid During Part A
A fecal sample is collected as the end-of-treatment visit in all participants in Part A.
Time frame: Day 10 (End of Treatment)
Clinical Cure Rate During Part A
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Chicago, Dept. Of Medicine
Chicago, Illinois, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
SUNY Upstate Medical University - Upstate Golisano Children's Hospital (GCH) - Pediatric Designated AIDS Center
Syracuse, Ohio, United States
Texas Children's Hospital Feigin Cente
Houston, Texas, United States
Universitair Ziekenhuis Brussel - Kinderziekenhuis
Jette, Belgium
Infection Prevention & Control, AGW5 Foothills Medical Center 1403 29th Street N.W.
Calgary, Canada
FN Brno
Brno, Czechia
Egyesített Szent István és Szent László Kórház - Rendelőintézet / Gyermekinfektológiai Osztály
Budapest, Hungary
Pándy Kálmán Megyei Kórház
Gyula, Hungary
...and 10 more locations
This is the percentage of participants in Part A reported as with a clinical cure. Clinical Cure is defined as: • \<3 unformed bowel movement (UBM) per day (or no water diarrhea if subjects \< 2 years of age), for at least 2 consecutive days between first dose of study treatment up to end of treatment (EOT) (inclusive) AND • Subject remains well up to EOT + 2 days (inclusive) based on investigator judgment AND • No need for additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) between first dose of study treatment up to EOT + 2 days (inclusive).
Time frame: Day 10 (End of Treatment) + 2 days
Sustained Clinical Cure Rate During Part A and Part B
This is the percentage of participants in Parts A and B reported as with sustained clinical cure. Sustained clinical cure is defined as • Clinical Cure and no Recurrence until 30 days after the last study drug intake (end of study).
Time frame: Day 40 (on average)
Recurrence Rate During Part A and Part B
This is the percentage of participants in Parts A and B assessed as having a recurrence out of subjects meeting the criteria for Clinical Cure. Recurrence is defined as: • Clinical Cure AND New episode of diarrhea with ≥ 3 UBMs (or watery diarrhea if subject \< 2 years) on any day between EOT + 3 days and end of study AND • Stool test showing positive C. difficile (as defined in Inclusion Criterion 4), AND •Antimicrobial treatment active against CDAD started between EOT + 3 days and end of study.
Time frame: Day 40 (on average)
Time to Recurrence in Part B
This it the time (in days) elapsed between the last dose of study drug and the onset day of new episode of diarrhea reported as Kaplan-Meier estimates (KM estimates)
Time frame: Day 40 (on average)
Time to Resolution of Diarrhea in Part B
This is the time (in days) elapsed between the first dose of study treatment and the resolution of diarrhea and reported as Kaplan-Meier estimates (KM estimates). The date of resolution of Diarrhea (ROD) is defined as the date of the first day of the 2 consecutive days on treatment with \< 3 UBM (or no watery diarrhea for subjects \< 2 years of age). Time to ROD is the time (in days) elapsed between the first dose of study treatment and the ROD
Time frame: Day 10
Adverse Events Leading to Premature Discontinuation of Study Treatment
Number of participants who prematurely discontinued the study treatment due to an adverse event
Time frame: Up to Day 10
Marked Abnormalities in Clinical Laboratory Parameters
Number of participants with any marked abnormalities in laboratory parameters up to 7 days after end of treatment
Time frame: Day 17 (on average)
Marked Abnormalities in Vital Signs
Number of subjects with any treatment-emergent abnormalities in vital signs (up to 7 days after end of treatment)
Time frame: Day 17 (on average)
Treatment-emergent Adverse Events (TEAES)
Number of subjects with any TEAEs. A TEAE is any adverse event temporally associated with the use of study treatment (from study treatment initiation until 7 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.
Time frame: Day 17 (on average)