Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)

NCT ID: NCT03105479

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-14
• Study Completion Date: 2018-04-17

Brief Summary

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.

Detailed Description

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.

Conditions

Clostridium Difficile Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Part A / Cohort A

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.

Group Type: EXPERIMENTAL

Cadazolid

Intervention Type: DRUG

Granules for oral suspension to be administered twice daily

Part A / Cohort B

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).

Group Type: EXPERIMENTAL

Cadazolid

Intervention Type: DRUG

Granules for oral suspension to be administered twice daily

Part A / Cohort C

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.

Group Type: EXPERIMENTAL

Cadazolid

Intervention Type: DRUG

Granules for oral suspension to be administered twice daily

Part A/ Cohort D

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.

Group Type: EXPERIMENTAL

Cadazolid

Intervention Type: DRUG

Granules for oral suspension to be administered twice daily

Part A/ Cohort E

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.

Group Type: EXPERIMENTAL

Cadazolid

Intervention Type: DRUG

Granules for oral suspension to be administered twice daily

Part B / Cadazolid

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.

Group Type: EXPERIMENTAL

Cadazolid

Intervention Type: DRUG

Granules for oral suspension to be administered twice daily

Part B / Vancomycin

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 .

Group Type: ACTIVE_COMPARATOR

Vancomycin capsule

Intervention Type: DRUG

Capsule containing 125 mg of vancomycin to be administered orally 4 times a day

Vancomycin solution

Intervention Type: DRUG

Vancomycin powder to be administered as oral solution at a dose of 40 mg/kg/day, 3 to 4 times a day

Interventions

Cadazolid

Granules for oral suspension to be administered twice daily

Intervention Type: DRUG

Vancomycin capsule

Capsule containing 125 mg of vancomycin to be administered orally 4 times a day

Intervention Type: DRUG

Vancomycin solution

Vancomycin powder to be administered as oral solution at a dose of 40 mg/kg/day, 3 to 4 times a day

Intervention Type: DRUG

Other Intervention Names

ACT-179811

Eligibility Criteria

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.

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Snake River Research, PLLC

Idaho Falls, Idaho, United States

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

Ospedale Buzzi

Milan, , Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Pediatrico Bambino Gesu

Roma, , Italy

Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza

Bydgoszcz, , Poland

Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem

Poznan, , Poland

Gabinet Lekarski Bartosz Korczowski

Rzeszów, , Poland

Klinika Gastroenterologii, Hepatologii, Zaburzeń Odżywiania i Pediatrii, Instytut "Pomnik - Centrum Zdrowia Dziecka"

Warsaw, , Poland

Institutul National De Boli Infectioase "Prof. Dr. Matei Bals", sectia IX pediatrie

Bucharest, , Romania

Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" Iasi, Clinica de Boli Infectioase I,

Iași, , Romania

Hospital Sant Joan de Déu, Esplugues

Barcelona, , Spain

Hospital Universitario Infantil LA PAZ

Madrid, , Spain

Countries

United States; Belgium; Canada; Czechia; Hungary; Italy; Poland; Romania; Spain

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2015-004805-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AC-061A303

Identifier Type: -

Identifier Source: org_study_id