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

NCT03105479 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: AC-061A3032015-004805-17
• Study Type: interventional
• Target: 1
• Locations: 9 countries
• Sites: 20

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.

Conditions

Clostridium Difficile Infection

Keywords

vancomycin; children; cadazolid; clostridium difficile associated diarrhea

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  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.

  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.

  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.

  Day 10 (End of Treatment)

Secondary Outcomes (9)

• Clinical Cure Rate During Part A

  Day 10 (End of Treatment) + 2 days

• Sustained Clinical Cure Rate During Part A and Part B

  Day 40 (on average)

• Recurrence Rate During Part A and Part B

  Day 40 (on average)

• Time to Recurrence in Part B

  Day 40 (on average)

• Time to Resolution of Diarrhea in Part B

  Day 10

Study Arms (7)

Part A / Cohort A

EXPERIMENTAL

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.

Drug: Cadazolid

Part A / Cohort B

EXPERIMENTAL

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).

Drug: Cadazolid

Part A / Cohort C

EXPERIMENTAL

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.

Drug: Cadazolid

Part A/ Cohort D

EXPERIMENTAL

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.

Drug: Cadazolid

Part A/ Cohort E

EXPERIMENTAL

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.

Drug: Cadazolid

Part B / Cadazolid

EXPERIMENTAL

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.

Drug: Cadazolid

Part B / Vancomycin

ACTIVE COMPARATOR

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 .

Drug: Vancomycin capsule; Drug: Vancomycin solution

Interventions

Cadazolid DRUG

Granules for oral suspension to be administered twice daily

Also known as: ACT-179811

Part A / Cohort A; Part A / Cohort B; Part A / Cohort C; Part A/ Cohort D; Part A/ Cohort E; Part B / Cadazolid

Vancomycin capsule DRUG

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

Part B / Vancomycin

Vancomycin solution DRUG

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

Part B / Vancomycin

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actelion: lead

Study Sites (20)

Snake River Research, PLLC

Idaho Falls, Idaho, 83404, United States

Location

University of Chicago, Dept. Of Medicine

Chicago, Illinois, 60637, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71103, United States

Location

SUNY Upstate Medical University - Upstate Golisano Children's Hospital (GCH) - Pediatric Designated AIDS Center

Syracuse, Ohio, 13210, United States

Location

Texas Children's Hospital Feigin Cente

Houston, Texas, 77030, United States

Location

Universitair Ziekenhuis Brussel - Kinderziekenhuis

Jette, 1090, Belgium

Location

Infection Prevention & Control, AGW5 Foothills Medical Center 1403 29th Street N.W.

Calgary, T2N 2T9, Canada

Location

FN Brno

Brno, 62500, Czechia

Location

Egyesített Szent István és Szent László Kórház - Rendelőintézet / Gyermekinfektológiai Osztály

Budapest, 1097, Hungary

Location

Pándy Kálmán Megyei Kórház

Gyula, 5700, Hungary

Location

Ospedale Buzzi

Milan, 20154, Italy

Location

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

Roma, 00165, Italy

Location

Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza

Bydgoszcz, 85-030, Poland

Location

Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem

Poznan, 61-734, Poland

Location

Gabinet Lekarski Bartosz Korczowski

Rzeszów, 35-302, Poland

Location

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

Warsaw, 04-730, Poland

Location

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

Bucharest, 21105, Romania

Location

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

Iași, 700116, Romania

Location

Hospital Sant Joan de Déu, Esplugues

Barcelona, 8950, Spain

Location

Hospital Universitario Infantil LA PAZ

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

cadazolid; Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Only one subject was enrolled due to early study termination. Consequently results are not meaningful and no statistical analyses could be performed.

Results Point of Contact

• Title: clinical trial disclosure desk
• Organization: Actelion Pharmaceuticals Ltd

clinical-trials-disclosure@its.jnj.com

0041615656565

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor masking in Part B only (no masking in Part A)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 10, 2017
• Study Start: April 14, 2017
• Primary Completion: April 17, 2018
• Study Completion: April 17, 2018
• Last Updated: July 8, 2025
• Results First Posted: April 3, 2019

Record last verified: 2025-06

Locations

CA (1); HU (2); IT (2); PL (4); ES (2); US (5); BE (1); RO (2); CZ (1)