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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03105479 |
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Date of registration:
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23/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)
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Scientific title:
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A Prospective, Multicenter Study to Investigate the Pharmacokinetics, Safety, and Efficacy of Cadazolid Versus Vancomycin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea |
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Date of first enrolment:
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April 14, 2017 |
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Target sample size:
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1 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03105479 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Belgium
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Canada
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Czech Republic
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Czechia
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Hungary
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Italy
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Poland
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Romania
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Spain
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Clostridium Difficile Infection
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Intervention(s)
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Drug: Cadazolid
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Drug: Vancomycin capsule
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Drug: Vancomycin solution
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Primary Outcome(s)
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Maximal Plasma Concentration (Cmax) of Cadazolid During Part A
[Time Frame: Day 10 (End of Treatment)]
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Area Under the Plasma Concentration Time Curve (AUC) of Cadazolid During Part A
[Time Frame: Day 10 (End of Treatment)]
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Time to Reach Cmax (Tmax) of Cadazolid During Part A
[Time Frame: Day 10 (End of Treatment)]
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Clinical Cure Rate During Part B
[Time Frame: Day 10 (End of Treatment) + 2 days]
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Fecal Concentrations of Cadazolid During Part A
[Time Frame: Day 10 (End of Treatment)]
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Secondary Outcome(s)
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Clinical Cure Rate During Part A
[Time Frame: Day 10 (End of Treatment) + 2 days]
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Sustained Clinical Cure Rate During Part A and Part B
[Time Frame: Day 40 (on average)]
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Marked Abnormalities in Clinical Laboratory Parameters
[Time Frame: Day 17 (on average)]
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Time to Recurrence in Part B
[Time Frame: Day 40 (on average)]
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Time to Resolution of Diarrhea in Part B
[Time Frame: Day 10]
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Treatment-emergent Adverse Events (TEAES)
[Time Frame: Day 17 (on average)]
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Marked Abnormalities in Vital Signs
[Time Frame: Day 17 (on average)]
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Recurrence Rate During Part A and Part B
[Time Frame: Day 40 (on average)]
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Adverse Events Leading to Premature Discontinuation of Study Treatment
[Time Frame: Up to Day 10]
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Secondary ID(s)
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2015-004805-17
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AC-061A303
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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