EUCTR2015-004805-17-ES
Active, not recruiting
Phase 1
A prospective, multicenter study to investigate the pharmacokinetics, safety, and efficacy of cadazolid versus vancomycin in pediatric subjects with Clostridium difficile-associated diarrhea.
ConditionsClostridium difficile-associated diarrhea (CDAD)MedDRA version: 20.0Level: LLTClassification code 10012734Term: Diarrhea, Clostridium difficileSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: PTClassification code 10054236Term: Clostridium difficile infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: LLTClassification code 10022661Term: Intestinal infection due to clostridium difficileSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Clostridium difficile-associated diarrhea (CDAD)
- Sponsor
- Actelion Pharmaceuticals Ltd.
- Enrollment
- 1
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Parts A and B:
- •\- 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.
- •\- Subject is diagnosed with CDAD
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 200
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Parts A and B:
- •\- 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 enrolment/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 enrolment/randomization.
- •\- Monoclonal antibodies against C. difficile within 6 months prior to enrolment/randomization.
- •\- Previous vaccination against C. difficile.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A clinical study to compare the effects of cadazolid with vancomycin in children with Clostridium difficile-associated diarrhea.EUCTR2015-004805-17-BEActelion Pharmaceuticals Ltd.200
Active, not recruiting
Phase 1
A clinical study to compare the effects of cadazolid with vancomycin in children with Clostridium difficile-associated diarrhea.EUCTR2015-004805-17-ITActelion Pharmaceuticals Ltd.200
Active, not recruiting
Phase 1
A clinical study to compare the effects of cadazolid with vancomycin in children with Clostridium difficile-associated diarrhea.EUCTR2015-004805-17-HUActelion Pharmaceuticals Ltd.200
Completed
Not Applicable
Pulmonary Hypertension in the Intensive Care Unit (ICU) - Swiss Survey 1ISRCTN01751283Swiss Society of Pulmonary Hypertension (Switzerland)1,000
Completed
Not Applicable
A Prospective Study, Multi-center Investigation of Impact of the Reinforced Staple Technology during Anastomosis of Laparoscopic Rectal SurgeryColon cancerJPRN-UMIN000029543Sapporo Medical University307