Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| OPT-80-206 | Other Identifier | Optimerpharma Study Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fidaxomicin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fidaxomicin | Drug | 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days. 6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events. | Number of participants with adverse events, as categorized by MedDRA. | Enrollment through end of study (Day 38-41) |
| Investigate Concentrations of Fidaxomicin in Plasma Samples. | 3-5 hour plasma levels of fidaxomicin (mean) | 3-5 hours after administration |
| Investigate Concentrations of Fidaxomicin in Fecal Samples. | End of therapy fecal levels of fidaxomicin (mean) | End of Therapy; Day 10-11 |
| Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples. | 3-5 hour plasma levels of OP-1118 (mean) | 3-5 hours after administration |
| Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples. | End of therapy fecal levels of OP-1118 (mean) | End of Therapy; Day 10-11 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Clinical Outcome by Assessment of Clinical Response. | Positive clinical response defined as resolution of diarrhea | Day 10 |
| Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28575523 | Result | O'Gorman MA, Michaels MG, Kaplan SL, Otley A, Kociolek LK, Hoffenberg EJ, Kim KS, Nachman S, Pfefferkorn MD, Sentongo T, Sullivan JE, Sears P. Safety and Pharmacokinetic Study of Fidaxomicin in Children With Clostridium difficile-Associated Diarrhea: A Phase 2a Multicenter Clinical Trial. J Pediatric Infect Dis Soc. 2018 Aug 17;7(3):210-218. doi: 10.1093/jpids/pix037. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Fidaxomicin | fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days. 6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Positive clinical response without recurrence through the follow-up period
| 28 days post-treatment |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fidaxomicin | fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days. 6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events. | Number of participants with adverse events, as categorized by MedDRA. | Subjects receiving any amount of study drug | Posted | Number | participants | Enrollment through end of study (Day 38-41) |
|
|
| ||||||||||||||||||||||||||
| Primary | Investigate Concentrations of Fidaxomicin in Plasma Samples. | 3-5 hour plasma levels of fidaxomicin (mean) | Treated subjects with evaluable plasma pharmacokinetic data | Posted | Mean | Standard Deviation | ng/mL | 3-5 hours after administration |
|
| ||||||||||||||||||||||||||
| Primary | Investigate Concentrations of Fidaxomicin in Fecal Samples. | End of therapy fecal levels of fidaxomicin (mean) | Treated subjects with evaluable fecal data | Posted | Mean | Standard Deviation | microgram/g | End of Therapy; Day 10-11 |
|
| ||||||||||||||||||||||||||
| Secondary | Evaluate the Clinical Outcome by Assessment of Clinical Response. | Positive clinical response defined as resolution of diarrhea | Treated subjects with positive toxin assay result within 24 hours of enrollment | Posted | Number | 95% Confidence Interval | percentage of subjects | Day 10 |
|
| ||||||||||||||||||||||||||
| Secondary | Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response. | Positive clinical response without recurrence through the follow-up period | Treated subjects with positive toxin assay result within 24 hours of enrollment | Posted | Number | 95% Confidence Interval | percentage of participants | 28 days post-treatment |
|
| ||||||||||||||||||||||||||
| Primary | Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples. | 3-5 hour plasma levels of OP-1118 (mean) | Treated subjects with evaluable plasma pharmacokinetic data | Posted | Mean | Standard Deviation | ng/mL | 3-5 hours after administration |
|
| ||||||||||||||||||||||||||
| Primary | Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples. | End of therapy fecal levels of OP-1118 (mean) | Treated subjects with evaluable fecal data | Posted | Mean | Standard Deviation | microgram/g | End of Therapy; Day 10-11 |
|
|
From informed consent through 30 days after the last administration of study treatment.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fidaxomicin | fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days. 6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days. | 9 | 38 | 17 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clostridium difficilie colitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hematemesis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| adenovirus infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| clostridial infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| septic shock | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| gastrostomy failure | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| oesophagitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| chest pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
Publication or other public presentation of results from this study requires prior review and written approval of the Sponsor. Draft abstracts, manuscripts, and materials for presentation at scientific meetings should be provided to the Sponsor at least 30 working days prior to submission deadlines. Authorship of publications resulting from this study will be based on generally accepted criteria for major medical journals.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000077732 | Fidaxomicin |
| C487655 | OPT 80 |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D061065 | Polyketides |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|
|