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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003002-32 | EudraCT Number |
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The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI).
This study will also compare CDI clinical response to the microbiological response in terms of magnitude of reduction of C. difficile total viable count and spore count during treatment with FDX and if achieved; the time to microbial eradication; determine time to negative CDI toxin assay in stool specimens during treatment with FDX; assess the stool concentrations of FDX and metabolite OP-1118 throughout therapy; assess the length of hospital stay, readmissions and resource utilization for IBD patients receiving FDX; record the incidence and severity of Adverse Events (AEs) and document the impact of treatment on Quality of Life as measured by the changes in Short Inflammatory Bowel Disease Questionnaire (IBDQ) score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fidaxomicin | Experimental | tablet twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fidaxomicin | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter of fidaxomicin: Maximum plasma concentration (Cmax) | Day 1, Day 5 and Day 10 | |
| Pharmacokinetic parameter of OP-1118: Maximum plasma concentration (Cmax) | Day 1, Day 5 and Day 10 | |
| Pharmacokinetic parameter of fidaxomicin: Area under the curve from 0 to 12 hrs (AUC12) | Day 1 | |
| Pharmacokinetic parameter of OP-1118: Area under the curve from 0 to 12 hrs (AUC12) | Day 1 | |
| Pharmacokinetic parameter of fidaxomicin and OP-1118: Metabolite to Parent Ratio (MPR) | Day 1 | |
| Pharmacokinetic parameter of fidaxomicin: Area under the concentration-time curve from the time of dosing to the start of the next dosing interval (AUCtau) | Day 5 and Day 10 | |
| Pharmacokinetic parameter of OP-1118: Area under the concentration-time curve from the time of dosing to the start of the next dosing interval (AUCtau) | Day 5 and Day 10 | |
| Pharmacokinetic parameter of fidaxomicin: The time after dosing when Cmax occurs (tmax) | Day 1, Day 5 and Day 10 | |
| Pharmacokinetic parameter of OP-1118: The time after dosing when Cmax occurs (tmax) | Day 1, Day 5 and Day 10 | |
| Measure | Description | Time Frame |
|---|---|---|
| CDI clinical response | Day 12 | |
| Microbiological response of C. difficile total viable count, spore count, microbiological eradication and negative CDI toxin assay | Day 5 and Day 10 | |
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Inclusion Criteria:
Confirmed diagnosis or history of IBD for at least 3 months
Subject has have active IBD defined by :
CDI confirmed positive according to local standard testing for the presence of C. difficile within 48 hr prior to enrollment
Female subject is not breastfeeding at Screening or while participating in this study
Subject agrees to practice effective birth control from Screening and while participating in this study
Subject agrees not to participate in another interventional study while participating in this study
Male partner agrees not to donate sperm starting at screening and throughout the investigational period.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Astellas Pharma Europe Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site AT43001 | Graz | 8036 | Austria | |||
| Site FR33002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30260412 | Derived | Hogenauer C, Mahida Y, Stallmach A, Marteau P, Rydzewska G, Ivashkin V, Gargalianos-Kakolyris P, Michon I, Adomakoh N, Georgopali A, Tretter R, Karas A, Reinisch W. Pharmacokinetics and safety of fidaxomicin in patients with inflammatory bowel disease and Clostridium difficile infection: an open-label Phase IIIb/IV study (PROFILE). J Antimicrob Chemother. 2018 Dec 1;73(12):3430-3441. doi: 10.1093/jac/dky368. |
| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| Pharmacokinetic parameter of fidaxomicin: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F) |
| Day 5 and Day 10 |
| Pharmacokinetic parameter of OP-1118: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F) | Day 5 and Day 10 |
| Pharmacokinetic parameter of fidaxomicin: Concentration immediately prior to dosing at multiple dosing (Ctrough) | Day 5 and Day 10 |
| Pharmacokinetic parameter of OP-1118: Concentration immediately prior to dosing at multiple dosing (Ctrough) | Day 5 and Day 10 |
| Stool concentrations of fidaxomicin and its metabolite OP-1118 |
| Day 1, Day 5 and Day 10 |
| Length of hospital stay, readmissions and resource utilization | up to Day 180 |
| Safety as assessed by incidence and severity of adverse events | up to Day 180 |
| Health related quality of life as assessed by short IBDQ score | Inflammatory Bowel Disease Questionnaire (IBDQ) | Day 10, Day 26, Day 40, Day 90 and Day 180 |
| Clichy |
| 92110 |
| France |
| Site FR33001 | Paris | 75012 | France |
| Site GR30004 | Athens | 11527 | Greece |
| Site IT39003 | Padova | 35128 | Italy |
| Site IT39001 | Roma | Italy |
| Site PL48002 | Warsaw | 02-507 | Poland |
| Site PL48003 | Warsaw | 02-781 | Poland |
| Site RU70003 | Moscow | 119435 | Russia |
| Site RU70002 | Moscow | 129110 | Russia |
| Site RU70001 | Saint Petersburg | 196247 | Russia |
| Site GB44002 | London | E11 1NR | United Kingdom |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077732 | Fidaxomicin |
| C487655 | OPT 80 |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D061065 | Polyketides |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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