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Terminated due to the fact that the required number of trial subjects was not met.
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The objective of this multi-center, prospective observational study is to determine the feasibility of a potential interventional study with fidaxomicin. The incidence and clinical aspects of Clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonates | Neonates with CDAD |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the feasibility of a potential interventional study with fidaxomicin | The incidence and clinical aspects of clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome. | 40 days |
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Inclusion Criteria:
Exclusion Criteria:
Subject will be excluded from participation if any of the following apply:
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Term neonates less than 28 days of age at enrollment, referred to healthcare professionals due to suspected C Difficile Associated Disease (CDAD).
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Manager | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site: 3301 | Poissy | Paris | 92141 | France | ||
| Site: 3302 |
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Stool Sample
| Lyon |
| 69677 |
| France |
| Site: 4902 | Erlangen | 91054 | Germany |
| Site: 4904 | Hanover | 30625 | Germany |
| Site: 4901 | Munich | 80337 | Germany |
| Site: 3102 | Maastricht | 6229HX | Netherlands |
| Site: 3403 | Granada | 18014 | Spain |
| Site: 3402 | Madrid | 28046 | Spain |
| Site: 3401 | Valencia | 46026 | Spain |