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The study aims to describe the characteristics and the methods of management and follow-up of patients treated with fidaxomicin for Clostridium difficile infection (CDI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: CDI in patients treated with fidaxomicin | Diagnosed with a CDI and treated with fidaxomicin |
| |
| 2: CDI in patients receiving treatment other than fidaxomicin | Diagnosed with a CDI, regardless of the prescribed treatment (not fidaxomicin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fidaxomicin | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Characteristics of patients treated with fidaxomicin, including demographic data, description of comorbidities and treatment by antibiotherapy | Day 1 | |
| Characteristics of the CDI treated with fidaxomicin, including date of CDI diagnosis, department requesting the diagnosis of CDI, methods used, severity of CDI and origin of the case | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic management of the CDI, including the starting date of the treatment, CDI treatment first line and associated treatment | For patients treated with fidaxomicin | Day 1 |
| Number and timing of recurrences in patients treated with fidaxomicin over a 3-month follow-up period |
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Inclusion Criteria:
Exclusion Criteria:
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Adult hospitalized patients diagnosed with clostridium difficile infection
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| Name | Affiliation | Role |
|---|---|---|
| Medical and Scientific Affairs manager | Astellas Pharma S.A.S. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site | Béthune | France | ||||
| Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34162264 | Derived | Guery B, Berger P, Gauzit R, Gourdon M, Barbut F; DAFNE study group; Dafne Study Group, Bemer P, Bessede E, Camou F, Cattoir V, Couzigou C, Descamps D, Dinh A, Laurans C, Lavigne JP, Lechiche C, Leflon-Guibout V, Le Monnier A, Levast M, Mootien JY, N'Guyen Y, Piroth L, Prazuck T, Rogeaux O, Roux AL, Vachee A, Vernet Garnier V, Wallet F. A prospective, observational study of fidaxomicin use for Clostridioides difficile infection in France. J Int Med Res. 2021 Jun;49(6):3000605211021278. doi: 10.1177/03000605211021278. |
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| Treatment for CDI other than fidaxomicin Type | Drug | Oral |
|
| End of the follow-up (3 months) |
| Adverse events and serious adverse events occurring on fidaxomicin | End of the follow-up (3 months) |
| Characteristics of patients diagnosed with CDI, including demographic data and treatment by antibiotherapy | For all patients diagnosed with CDI regardless of treatment | Day 1 |
| Characteristics of the CDI, including date of CDI diagnosis, Department requesting the diagnosis of CDI, methods used, severity of CDI and origin of the case | For all patients diagnosed with CDI regardless of treatment | Day 1 |
| Treatment of the CDI including treatment selected and dosage | For all patients diagnosed with CDI regardless of treatment | Day 1 |
| Bordeaux |
| France |
| Site | Boulogne-Billancourt | France |
| Site | Caen | France |
| Site | Chambéry | France |
| Site | Clermond-Ferrand | France |
| Site | Clichy | France |
| Site | Dijon | France |
| Site | Garches | France |
| Site | La Tronche | France |
| Site | Lille | France |
| Site | Lyon | France |
| Site | Marseille | France |
| Site | Morlaix | France |
| Site | Mulhouse | France |
| Site | Nantes | France |
| Site | Nîmes | France |
| Site | Orléans | France |
| Site | Paris | France |
| Site | Poitiers | France |
| Site | Reims | France |
| Site | Rennes | France |
| Site | Roubaix | France |
| Site | Soissons | France |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077732 | Fidaxomicin |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D061065 | Polyketides |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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