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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRA-CT 2007-004444-71 |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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To assess the safety of Ambisome 10 mg/kg/week in patients as a preemptive treatment in intensive care patients with a sepsis and rising candida colonisation.
Preemptive treatment (i.e., prophylactic treatment with two high doses of Ambisome® administered with an interval of one week, in patiens with a high risk of developing a fungal infection) should decrease the incidence of actual systemic infections.
The incidence of such actual fungal infections will be assessed directly and its impact on patients' survival and intensive care resourches assessed
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amphotericine in liposome (Ambisome®) | Drug | 2 IV infusions separated by one week 10 mg/kg per injection |
| Measure | Description | Time Frame |
|---|---|---|
| Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects | 28-day observation period |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of stay in the intensive care unit; occurrence of a systemic fungal infection | 28 days after first treatment administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-François RI DREYFUS, MD PhD | Contact | 33-61-282-6780 | jfdreyfus@aol.com |
| Name | Affiliation | Role |
|---|---|---|
| Elie AZOULAY, MD PhD | University Teaching Hospital Saint Louis, Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Michallon | Recruiting | Grenoble | 38000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28531175 | Derived | Azoulay E, Timsit JF, Lautrette A, Legriel S, Max A, Ruckly S, Misset B, Cohen Y, Wolff M. Weekly high-dose liposomal amphotericin B (L-AmB) in critically ill septic patients with multiple Candida colonization: The AmBiDex study. PLoS One. 2017 May 22;12(5):e0177093. doi: 10.1371/journal.pone.0177093. eCollection 2017. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| C536972 | Torulopsis |
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008081 | Liposomes |
| C068538 | liposomal amphotericin B |
| ID | Term |
|---|---|
| D008567 | Membranes, Artificial |
| D001697 | Biomedical and Dental Materials |
| D004337 | Drug Carriers |
| D004304 | Dosage Forms |
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| Hopital Saint Louis | Not yet recruiting | Paris | 75010 | France |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001423 | Bacterial Infections and Mycoses |
| D004364 |
| Pharmaceutical Preparations |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D040761 | Biomimetic Materials |