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| ID | Type | Description | Link |
|---|---|---|---|
| NTP/Mycograb/003B |
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This is a multicenter, randomized, efficacy and safety trial to evaluate Mycograb®. Subjects will be randomized to one of the 3 arms: 1/ Amphotericin B (0.7 mg/kg/d) plus 5-flucytosine (100 mg /kg/d); 2/ Amphotericin B plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days); 3/ Amphotericin B plus 5-flucytosine plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days). After 2 weeks, all patients will be switched to fluconazole at 400 mg/d for 8 weeks and 200 mg/d thereafter. The total duration of the study will be approximately 24 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Mycograb + Amphotericin B + 5 flucytosine |
|
| 2 | Placebo Comparator | Placebo + Amphotericin B + 5 flucytosine |
|
| 3 | Experimental | Mycograb + Amphotericin B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efungumab (Mycograb) | Biological |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients (receiving Mycograb + Amphotericin B + 5-flucytosine) cured (combined clinical and microbiological response) versus placebo (Amphotericin B + 5-flucytosine) and versus Mycograb + Amphotericin B alone. | day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Mycograb versus placebo. Safety assessment will include: physical examination, vital signs, laboratory parameters, adverse events, serious adverse events. | week 10 | |
| Assess the cerebrospinal fluid (CSF) penetration of Mycograb | Days 3, 7 and 14 |
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Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | South Africa | South Africa |
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| ID | Term |
|---|---|
| D016919 | Meningitis, Cryptococcal |
| ID | Term |
|---|---|
| D016921 | Meningitis, Fungal |
| D020314 | Central Nervous System Fungal Infections |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C512268 | efungumab |
| D000666 | Amphotericin B |
| D005437 | Flucytosine |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
| Amphotericin B | Biological |
|
| 5 flucytosine | Biological |
|
| Determine whether Mycograb + Amphotericin B is as effective as Amphotericin B plus 5-cytosine while avoiding the potential problem of 5-cytosine toxicity. | Day 14 |
| D007239 | Infections |
| D003453 | Cryptococcosis |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| D003596 |
| Cytosine |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |