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| Name | Class |
|---|---|
| CHU Kamenge, BURUNDI | UNKNOWN |
| Hospital Avicenne | OTHER |
| Institut Pasteur | INDUSTRY |
| Hôpital Necker-Enfants Malades |
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The aim of the trial is to demonstrate that in a sub-Saharan African setting, the association of:
can decrease mortality rate below 35% at 10 weeks.
This is a non-randomized open label pilot study, with standardized management of cryptococcoses meningitis and follow-up in Burundi and Ivory Coast. A total of 41 patients will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral treatment | Other | Drug: Fluconazole and flucytosine Induction treatment for 2 weeks: Fluconazole (1600mg/j) + flucytosine (100 mg/kg/j) lumbar punctures to control intracranial pressure Consolidation treatment for 8 weeks: fluconazole (800 mg/j) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluconazole | Drug | Induction treatment for 2 weeks: Fluconazole (1600mg/j) Consolidation treatment for 8 weeks: fluconazole (800 mg/j) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | 14 days and 24 weeks | |
| Percentage of patients with negative cerebrospinal fluid (CSF) cultures | 14 days and 10 weeks | |
| Number of relapses of cryptococcal throughout the monitoring period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Bouchaud, PhD | Hopital Avicenne, Service des maladies infectieuses, Paris, france | Study Chair |
| Théodore Niyangobo, PhD | CHU Kamenge, Bujumbura, Burundi | Study Chair |
| Amélie Chabrol, MD | Hopital Avicenne, Service des maladies infectieuses, Paris, france | Principal Investigator |
| Kakou AKA, Professor | CHU Triechville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Kamenge | Bujumbura | Burundi | ||||
| Hôpital Prince Régent Charles |
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| Label | URL |
|---|---|
| Sponsor web page | View source |
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| OTHER |
| Institut de Médecine et Epidémiologie Appliquée (IMEA) | UNKNOWN |
| Hôpital de Treichville | UNKNOWN |
| Hôpital Cocody | UNKNOWN |
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| Flucytosine | Drug | Flucytosine (100 mg/kg/j) for 2 weeks |
|
| lumbar punctures | Procedure | lumbar punctures to control intracranial pressure |
|
| up to 24 weeks |
| Number of "Immune Reconstitution Inflammatory Syndrome" (IRIS) throughout the monitoring period | The IRIS diagnosis criteria will be those given in: Bicanic T, et al. Immune Reconstitution Inflammatory Syndrome in HIV-associated cryptococcal meningitis: a prospective study, J Acquir Immune Defic Syndr 2009; 51:130-134. | up to 24 weeks |
| Number and severity of adverse events | up to 24 weeks |
| Cerebrospinal fluid pressure evolution | up to 24 weeks |
| Percentage of patients with undetectable viral load | 24 weeks |
| CD4 count | 24 weeks |
| Concentration of flucytosine in cerebrospinal fluid | 28 days or 10 weeks |
| Sensitivity of cryptococcal antigen by strip method LFA (lateral-flow immunoassay) | on urines, plasma, CSF and whole blood fingerstick | at study entry |
| CSF total volume discharged | up to 24 weeks |
| Number of lumbar punctures performed | up to 24 weeks |
| Concentration of fluconazole in plasma | 28 days or 10 weeks |
| Concentration of fluconazole in cerebrospinal fluid | 28 days or 10 weeks |
| Concentration of flucytosine in plasma | 28 days or 10 weeks |
| MICs of fluconazole | MICs of fluconazole for cryptococcus strains, if CSF cultures ar positive at 28 days or 10 weeks or in case of relapse | 28 days |
| Bujumbura |
| Burundi |
| Hôpital général | Bururi | Burundi |
| Hôpital général | Kayanza | Burundi |
| Hôpital général | Muyinga | Burundi |
| Service de Maladies Infectieuses & Tropicales - Hôpital Triechville | Abidjan | Côte d’Ivoire |
| Service de Neurologie - Hôpital Cocody | Abidjan | Côte d’Ivoire |
| ID | Term |
|---|---|
| D016919 | Meningitis, Cryptococcal |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D016921 | Meningitis, Fungal |
| D020314 | Central Nervous System Fungal Infections |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003453 | Cryptococcosis |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D015725 | Fluconazole |
| D005437 | Flucytosine |
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003596 | Cytosine |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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