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11 February 2012
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| [ Print-friendly version ] |
| Combination anti-fungal therapy in cryptococcal meningitis |
| ISRCTN | ISRCTN95123928 |
| ClinicalTrials.gov identifier | |
| Public title | Combination anti-fungal therapy in cryptococcal meningitis |
| Scientific title | A randomised controlled trial of combination anti-fungal therapy in cryptococcal meningitis |
| Acronym | BK Study |
| Serial number at source | 061330 |
| Study hypothesis |
Cryptococcal meningitis is the second leading cause of death in Human Immunodeficiency Virus (HIV) patients worldwide after Tuberculosis (TB). The Hospital for Tropical Diseases has seen a dramatic increase in the number of cases of cryptococcal meningitis as the HIV epidemic has accelerated in Viet Nam. The mortality rate is high, even with treatment according to international guidelines. Optimum treatment for cryptococcal meningitis is not determined. Combination treatment with amphotericin and flucytosine has shown no clinical benefit when compared with amphotericin alone, yet this combination of potentially toxic drugs has become the standard of care, recommended in US and European guidelines.
The azole drugs, with their ease of administration and good safety profile, have not been investigated in combination with amphotericin in the treatment of cryptococcal meningitis. The trial will determine whether amphotericin combined with high dose fluconazole is superior to amphotericin alone or amphotericin combined with flucytosine, using clinical endpoints. As of 18/03/2009 the anticipated trial dates of this record have been updated; the intial trial dates at the time of registration were: Initial anticipated start date: 01/04/2004 Initial anticipated end date: 01/01/2006 |
| Lay summary | |
| Ethics approval |
The ethical review board of the Hospital for Tropical Diseases, Ho Chi Minh City, and Liverpool School of Tropical Medicine, UK gave approval prior to participant recruitment.
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| Study design | Open label randomised controlled trial |
| Countries of recruitment | Viet Nam |
| Disease/condition/study domain | Cryptococcal meningitis |
| Participants - inclusion criteria |
1. Patients aged 15 years and older
2. HIV positive 3. Cryptococcal meningitis defined by a clinical syndrome consistent with cryptococcal meningitis and one or more of: positive Cerebrospinal Fluid (CSF) culture, positive cryptococcal antigen in CSF, positive CSF india ink test |
| Participants - exclusion criteria |
1. Pregnancy
2. Renal or liver failure 3. Active TB 4. Aged less than 15 years old |
| Anticipated start date | 22/04/2004 |
| Anticipated end date | 01/12/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 300 (237 as of March 2009) |
| Interventions |
Treatment Group 1:
Induction Treatment: Amphotericin 1 mg/kg/day for 4 weeks Consolidation Treatment: Fluconazole 400 mg/day for 6 weeks Secondary Prophylaxis: Fluconazole 200 mg/day Treatment Group 2: Induction Treatment: Amphotericin 1 mg/kg/day plus flucytosine 100 mg/kg/day for 2 weeks Consolidation Treatment: Fluconazole 400 mg/day for 8 weeks Secondary Prophylaxis: Fluconazole 200 mg/day Treatment Group 3: Induction Treatment: Amphotericin 1 mg/kg/day plus Fluconazole 800 mg/day for 2 weeks Consolidation Treatment: Fluconazole 400 mg/day for 8 weeks Secondary Prophylaxis: Fluconazole 200 mg/day |
| Primary outcome measure(s) | Mortality at 2 and 10 weeks |
| Secondary outcome measure(s) |
Amended as of 19/03/2009:
1. Rates of disability at 10 weeks 2. Rates of clearance of yeasts from CSF at 6 months 3. Changes in immune parameters at 6 months 4. Combined death and disability at 6 months 5. Death at 6 months Initial information at the time of registration: 1. Duration of ventilation 2. Duration of supplemental oxygen 3. Duration of hospitalisation 4. Viral load in clinical specimens 5. Cytokine levels 6. Adverse effects |
| Sources of funding | The Wellcome Trust (UK) (grant ref: 061330) |
| Trial website | |
| Publications | |
| Contact name | Dr Jeremy Farrar |
| Address |
Hospital for Tropical Diseases
The Hospital for Tropical Diseases Oxford University Clinical Research 190 Ben Ham Tu |
| City/town | Ho Chi Minh City |
| Zip/Postcode | 5 |
| Country | Viet Nam |
| Tel | +84 88362225 |
| Fax | +84 89238904 |
| jeremyjf@hcm.vnn.vn | |
| Sponsor | University of Oxford (UK) |
| Address |
University Offices
Wellington Square |
| City/town | Oxford |
| Zip/Postcode | OX1 2JD |
| Country | United Kingdom |
| Tel | +44 (0)1865 270143 |
| Fax | +44 (0)1865 280467 |
| research.services@admin.ox.ac.uk | |
| Sponsor website: | http://www.ox.ac.uk |
| Date applied | 22/07/2005 |
| Last edited | 19/03/2009 |
| Date ISRCTN assigned | 22/07/2005 |
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