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Combination anti-fungal therapy in cryptococcal meningitis

A randomised controlled trial of combination anti-fungal therapy in cryptococcal meningitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN95123928
Enrollment
300
Registered
2005-07-22
Start date
2004-04-22
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryptococcal meningitis Infections and Infestations Meningitis

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 Gro

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Renal or liver failure 3. Active TB 4. Aged less than 15 years old

Design outcomes

Primary

MeasureTime frame
Mortality at 2 and 10 weeks

Secondary

MeasureTime frame
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

Countries

Viet Nam

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026