ISRCTN30579828进行中（未招募）3 期
Fluconazole plus flucytosine vs fluconazole alone for cryptococcal antigen-positive patients identified through screening: a phase III randomised controlled trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Consecutive patients aged >18 years
- •2. HIV-seropositive
- •3. CD4 count of <100 cells/µl
- •4. Serum/plasma Cryptococcal antigen (CrAg) test positive within the last 14 days
- •5. Cerebrospinal fluid (CSF) CrAg test negative or lumbar puncture not done (declined)
- •6. Willing to participate in the study
排除标准
- •Current exclusion criteria:
- •Initial exclusion criteria:
- •1. Prior episode of cryptococcal meningitis
- •2. Pregnancy (confirmed by urine or serum pregnancy test) or breastfeeding
- •3. Previous serious reaction to flucytosine or fluconazole
- •4. Already taking high-dose fluconazole treatment (800-1200 mg/day) for =1 week
- •5. Contraindicated concomitant medications including cisapride and the class of antihistamines including terfenadine
- •6. HIV-seronegative
- •7. Clinical symptoms/ signs of symptomatic meningitis at any time since CrAg screening, i.e. a progressively severe headache OR a headache and marked nuchal rigidity OR a headache and vomiting OR seizures OR a Glasgow Coma Scale (GCS) score of <15
- •8. Jaundice
- •9. CSF positive for cryptococcal meningitis (i.e. positive microscopy with India Ink, culture, or CrAg test) at any time between the CrAg test and screening for eligibility, while the patient remained without clinical symptoms/ signs of meningitis as described in 7 (late withdrawal criterion)
- •Late exclusion criteria: (after randomisation and day 1 visit)
- •10. DAIDS grade 4 abnormalities of platelets, neutrophil count or creatinine level on baseline bloods:
- •10.1. Platelets <25,000 x 10^6/l
- •10.2. Neutrophils <400 x10^6/l
- •10.3. Creatinine > 3.5x upper limit of normal (with standardised ULN of 114 µmol/l, this
- •includes any creatinine level =400 µmol/l)
- •11. Microbiological evidence of CM on CSF if full CSF results not present at randomisation (e.g. screening CSF CrAg negative but culture on same sample later returns positive for CM)
- •Previous exclusion criteria:
- •1. Prior episode of Cryptococcal meningitis
- •2. Pregnancy (confirmed by urine or serum pregnancy test) or breastfeeding
- •3. Previous serious reaction to flucytosine or fluconazole
- •4. Already taking high-dose fluconazole treatment (800-1200 mg/day) for =1 week
- •5. Contraindicated concomitant medications including cisapride and the class of antihistamines including terfenadine
- •6. HIV-seronegative
- •7. Clinical symptoms/ signs of symptomatic meningitis at any time since CrAg screening, i.e. a progressively severe headache OR a headache and marked nuchal rigidity OR a headache and vomiting OR seizures OR a Glasgow Coma Scale (GCS) score of <15
- •8. Jaundice
- •9. CSF positive for Cryptococcal meningitis (i.e. positive microscopy with India Ink, culture, or CrAg test) at any time between the CrAg test and screening for eligibility, while the patient remained without clinical symptoms/ signs of meningitis as described in 7 (late withdrawal criterion)
研究者
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