ISRCTN18180872进行中（未招募）2 期
Population-pharmacokinetics, safety and tolerability of sustained-release flucytosine pellets for the treatment of asymptomatic cryptococcal antigen-positive individuals: a single-arm trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
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 <200 cells/µl
- •4. Serum/plasma CrAg test positive within the last 21 days
- •5. CSF CrAg test negative or LP not done (declined)
- •6. Willing to participate in the study
排除标准
- •1. Prior episode of CM or cryptococcal antigenaemia
- •2. Pregnancy (confirmed by urine or serum pregnancy test) or breastfeeding
- •3. Women of childbearing potential who do not agree to use contraception during the study period.
- •4. Male participants (or their female partners of childbearing potential) who do not agree to use effective contraception during the study period.
- •5. Already taking high-dose fluconazole treatment (800-1200 mg/day) for =10 days
- •6. Known dihydropyridine dehydrogenase (DPD) deficiency
- •7. Previous serious reaction to flucytosine or fluconazole
- •8. Contraindicated concomitant medications including: cisapride and the class of antihistamines including terfenadine
- •9. HIV-seronegative
- •10. 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
- •11. CSF positive for CM (i.e. positive microscopy with India Ink, culture, or CrAg test) at any time between the CrAg test and screening for eligibility
- •12. Jaundice
- •13. Participants <40 kg or BMI<16 (with severe signs of malnutrition)
- •14. History of radiotherapy
- •15. Additional serious or life-threatening disease or HIV-related complications or co-morbidities (notably, diseases affecting gastrointestinal tract and participants likely to die within 14 days from conditions other than cryptococcal disease) based on the opinion of the investigator
- •16. Absolute neutrophil count of <500 x 106/L on baseline blood testing
- •17. Platelets <50,000x106/L on baseline blood testing
- •18. Creatinine clearance; eGFR < 60 ml/min on baseline blood testing (calculation method Cockroft/Gault)
- •19. Hepatic impairment (transaminases >3x upper limit of normal) on baseline blood testing
- •20. Participants should be excluded in case of any severe medical or psychiatric condition that may increase the risk associated with trial participation or may interfere with the interpretation of trial results.
- •21. Late exclusion criteria: Microbiological evidence of CM on CSF if full CSF results are not available at randomisation (e.g. screening CSF CrAg negative but culture on the same sample later returns positive for CM)
研究者
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