ISRCTN38290380已完成未知
Efficacy of primaquine against Plasmodium vivax relapses when combined with dihydroartemisinin-piperaquine or quinine in Indonesian soldiers
Eijkman-Oxford Clinical Research Unit (Indonesia)0 个研究点目标入组 240 人开始时间: 2012年5月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 240
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
- Male
入选标准
- •1. Male patients between the age of 18 and 60 years
- •2. Traveled for >1 month to north eastern Papua within the past 12 months
- •3. Body weight > 40 kg and = 90 kg
- •4. Presence of P. vivax parasitemia mono- or mixed infection with another plasmodial species confirmed by positive microscopy of P. vivax with parasite density =20/ µL of blood
- •5. Written informed consent provided by patient. If the patient was unable to write, witnessed consent was permitted
- •6. Glucose-6-phosphate dehydrogenase (G6PD) normal using the nicotinamide adenine dinucleotide phosphate-oxidase (NADPH) qualitative fluorescent spot test (Trinity Biologicals, USA)
- •7. Able to swallow oral medication
- •8. Able and willing to participate based on information given to patient
排除标准
- •1. Presence of clinical condition requiring hospitalization
- •2. Presence of significant anaemia, as defined by Hb < 8 g/dL
- •3. G6PD deficient determined by a standard qualitative test
- •4. Definite plans for an absence of 3 days or more from the base within 28 days of being enrolled
- •5. Known history or evidence of clinically significant disorders:
- •5.1. Cardiovascular
- •5.2. A corrected QT interval (QTc) >450 ms*
- •5.3. Respiratory, including active tuberculosis
- •5.4. Hepatic
- •5.5. Renal
- •5.6. Gastrointestinal
- •5.7. Immunological
- •5.8. Neurological, including hearing impairment
- •5.9. Endocrine
- •5.10. Infectious
- •5.11. Malignancy
- •5.12. Psychiatric
- •6. Recent head trauma
- •7. Any other clinically significant finding that the investigator judges will place the patient at risk or interfere with the study results
- •8. Known to have or be confirmed:
- •8.1. Active Hepatitis A (e.g. by detection of anti HAV-IgM)
- •8.2. Hepatitis B surface antigen (HBsAg) carrier
- •8.3. Hepatitis C antibody (HCV Ab).
- •9. Liver function tests (AST/ALT levels) more than 2.5 times the upper limit of normal range
- •10. Renal impairment as indicated by abnormal creatinine clearance of < 60 ml/min, measured using Cockcroft-Gault formula
- •11. Known history of hypersensitivity, allergy or adverse reactions to piperaquine, quinine or primaquine, artesunate, dihydroartemisinin (DHA) or other artemisinins
- •12. Previous participation in the present clinical trial with DHA/PQP
- •13. Had received any investigational drug within the past 4 weeks
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