High dose prolonged treatment with nitazoxanide for the treatment of cryptosporidiosis in children with HIV: a double-blind, randomised placebo-controlled trial

Romark Laboratories (USA)0 个研究点目标入组 60 人开始时间: 2008年6月16日最近更新: 2015年1月13日

适应症

试验速览

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•1. Both males and females, age 1-11 years
•2. Stool positive for Cryptosporidium parvum using the auramine phenol staining technique (specimen collected within 7 days prior to enrolment)
•3. Patients with diarrhoea (>= 3 unformed stools/day) for each of the 5 days prior to enrolment based on report by the patient, parent or guardian and observation in hospital for at least 24 hours
•4. Patients who are HIV positive by the Capillus Rapid Test (Trinity Biotech, Ireland)

•1. Any investigational drug therapy within 1 month of enrolment
•2. Use within 2 weeks of enrolment of metronidazole, tinidazole, ornidazole, secnidazole, hydroxyquinoline derivatives, diloxanide, paromomycin or nitazoxanide
•3. Patients with positive enzyme immunoassay of faecal sample for Entamoeba histolytica or Giardia lamblia
•4. Serious systemic disorders incompatible with the study

发起方

Romark Laboratories (USA)