CTRI/2019/01/016862已完成3 期
A double blind randomized single period parallel placebo controlled comparative efficacy study of Nitazoxanide 500 mg Tablets Test of Rising Pharmaceuticals Inc USA and Alinia Nitazoxanide Tablets Ref of Romark Pharmaceuticals USA in patients â?¥12 years old with diarrhea caused by Giardia lamblia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 320
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
入选标准
- •Infection with Giardia lamblia in immunocompetent male or female patients aged more than or equal to 12 years
- •Patients with diarrhea more than or equal 3 unformed stools per day with one or more enteric symptoms such as abdominal pain or cramps nausea vomiting tenesmus or malabsorption
- •Giardia lamblia cysts detected in a stool specimen obtained during screening
- •Willing to give their patient or legal guardian written informed consent or written informed assent to participate in the study
- •Patients should be stable on their disease for the participation in the study as per the Principal Investigators PI discretion
排除标准
- •An additional intestinal pathogen that might contribute to the presenting symptoms eg pathogenic bacteria such as Salmonella Shigella Entamoeba histolytica Cryptosporidium parvum
- •Administration of drugs known to affect intestinal motility or diarrhea within 7 days of enrollment
- •Stool colony count of more than 10000 Colony forming units CFU per ml for diarrhea causing pathogens
- •Use within 2 weeks of enrollment of any drug or therapy with antiprotozoal activity including 5 nitroimidazoles such as metronidazole tinidazole ornidazole secnidazole paromomycin nitazoxanide azithromycin hydroxyquinoline derivatives acetamide analogues such as diloxanide paromomycin and nitazoxanide Trimethoprim sulfamethoxazole may be used within 2 weeks of enrollment but may not be used concomitantly during therapy
- •Patients known or suspected of having HIV/AIDS
- •Patients with compromised renal or hepatic function
- •Patients with chronic gastrointestinal illness such as IBS or IBD etc
- •Patients with malnutrition defined as a BMI less than 18.5 kg per m2 in adults and BMI < 5% for age based on Centers for Disease Control and Prevention growth chart in adolescents >=12 years of age
- •Concomitant use of warfarin antimicrobial drugs and drugs with antiprotozoan activity other than the study drugs
- •Females who are pregnant suspected of being pregnant or breast feeding urine pregnancy tests are required for all women of childbearing potential or who are two years or less post-menopausal
- •Serious systemic disorders incompatible with the study as per PIs discretion
- •History of hypersensitivity to Nitazoxanide or other sulphur containing drugs like penicillins sulphonamides etc
- •Patients in whom the possibility of receiving a placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patients illness according to the Investigators judgment
- •Patients with known immune deficiencies eg cancer chemotherapy patients patients with hypogammaglobulinemia
研究者
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