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ISRCTN
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ISRCTN41089957
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ClinicalTrials.gov identifier
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Public title
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Double-blind, placebo-controlled study of nitazoxanide suspension in the treatment of cryptosporidiosis in children with HIV
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Scientific title
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High dose prolonged treatment with nitazoxanide for the treatment of cryptosporidiosis in children with HIV: a double-blind, randomised placebo-controlled trial
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Acronym
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N/A
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Serial number at source
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RM02-3013
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Study hypothesis
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The primary objective of the study is to evaluate the efficacy and safety of nitazoxanide oral suspension compared to a placebo in the treatment of cryptosporidiosis in children with HIV.
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Ethics approval
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Research Ethics Committee of the University of Zambia, School of Medicine. Date of approval: 27/06/2002 (ref: 004-06-02)
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Study design
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Double-blind, randomised, placebo-controlled trial
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Countries of recruitment
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Zambia
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Disease/condition/study domain
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HIV-related opportunistic infection/ cryptosporidiosis
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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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
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Anticipated start date
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01/06/2002
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Anticipated end date
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01/06/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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60
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Interventions
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Nitazoxanide suspension: 200 mg twice a day (bid) for 28 days (if 1-3 years old) or 400 mg bid for 28 days (if 4-11 years old), or matching placebo.
Total duration of follow-up: 4 weeks. However, a provision was included to allow compassionate open-label treatment for children who did not respond. This could have allowed extension of the period of follow-up by 60 days, therefore, it was possible for the children to be followed up for 88 days in total.
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Primary outcome measure(s)
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Proportion of children achieving 'well' clinical response and time to 'well' clinical response. Well response is defined as the patient experiencing no symptoms of C. parvum infection and passing no watery stools within the previous 48 hours.
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Secondary outcome measure(s)
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1. Proportion of children achieving eradication of oocysts of C. parvum from two consecutive stool samples, and time to eradication
2. Time to well clinical response and eradication of oocysts from the stool
3. Mortality at 4 weeks
4. Rate of reduction in diarrhoea frequency based on daily evaluation over 4 weeks
5. Nutritional response (change over time in weight for age z scores, weight for height z scores, height for age z scores and mid-upper arm circumference) based on daily evaluation over 4 weeks
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Sources of funding
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Romark Laboratories (USA)
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Trial website
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Publications
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Contact name
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Dr
Paul
Kelly
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Address
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Tropical Gastroenterology & Nutrition group
University of Zambia
School of Medicine
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City/town
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Lusaka
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Zip/Postcode
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50398
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Country
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Zambia
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Tel
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+260 211 252269
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Fax
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+260 211 252269
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Email
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guts@coppernet.zm
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Sponsor
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Romark Laboratories (USA)
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Address
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6200 Courtney Campbell Causeway
Suite 880
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City/town
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Tampa
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Zip/Postcode
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33607
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Country
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United States of America
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Sponsor website:
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http://www.romark.com
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Date applied
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10/06/2008
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Last edited
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27/06/2008
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Date ISRCTN assigned
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16/06/2008
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