Contact information
Type
Scientific
Primary contact
Dr Paul Kelly
ORCID ID
Contact details
Tropical Gastroenterology & Nutrition group
University of Zambia
School of Medicine
Lusaka
50398
Zambia
+260 211 252269
m.p.kelly@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RM02-3013
Study information
Scientific title
High dose prolonged treatment with nitazoxanide for the treatment of cryptosporidiosis in children with HIV: a double-blind, randomised placebo-controlled trial
Acronym
Study hypothesis
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.
Ethics approval
Research Ethics Committee of the University of Zambia, School of Medicine. Date of approval: 27/06/2002 (ref: 004-06-02)
Study design
Double-blind, randomised, placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
HIV-related opportunistic infection/ cryptosporidiosis
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
nitazoxanide
Primary outcome measure
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.
Secondary outcome measures
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
Overall trial start date
01/06/2002
Overall trial end date
01/06/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
60
Participant exclusion criteria
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
Recruitment start date
01/06/2002
Recruitment end date
01/06/2004
Locations
Countries of recruitment
Zambia
Trial participating centre
Tropical Gastroenterology & Nutrition group
Lusaka
50398
Zambia
Sponsor information
Organisation
Romark Laboratories (USA)
Sponsor details
6200 Courtney Campbell Causeway
Suite 880
Tampa
33607
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Romark Laboratories (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19954529
Publication citations
-
Results
Amadi B, Mwiya M, Sianongo S, Payne L, Watuka A, Katubulushi M, Kelly P, High dose prolonged treatment with nitazoxanide is not effective for cryptosporidiosis in HIV positive Zambian children: a randomised controlled trial., BMC Infect. Dis., 2009, 9, 195, doi: 10.1186/1471-2334-9-195.