Double-blind, placebo-controlled study of nitazoxanide suspension in the treatment of cryptosporidiosis in children with HIV

ISRCTN	ISRCTN41089957
DOI	https://doi.org/10.1186/ISRCTN41089957
Protocol serial number	RM02-3013
Sponsor	Romark Laboratories (USA)
Funder	Romark Laboratories (USA)

Submission date: 10/06/2008
Registration date: 16/06/2008
Last edited: 15/03/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Kelly
Scientific

Tropical Gastroenterology & Nutrition group
University of Zambia
School of Medicine
Lusaka
50398
Zambia

Phone	+260 211 252269
Email	m.p.kelly@qmul.ac.uk

Study information

Primary study design	Interventional
Study design	Double-blind, randomised, placebo-controlled trial
Secondary study design	Randomised controlled trial
Scientific title	High dose prolonged treatment with nitazoxanide for the treatment of cryptosporidiosis in children with HIV: a double-blind, randomised placebo-controlled trial
Study objectives	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(s)	Research Ethics Committee of the University of Zambia, School of Medicine. Date of approval: 27/06/2002 (ref: 004-06-02)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	nitazoxanide
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/06/2004

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	11 Years
Sex	All
Target sample size at registration	60
Key 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)
Key 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
Date of first enrolment	01/06/2002
Date of final enrolment	01/06/2004

Locations

Countries of recruitment

Zambia

Study participating centre

Tropical Gastroenterology & Nutrition group

Lusaka
50398
Zambia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/12/2009		Yes	No