Condition category
Infections and Infestations
Date applied
10/06/2008
Date assigned
16/06/2008
Last edited
15/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.romark.com

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19954529

Publication citations

  1. 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.

Additional files

Editorial Notes