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

Completed

Conditions: HIV-related opportunistic infection/ cryptosporidiosis
Infections and Infestations
Other protozoal intestinal diseases

Registration Number: ISRCTN41089957

Lead Sponsor: Romark Laboratories (USA)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

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)

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Proportion of children achieving eradication of oocysts of C. parvum from two consecutive stool samples, and time to eradication <br>2. Time to well clinical response and eradication of oocysts from the stool <br>3. Mortality at 4 weeks <br>4. Rate of reduction in diarrhoea frequency based on daily evaluation over 4 weeks <br>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