None listed
Conditions
Interventions
Group 1 Type of group
10ml (4-11y) or 5ml (1-3y) of 100mg / 5ml of pediatric suspension with nitazoxanide strawberry flavoring in the morning and afternoon for three consecutive days
Group name:Group 2 Type of group
10ml (4-11y) or 5ml (1-3y) of placebo, pediatric suspension, morning and afternoon in 3 consecutive days.
Sponsors
ASOCIACION BENEFICA PRISMA,
Eligibility
Inclusion criteria
Inclusion criteria: • Age 1-11 years. • Use of the positive enzyme immunoassay test (The Triage @ Parisite Panel) for Cryptosporidium sp. in stool sample collected up to 7 days before admission. • Patients with diarrhea (> 4 stools / day with or without other symptoms such as tenesmus, bloody stools, rectal bleeding or megacolon.
Exclusion criteria
Exclusion criteria: • Any therapy using a study drug for one month prior to admission. • Use within 2 weeks prior to admission of any therapy with antiprotozoal activity including 5-nitro-imidazoles such as metronidazole, tinidazole, omidazole, secnidazole, hydroxyquinolone derivatives, tremethoprimsulfamethoxazole and acetamide analogues such as diloxanide, paramomycin and nitazoxanide. • Positive patients to the enzymatic test in stool sample to Entamoeba histolytica or Girada lambia. • Serious synthetic disorders incompatible with the study. • History of hypersensitivity to nitazoxanide, metronidazole or nitrolmidazoles. • Patients in whom the possibility of receiving a placebo or of not receiving therapy immediately for an effective treatment, is compatible with the severity of the disease in the patient according to the criteria of the investigators. • Patients known or suspected of AIDS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation of signs and symptoms Measure:Clinical response (resolution of diarrhea) Timepoints:7 to 10 days after the treatment ended ; Outcome name:stool culture Measure:Eradication of C.panoim cysts in the stool, after treatment Timepoints:7 to 10 days after the treatment ended | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Time from the beginning of treatment until the last not formed deposition. Measure:Duration of diarrhea Timepoints:From the beginning of treatment until the last not formed deposition. | — |
Outcome results
None listed