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document
Effect of nitazoxanide on morbidity and mortality in Zambian children with cryptosporidiosis : a randomised controlled trial . BACKGROUND Cryptosporidiosis in children in developing countries causes persistent diarrhoea and malnutrition and is associated with increased mortality , but there is no effective treatment . We aimed to assess the effect of nitazoxanide-a new broad-spectrum antiparasitic drug-on morbidity and mortality in Zambian children with diarrhoea due to Cryptosporidium parvum . METHODS Children with cryptosporidial diarrhoea who were admitted to the University Teaching Hospital , Lusaka , Zambia , between November , 2000 , and July , 2001 , and whose parents consented to their having an HIV test were randomly assigned nitazoxanide ( 100 mg twice daily orally for 3 days ) or placebo . The primary endpoint was clinical response on day 7 after the start of treatment . Secondary endpoints included parasitological response by day 10 and mortality at day 8 . Analysis was by intention to treat , with exclusion of patients subsequently found to be negative for C parvum or co-infected at baseline . The trial was stratified by HIV serology . FINDINGS 50 HIV-seropositive and 50 HIV-seronegative children were recruited for the study , four of whom were subsequently excluded . In HIV-seronegative children , diarrhoea resolved in 14 ( 56 % ) of 25 receiving nitazoxanide and 5 ( 23 % ) of 22 receiving placebo ( difference 33 % , 95 % CI 7-59 ; p=0.037 ) . C parvum was eradicated from stool in 13 ( 52 % ) of 25 receiving nitazoxanide and three ( 14 % ) of 22 receiving placebo ( 38 % , 95 % CI 14-63 ; p=0.007 ) . Four children ( 18 % ) of 22 in the placebo group had died by day 8 , compared with none of 25 in the nitazoxanide group ( -18 % , -34 to 2 ; p=0.041 ) . HIV-seropositive children did not benefit from nitazoxanide . Nitazoxanide was not significantly associated with adverse events in either stratum . INTERPRETATION A 3-day course of nitazoxanide significantly improved the resolution of diarrhoea , parasitological eradication , and mortality in HIV-seronegative , but not HIV-seropositive , children .
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Intervention_Pharmacological
nitazoxanide
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Intervention_Physical
nitazoxanide-a
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Intervention_Pharmacological
nitazoxanide
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Intervention_Control
placebo
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Outcome_Mortality
morbidity and mortality
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Outcome_Mortality
morbidity and mortality
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Outcome_Other
clinical response on day 7
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Outcome_Mortality
parasitological response by day 10
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Outcome_Mortality
mortality at day 8
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Outcome_Physical
diarrhoea
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Outcome_Physical
C parvum
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Outcome_Mortality
died
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Outcome_Adverse-effects
adverse events
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Outcome_Mortality
resolution of diarrhoea
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Outcome_Adverse-effects
, parasitological eradication , and mortality
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Participant_Condition
Zambian
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Participant_Age
children
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Participant_Condition
cryptosporidiosis
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Participant_Condition
Cryptosporidiosis
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Participant_Age
children
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Participant_Condition
developing countries
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Participant_Condition
Zambian
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Participant_Age
children
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Participant_Condition
diarrhoea due to Cryptosporidium parvum
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Participant_Age
Children
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Participant_Condition
cryptosporidial diarrhoea
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Participant_Condition
C parvum
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Participant_Sample-size
50
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Participant_Sample-size
50
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Participant_Age
children