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Optimization of Schistosomiasis treatment in Tanzania

Not Applicable
Conditions
Malaria
Sschistosomiasis
Registration Number
PACTR201612001914353
Lead Sponsor
Muhumbili University of Health and Allied Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Other
Sex
All
Target Recruitment
600
Inclusion Criteria

1. School children aged 5-15 years, both male and females 2. Live primarily in a study village/area. 3. School children confirmed schistosomiasis positive by urine filtration test for urinary schistosomiasis and kato-katz for intestinal schistosomiasis 4. School children confirmed malaria positive or negative by microscopy 5.Parent/s has/have consented for child to recruited in this study 6. The child has assented to participate 7. No Known or documented sensitivity to any of the drugs under test

Exclusion Criteria

1. Patients without diagnosis of Schistosomiasis (tested negative for schistosomiasis) 2.A recent PZQ treatment before entry to the study(2 months) 3. Presence of danger signs and symptoms of severe malaria according to WHO criteria 4. Prior treatment of malaria within 14 days of study enrollement 5. Patient receiving any medication known to affect cytochrome P450 within 14 days of the study enrollement 6. Pregnant women

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Schistosomiasis treatment outcome defined as presence or absence of eggs in urine or stool at 1 month and 2moths period netween the new intervention(PZq+DHP) and PZQ alone arms
Secondary Outcome Measures
NameTimeMethod
DHP and PZQ interaction (drug level);Pharmacogenetics of PZQ ad DHP for the presence of single nucleotide polymorphisim (SNPs);day 7 piperaquine plasma concetration + malaria treatment outcome using DHP in the presence of PZQ;safety + tolerability of the new intervention (adverse events)
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