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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201612001914353 |
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Date of registration:
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07/12/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Optimization of Schistosomiasis treatment in Tanzania
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Scientific title:
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Efficacy and Safety of Praziquantel combined with Dihydroartemisinin-Piperaquine for the treatment of schistosomiasis; Pharmacokinetics and Pharmacogenetics implications of the drugs combination in Tanzania |
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Date of first enrolment:
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02/01/2017 |
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Target sample size:
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600 |
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Recruitment status: |
Other |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1914 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a radomisation table created by a computer software program,Sealed opaque envelopes
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Phase:
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Not Applicable
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Countries of recruitment
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Tanzania
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Contacts
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Name:
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Joyce
Masalu |
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Address:
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United Nation Road
11103
Dar es Salaam
Tanzania |
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Telephone:
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+255222152489 |
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Email:
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drp@muhas.ac.tz |
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Affiliation:
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Director of Research Publicatiom-MUHAS |
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Name:
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Omary
Minzi |
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Address:
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United Nation Road
11103
Dar es Salaam
Tanzania |
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Telephone:
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+255785892009 |
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Email:
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minziobejayesu@gmail.com |
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Affiliation:
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Supervisor |
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Key inclusion & exclusion criteria
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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
Age minimum:
2 Year(s)
Age maximum:
5 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sschistosomiasis
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Malaria
Sschistosomiasis
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Malaria
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Intervention(s)
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Combination therapy PZQ plus DHP
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PZQ alone
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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Pharmacogenetics of PZQ ad DHP for the presence of single nucleotide polymorphisim (SNPs)
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DHP and PZQ interaction (drug level)
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safety + tolerability of the new intervention (adverse events)
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day 7 piperaquine plasma concetration + malaria treatment outcome using DHP in the presence of PZQ
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Source(s) of Monetary Support
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Sida grant -MUHAS
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Ethics review
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Status: Approved
Approval date: 25/05/2016
Contact:
drp@muhas.ac.tz
Muhumbili University of Health and Allied Sciences Etyhical Review Board
+255222150302
drp@muhas.ac.tz
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Status: Approved
Approval date: 07/11/2016
Contact:
headquarters@nimr.or.tz
National Institute of Medical Research Ethical commitee
255222120262
headquarters@nimr.or.tz
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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