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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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21 June 2021 |
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Main ID: |
PACTR202008871179105 |
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Date of registration:
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30/07/2020 |
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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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Praziquantel therapy for Schistosoma manson infection in preschool-aged children
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Scientific title:
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Optimization of praziquantel therapy for Schistosoma mansoni infection in preschool-aged children in Ethiopia: PrazOpt |
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Date of first enrolment:
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01/09/2020 |
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Target sample size:
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218 |
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Recruitment status: |
Other |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12251 |
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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,Non-randomised,Numbered containers
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Phase:
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Not Applicable
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Countries of recruitment
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Ethiopia
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Contacts
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Name:
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Eyasu Makonnen
Eshetu |
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Address:
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Zambia street
Addis Ababa
Ethiopia |
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Telephone:
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+251911247556 |
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Email:
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eyasumakonnen@yahoo.com |
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Affiliation:
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Deputy Head of CDT Africa of Addis Ababa University |
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Name:
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Abebaw Fekadu
Wassie |
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Address:
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Zambia street
Addis Ababa
Ethiopia |
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Telephone:
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+251912894975 |
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Email:
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abebaw.fekadu@aau.edu.et |
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Affiliation:
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Head of CDT Africa of Addis Ababa University |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Written informed consent by parents/guardian
- Age greater than or equal to 48 months and less than or equal to 84 months
- Submission of 2 stool samples at baseline assessment
Exclusion criteria: - Presence of any severe medical problem
- Recent anthelminthic treatment
- Use of other drugs within 5 half-lives of enrolment
- History of hypersensitivity to praziquantel
- Patients with ocular cysticercosis
- Participation in other studies.
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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Schistosomiasis
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Schistosomiasis
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Intervention(s)
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Praziquantel
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Primary Outcome(s)
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cure rate
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Secondary Outcome(s)
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- Egg reduction rate
- Safety and tolerability (adverse events)
- Estimates of pharmacokinetic parameters (AUC, Cmax, Tmax, t1/2, Tlag)
- Correlates of curative outcome
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Source(s) of Monetary Support
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EDCTP
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Ethics review
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Status: Approved
Approval date: 08/03/2020
Contact:
info@ethernet.edu.et
info@ethernet.edu.et
+251118721747
info@ethernet.edu.et
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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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