Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201612001914353 Date of Approval: 07/12/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Optimization of Schistosomiasis treatment in Tanzania
Official scientific title Efficacy and Safety of Praziquantel combined with Dihydroartemisinin-Piperaquine for the treatment of schistosomiasis; Pharmacokinetics and Pharmacogenetics implications of the drugs combination in Tanzania
Brief summary describing the background and objectives of the trial Background information Despite the use of PZQ for mass treatment and disease control, the prevalence of schistosomiasis remains high in endemic settings . In several studies done in Africa low cure rates with the use of mass PZQ have been reported. The reported high prevalence of this disease in the endemic countries raises a concern on the current efficacy of PZQ. Treatment failure is thought to be poor activity of PZQ against immature schistosomes as PZQ is only effective against mature schistosoma species. Artemisinin derivatives have been proven to be effective against immature schistosomes. However, in malaria endemic setting, the use of artemisinin for schistosomiasis treatment without being combined with long half-life partner drug exposes malaria parasites increasing risk of artemisinin resistant P. falciparum infections. PZQ plus ACTs has not been tested in patients with schistosomiasis before, thus its effectiveness and safety need to be investigated Objectives To compare the efficacy and tolerability of PZQ- DHP combination versus PZQ alone for treatment of schistosomiasis among school children To determine the PK profile of PZQ given with DHP for schistosomiasis treatment among the school children To determine the PK profile of PZQ given alone as single dose for schistosomiasis treatment among the school children To determine malaria treatment outcome when DHP is given in the presence of PZQ in school children with malaria-schistosomiasis co-infection To determine the influence of pharmacogenetics of PZQ and DHP in schistosomiasis treatment outcome among school children
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Sschistosomiasis
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/01/2017
Actual trial start date 02/01/2017
Anticipated date of last follow up 02/06/2020
Actual Last follow-up date 02/06/2020
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants) 639
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Combination therapy PZQ plus DHP PZQ =40mg/kg DHP = According to malaria treatment guideline PZQ single dose DHP for 3days a combination therapy will be compared to the standard of care(PZQ alone) 298 Active-Treatment of Control Group
Control Group PZQ alone PZQ 40mg/kg single dose single dose this will be compared with the experimental group (PZQ+DHP) 341 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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 Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 5 Year(s) 19 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/05/2016 Muhumbili University of Health and Allied Sciences Etyhical Review Board
Ethics Committee Address
Street address City Postal code Country
United Nation Road Dar es Salaam 11103 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/11/2016 National Institute of Medical Research Ethical commitee
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam 11104 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 1. at 1 month follow up(14-21) 2. at 2 months follow up
Secondary Outcome DHP and PZQ interaction (drug level) Immediately after drug administration blood will be collected over 24hrs for PK studies
Secondary Outcome Pharmacogenetics of PZQ ad DHP for the presence of single nucleotide polymorphisim (SNPs) after drug administration whole blood will be collected at any time point for pharmacogenetic study
Secondary Outcome day 7 piperaquine plasma concetration + malaria treatment outcome using DHP in the presence of PZQ blood samples for piperaquine PK will be taken at day 7 malaria treatment outcome will be assessed at day 1,3,7,14,21 and 28
Secondary Outcome safety + tolerability of the new intervention (adverse events) safety will be assessed at day 1 of the drug administration and at 1month follow up(day 14-21)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Primary schools in llemela District NA Mwanza 1907 Tanzania
Primary schools in Magu NA Mwanza 1907 Tanzania
primary schools in misungwi NA Mwanza 1907 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Sida grant -MUHAS United Nation Road Dar es Salaam 11103 Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Muhumbili University of Health and Allied Sciences United Nation Road Dar es Salaam 11103 Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Dr Safari M Kinung'hi-NIMR Mwanza Mwanza Town Mwanza 1903 Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rajabu Hussein rajabuhussein06@gmail.com +255789044774 United Nation Road
City Postal code Country Position/Affiliation
Dar es Salaam 11103 Thailand Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries Joyce Masalu drp@muhas.ac.tz +255222152489 United Nation Road
City Postal code Country Position/Affiliation
Dar es Salaam 11103 Tanzania Director of Research Publicatiom-MUHAS
Role Name Email Phone Street address
Scientific Enquiries Omary Minzi minziobejayesu@gmail.com +255785892009 United Nation Road
City Postal code Country Position/Affiliation
Dar es Salaam 11103 Tanzania Supervisor
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information