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.: PACTR202008871179105 Date of Approval: 07/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Praziquantel therapy for Schistosoma manson infection in preschool-aged children
Official scientific title Optimization of praziquantel therapy for Schistosoma mansoni infection in preschool-aged children in Ethiopia: PrazOpt
Brief summary describing the background and objectives of the trial The occurrence of schistosomiasis within African infants and preschool-aged children (PSAC) has been much better documented in recent years, revealing an important burden of disease previously overlooked. The use of praziquantel standard dose of 40 mg/kg to treat PSAC has been initiated because of the experience in SAC and adults. A single arm study will be used to assess curative rate and safety of single dose praziquantel (40 mg/kg) in S. mansoni infected PSAC using longitudinal study design. This clinical research will also study the pharmacokinetics and pharmacogenetics of praziquantel in this population.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) PrazOpt
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Schistosomiasis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/09/2020
Actual trial start date
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 218
Actual target sample size (number of participants)
Recruitment status Withdrawn
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 Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Praziquantel 40 mg/kg single dose Single dose Praziquantel 40 mg/kg single dose will be administered to participants after diagnosed positive for Schistosoma mansoni eggs 218
Control Group Praziquantel 40 mg/kg single dose Single dose Praziquantel 40 mg/kg single dose will be administered to preschool-aged children diagnosed positive for Schistosoma mansoni eggs 218 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- 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 - 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. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 4 Month(s) 7 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 08/03/2020 National Research Ethics Review Committee hosted by Ministry of Science and Education
Ethics Committee Address
Street address City Postal code Country
Ring Road Addis Ababa 2376 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cure rate 28 days after treatment
Secondary Outcome - Egg reduction rate - Safety and tolerability (adverse events) - Estimates of pharmacokinetic parameters (AUC, Cmax, Tmax, t1/2, Tlag) - Correlates of curative outcome 28 days after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bushulo Health Center Hawassa Lake Shore Hawassa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Tygerberg 7505 Cape Town South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CDT Africa Addis Ababa University Zambia street Addis Ababa Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Karolinska Institutet 171 77 Stockholm Stockholm Sweden
Hawassa University na Hawassa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Solomon Mequanente Abay solomon.mequanente@aau.edu.et +251941222169 Zambia street
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Addis Ababa University
Role Name Email Phone Street address
Public Enquiries Abebaw Fekadu Wassie abebaw.fekadu@aau.edu.et +251912894975 Zambia street
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Head of CDT Africa of Addis Ababa University
Role Name Email Phone Street address
Scientific Enquiries Eyasu Makonnen Eshetu eyasumakonnen@yahoo.com +251911247556 Zambia street
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Deputy Head of CDT Africa of Addis Ababa University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We have the intent to share IPD- individual deidentified participant data and related documents (e.g., study protocol, consent form) Informed Consent Form,Study Protocol 2 years Controlled type
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information