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.: PACTR202001919442161 Date of Approval: 06/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of Praziquantel with antimalarial drug combinations in the treatment of children with bilharzia in Kirinyaga county, Kenya
Official scientific title Efficacy and safety of Praziquantel alone or in combination with Artemisinin-based combinations in the treatment of children with Schistosoma mansoni in Mwea, Kirinyaga County, Kenya
Brief summary describing the background and objectives of the trial Schistosomiasis remains an important but neglected parasitic disease in sub-Saharan Africa, including Kenya. The major control strategy is the reduction of morbidity by preventive chemotherapy using Praziquantel (PZQ). However, there is evidence from laboratory studies and field trials showing that schistosomes have developed reduced susceptibility to Praziquantel. These observations call for an urgent need to develop other drugs to replace or complement the use of praziquantel in the treatment of schistosomiasis. Artemisinin derivatives (artesunate, artemether) are effective against the schistomulae (young developing forms) of S. mansoni or S. haematobium, while praziquantel is effective against the adult worms. These differences in the mechanism of action, suggests that a combination of artemisinin derivatives with praziquantel may be synergistic, offering a more effective regimen for interrupting the transmission of schistosomiasis. It is unclear whether combining an artemisinin-based combination (ACT) with praziquantel is more effective and safe compared with praziquantel alone for treating patients infected with schistosomiasis. Objective: The proposed study aims to evaluate: (a) the interaction between schistosomiasis and malaria; and (b) the additional benefit of adding an artemisinin-based combination (ACT) to a single dose of praziquantel in the treatment of children infected with S.mansoni in Mwea area, Kirinyaga County, Kenya.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SCHISTOACT
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 08/01/2018
Actual trial start date 10/09/2018
Anticipated date of last follow up 15/03/2019
Actual Last follow-up date 01/04/2019
Anticipated target sample size (number of participants) 540
Actual target sample size (number of participants) 540
Recruitment status Completed
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 randomization using a randomization 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
Control Group Praziquantel 40mg/kg once one day Oral Praziquantel tablets (600mg) 108 Active-Treatment of Control Group
Experimental Group Artesunate plus sulfalene with pyrimethamine Plus praziquantel Artesunate +sulfalene +pyrimethamine (4mg/kg of artesunate) given once daily Praziquantel (40mg/kg) once Three days (Artesunate plus sulfalene with pyrimethamine) One day (praziquantel) oral Fixed dose combination (Coarinate Junior) Oral praziquantel tablet (600mg) 108
Experimental Group Artesunate plus Amodiaquine plus praziquantel Artesunate plus aamodiaquine (4mg/kg of artesunate) once daily Praziquantel (40mg/kg) once Three days (Artesunate plus amodiaquine) One day (praziquantel) Oral Artesunate plus amoodiaquine Oral Praziquantel 108
Experimental Group Artesunate plus mefloquine plus praziquantel Artesunate plus mefloquine (1 tablet for those weighing 15 to 30kg, 2 tablets for those weighin above 30kg) once daily Praziquantel (40mg/kg) once 3 days (Artesunate plus mefloquine) One day (praziquantel) Oral Artesunate plus mefloquine tablet Oral praziquantel tablet 108
Experimental Group Dihydroartemisinin piperaquine plus praziquantel Dihydroartemisinin piperaquine (1.5 tablets for 15 to 24.9kg, 2 tablets for 25 to 34.9kg and 3 tablets for above 35kg) once daily Praziquantel (40mg/kg) once 3 days (Dihydroartemisinin piperaquine) 1 day (Praziquantel) Oral Dihydroartemisinin piperaquine One Praziquantel 108
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For participants to be enrolled in the study they have to meet ALL of the following criteria: • Aged between 6 and 15 years old (confirmed from the date of birth recorded on the school registers), • Testing positive for S. mansoni infection (confirmed by presence of eggs in stool). • Residing in Mwea East and Mwea West, Kirinyaga County • Able to take oral treatment • Respective parent/ guardian provides written informed consent for the child to participate in the study • Child provides written assent to participate in the study Potential participants will be excluded for any of the following reasons: • Weighing more than 50 kg, • Haemoglobin level ≤ 5.0g/dL • Signs of severe malnutrition (defined as severe wasting or MUAC <12cm) • Hypersensitivity to Artesunates, sulfonamides or praziquantel. • Use of an anti-malaria or anti-schistosomial drug within 28 days before enrollment in the study. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 6 Year(s) 15 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 12/03/2018 KEMRI Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Mbagathi road NAIROBI 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cure rate 28 days
Primary Outcome Egg reduction rate 28 days
Secondary Outcome Proportion cured 3 months
Secondary Outcome Proportion cured 6 months
Secondary Outcome Adverse events 28 days
Secondary Outcome Egg reduction rate 3 months
Secondary Outcome Egg reduction rate 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mwea area Nairobi-Mwea road Kerugoya 10300 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Kenya Government Mbagathi road Nairobi 00200 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kenya Medical Research Institute Mbagathi road Nairobi 00200 Kenya Research Institute
COLLABORATORS
Name Street address City Postal code Country
Erick M.O. Muok Kisumu-Busia road Kiisumu 40100 Kenya
Vincent O. Were Kisumu-Busia road Kisumu 40100 Kenya
Peter Wamae Kisumu-Busia road Kisumu 40100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Charles Obonyo cobonyo65@yahoo.com +254724993118 Kiisumu-Busia road
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Chief Research Officer
Role Name Email Phone Street address
Public Enquiries Charles Obonyo cobonyo65@yahoo.com +254724993118 Kisumu-Busia road
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Chief Research Officer
Role Name Email Phone Street address
Scientific Enquiries Charles Obonyo cobonyo65@yahoo.com +254724993118 Kisumu-Busia road
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Chief Research Officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data collected during the trial. after deidentification Clinical Study Report,Informed Consent Form,Study Protocol Beginning 3 months and ending 5 years after publication of the article. Researchers who provide a methodologically sound proposal
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 09/12/2019 Correction to include ages between 6 yrs and 15 years Adolescent: 13 Year-18 Year Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 18/12/2019 Corrected the sample size Control Group, Praziquantel, 40mg/kg once, one day, Oral Praziquantel tablets (600mg), 105, Active-Treatment of Control Group Control Group, Praziquantel, 40mg/kg once, one day, Oral Praziquantel tablets (600mg), 108, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 18/12/2019 Corrected the sample size Added the dose for praziquantel Experimental Group, Artesunate plus sulfalene with pyrimethamine Plus praziquantel, Artesunate +sulfalene +pyrimethamine (4mg/kg of artesunate) given once daily Praziquantel once, Three days (Artesunate plus sulfalene with pyrimethamine) One day (praziquantel), oral Fixed dose combination (Coarinate Junior) Oral praziquantel tablet (600mg), 105, Experimental Group, Artesunate plus sulfalene with pyrimethamine Plus praziquantel, Artesunate +sulfalene +pyrimethamine (4mg/kg of artesunate) given once daily Praziquantel (40mg/kg) once, Three days (Artesunate plus sulfalene with pyrimethamine) One day (praziquantel), oral Fixed dose combination (Coarinate Junior) Oral praziquantel tablet (600mg), 108,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 18/12/2019 corrected the sample size Experimental Group, Artesunate plus Amodiaquine plus praziquantel, Artesunate plus aamodiaquine (4mg/kg of artesunate) once daily Praziquantel (40mg/kg) once, Three days (Artesunate plus amodiaquine) One day (praziquantel), Oral Artesunate plus amoodiaquine Oral Praziquantel, 105, Experimental Group, Artesunate plus Amodiaquine plus praziquantel, Artesunate plus aamodiaquine (4mg/kg of artesunate) once daily Praziquantel (40mg/kg) once, Three days (Artesunate plus amodiaquine) One day (praziquantel), Oral Artesunate plus amoodiaquine Oral Praziquantel, 108,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 18/12/2019 corrected the sample size Experimental Group, Artesunate plus mefloquine plus praziquantel, Artesunate plus mefloquine (1 tablet for those weighing 15 to 30kg, 2 tablets for those weighin above 30kg) once daily Praziquantel (40mg/kg) once, 3 days (Artesunate plus mefloquine) One day (praziquantel) , Oral Artesunate plus mefloquine tablet Oral praziquantel tablet, 105, Experimental Group, Artesunate plus mefloquine plus praziquantel, Artesunate plus mefloquine (1 tablet for those weighing 15 to 30kg, 2 tablets for those weighin above 30kg) once daily Praziquantel (40mg/kg) once, 3 days (Artesunate plus mefloquine) One day (praziquantel) , Oral Artesunate plus mefloquine tablet Oral praziquantel tablet, 108,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 18/12/2019 corrected the sample size Experimental Group, Dihydroartemisinin piperaquine plus praziquantel, Dihydroartemisinin piperaquine (1.5 tablets for 15 to 24.9kg, 2 tablets for 25 to 34.9kg and 3 tablets for above 35kg) once daily Praziquantel (40mg/kg) once, 3 days (Dihydroartemisinin piperaquine) 1 day (Praziquantel), Oral Dihydroartemisinin piperaquine One Praziquantel, 105, Experimental Group, Dihydroartemisinin piperaquine plus praziquantel, Dihydroartemisinin piperaquine (1.5 tablets for 15 to 24.9kg, 2 tablets for 25 to 34.9kg and 3 tablets for above 35kg) once daily Praziquantel (40mg/kg) once, 3 days (Dihydroartemisinin piperaquine) 1 day (Praziquantel), Oral Dihydroartemisinin piperaquine One Praziquantel, 108,
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 18/12/2019 Entered the mandatory details required. Undecided Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 18/12/2019 Entered the mandatory details required. Individual participant data collected during the trial. after deidentification
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 18/12/2019 Entered the required mandatory information. Beginning 3 months and ending 5 years after publication of the article.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 18/12/2019 Entered the required mandatory information. Researchers who provide a methodologically sound proposal
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 18/12/2019 Entered the required mandatory information. Study Protocol, Informed Consent Form, Clinical Study Report