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.: PACTR202211501227743 Date of Approval: 17/11/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of an antimalaria combined with praziquantel for treating Kenya children with intestinal or urogenital bilharzia in Homabay County
Official scientific title Efficacy and safety of Artesunate plus sulfalene/pyrimethamine combined with praziquantel for treatment of children with Schistosoma mansoni or Schistosoma haematobium in Homabay County, Kenya
Brief summary describing the background and objectives of the trial Background: Schistosomiasis is an important but neglected parasitic disease in Kenya. The major control strategy is the reduction of morbidity by chemotherapy using Praziquantel. Evidence from laboratory studies and field trials shows that schistosomes have developed reduced susceptibility to Praziquantel. There is an urgent need to monitor the trends in the efficacy of praziquantel and to search for alternative drugs. Artemisinin derivatives have demonstrated potent antischistosomal activity against the schistosomula (young developing forms) of Schistosomiasis in clinical trials. By contrast, praziquantel is effective against adult worms. The differences in the mechanism of action, suggest that a combination of artemisinin derivatives with praziquantel may offer a potentially effective regimen for curing patients infected with schistosomiasis. Objective: To evaluate the efficacy and safety of artesunate plus sulfalene/pyrimethamine (As+SMP) combined with praziquantel (PZQ) in the treatment of school children infected with either S.mansoni or S. haematobium in Homabay county of western Kenya. Methods: Using an open-label, randomized controlled clinical trial design, 702 children (aged between 6 and 15 years), infected with either S.mansoni or S. haematobium will be randomized (1:1:1) to receive a single treatment dose of praziquantel alone (PZQ) or a single dose of artesunate plus sulfalene/pyrimethamine alone (As+SMP) or a single dose of artesunate plus sulfalene/pyrimethamine combined with a single dose of praziquantel (As+SP plus PZQ). The primary endpoint is efficacy (assessed as cure rate and egg reduction rate, at 6 weeks), while secondary endpoints will include cure rate, egg reduction rate and adverse events by 12 weeks.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 13/01/2014
Actual trial start date 11/09/2014
Anticipated date of last follow up 18/04/2014
Actual Last follow-up date 23/10/2015
Anticipated target sample size (number of participants) 702
Actual target sample size (number of participants) 702
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
Experimental Group Artesunate plus sulfalenepyrimethamine combined with praziquantel 12mg/kg of the Artesunate, once; 40mg/kg of praziquantel, once One day Co-administered Artesunate plus sulfalene/pyrimethamine tablets together with praziquantel tablets according to body weight 234
Experimental Group Artesunate plus sulfalenepyrimethamine 12mg/kg of the Artesunate once one day Oral administration of Artesunate plus sulfalene/pyrimethamine tablet 234
Control Group Praziquantel 40mg/kg, once One day Oral administration 234 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Aged between 6 and 15 years old (confirmed from the date of birth recorded on the school registers), • Study participants appear healthy at enrollment, as assessed by the study clinician • Suffering from S. mansoni or S. haematobium infection • Residing in Homabay county • Able to take oral treatment, • Respective parent/ guardian gives informed consent for the child to participate in the study • Child assent to participate in study • Weighing more than 50 kg, • Pregnant or lactating at the time of the study, • Presence of infection with Plasmodium falciparum or other Plasmodium spp. • Presence of severe illness, such as cerebral cysticercosis, • Signs of severe malnutrition • Hypersensitivity to Artesunates, sulfonamides or praziquantel. • Use of another anti-malaria or anti-schistosomal drug during the study, or within 28 days before the administration of the study treatment. 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 04/11/2013 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 Efficacy, assessed as Cure rate 6 weeks
Secondary Outcome egg reduction rate by week 6 after starting treatment 6 weeks
Secondary Outcome mean change in haemoglobin 6 weeks
Secondary Outcome Adverse events 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rachuonyo division Kisumu-Homabay Road Homabay 40300 Kenya
Migori County Homabay-Migori road Migori 40400 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
Dr Erick Muok P. O. Box 1578 Kisumu 40100 Kenya
Dr Vincent Were P. O. Box 1578 Kisumu 40100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Charles Obonyo cobonyo65@yahoo.com +254724993118 P.O. Box 1578
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Chief Research Officer
Role Name Email Phone Street address
Public Enquiries Erick Muok Emuok@kemri.go.ke +254721757340 Kisumu-Busia Road
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Deputy Director
Role Name Email Phone Street address
Scientific Enquiries Charles Obonyo cobonyo65@yahoo.com +254724993118 P.O. Box 1578
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 that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,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