Plain English Summary
Background and study aims
The aim of this study is to compare the effectiveness and side effects of two different doses of the drug praziquantel for the treatment of Schistosoma haematobium parasite infection (bilharzia) in children.
Who can participate?
Primary school children in the two villages of Elkeriab and Tayba Elkababish , Khartoum State, who are affected with urinary bilharzia
What does the study involve?
Children randomly allocated to one of two different doses of praziquantel (the standard drug for bilharzia). Schistosoma eggs, blood in the urine and egg viability are measured by urine testing weekly for six weeks.
What are the possible benefits and risks of participating?
Praziquantel has been used for more than 30 years, with a good track record using the same doses used in this study. The children will benefit by getting treated for bilharzia with an effective and safe medicine. This drug can have minor side effects such as nausea, vomiting and skin rash, but side effects are not common.
Where is the study run from?
The study will be run and conducted in the villages of Elkeriab and Tayba Elkababish, East Nile Locality, Khartoum State, Sudan.
When is the study starting and how long is it expected to run for?
January 2017 to April 2017
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Abu Bakr Ibrahim
drabubakrhim@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Osama Elshazali
ORCID ID
Contact details
Faculty Of Medicine
University of Khartoum
Khartoum
PO Box 102
Sudan
+249 (0)123001487
o.elshazali@uofk.edu
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
PZQ 17
Study information
Scientific title
Randomised controlled trial of two different dosing regimens of praziquantel for the treatment of Schistosoma haematobium in children
Acronym
PZQRCT
Study hypothesis
The higher dose of praziquantel is better than the standard dose in treating Schistosoma haematobium in children.
Ethics approval
Approved 07/01/2017, Ethics Committee of Khartoum State Ministry of Health, Sudan (Dr Mona Fath Alrahman Omer,
Directorate of the research Department, Khartoum Ministry of Health (KMOH); Tel +249 (0)183760140; Email: ibtikar.Kmoh@gmail.com)
Study design
Single-centre blinded randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Schools
Trial type
Treatment
Patient information sheet
Condition
Urinary schistosomiasis in children
Intervention
Randomisation was computer-generated, allocation concealment using opaque brown envelopes. The children, their parents and the research assistant checking for the outcome were all blinded to the group allocation.
Two different dosing regimens of praziquantel were compared for the treatment of urinary schistosomiasis in children: a dose of 40 mg/kg vs 60 mg/kg. The 40 mg/kg was given in two equal doses four hours apart and the 60 mg/kg was divided into three equal doses four hours apart. The doses were administered by a doctor.
The patients were followed up weekly for a total duration of 6 weeks post intervention.
Intervention type
Drug
Phase
Not Applicable
Drug names
Praziquantel
Primary outcome measure
Schistosoma ova, haematuria and ova viability measured using urine test weekly for six weeks
Secondary outcome measures
Side effects of praziquantel assessed using patient interviews at week one
Overall trial start date
15/01/2017
Overall trial end date
01/04/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. School age children (6-14 years of age)
2. Male and females
3. Positive urine test for Schistosoma ova
4. Lives in specific locality of Elkeriab and Tayba Elkababish, Khartoum State, Sudan
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
The population of the study was all the primary school children in the two primary schools (Elkeriab and Tayba Elkababish ). The total number of school children was 1205 children, 105 students tested positive for urinary schistosomiasis, so were included in the trial.
Total final enrolment
105
Participant exclusion criteria
1. Refused to participate in the study
2. Age less than 6 years or more than 14 years
Recruitment start date
18/01/2017
Recruitment end date
01/02/2017
Locations
Countries of recruitment
Sudan
Trial participating centre
Elkeriab and Tayba Elkabaish primary schools
Elkeriab Village, East Nile Locality
Khartoum North
0000
Sudan
Sponsor information
Organisation
The National Ribat University
Sponsor details
Faculty of Laboratory Science
Buri
Khartoum
0000
Sudan
+249 (0)999990150
drabubakrhim@gmail.com
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The researchers will publish the final results of the study in the next few weeks.
IPD sharing statement
Please contact Prof Abu Bakr Ibrahim (drabubakrhim@gmail.com) for access to the datasets, the data will be available from September 2019 for three months, the researchers have obtained consent from participants that data may be shared for research and educational purposes only.
Intention to publish date
01/10/2019
Participant level data
Available on request
Basic results (scientific)
Publication list