Condition category
Infections and Infestations
Date applied
08/08/2019
Date assigned
28/08/2019
Last edited
28/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

22/08/2019: Trial's existence confirmed by ethics committee.