Randomised controlled trial of two different dosing regimens of praziquantel anti-bilharzia drug
| ISRCTN | ISRCTN18009264 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18009264 |
| Secondary identifying numbers | PZQ 17 |
- Submission date
- 08/08/2019
- Registration date
- 28/08/2019
- Last edited
- 28/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Faculty Of Medicine
University of Khartoum
Khartoum
PO Box 102
Sudan
| Phone | +249 (0)123001487 |
|---|---|
| o.elshazali@uofk.edu |
Study information
| Study design | Single-centre blinded randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | School |
| Study type | Treatment |
| Scientific title | Randomised controlled trial of two different dosing regimens of praziquantel for the treatment of Schistosoma haematobium in children |
| Study acronym | PZQRCT |
| Study objectives | The higher dose of praziquantel is better than the standard dose in treating Schistosoma haematobium in children. |
| Ethics approval(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 15/01/2017 |
| Completion date | 01/04/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 14 Years |
| Sex | 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 |
| Key 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 |
| Key exclusion criteria | 1. Refused to participate in the study 2. Age less than 6 years or more than 14 years |
| Date of first enrolment | 18/01/2017 |
| Date of final enrolment | 01/02/2017 |
Locations
Countries of recruitment
- Sudan
Study participating centre
Khartoum North
0000
Sudan
Sponsor information
University/education
Faculty of Laboratory Science
Buri
Khartoum
0000
Sudan
| Phone | +249 (0)999990150 |
|---|---|
| drabubakrhim@gmail.com | |
"ROR" |
https://ror.org/01x7yyx87 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/10/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers will publish the final results of the study in the next few weeks. |
| IPD sharing plan | 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. |
Editorial Notes
22/08/2019: Trial's existence confirmed by ethics committee.
