Efficacy and safety of increased dosage of praziquantel in treatment of schistosomiasis

ISRCTN	ISRCTN29273316
DOI	https://doi.org/10.1186/ISRCTN29273316
ClinicalTrials.gov (NCT)	NCT00403611
Protocol serial number	A30008: Tanzania (Master) (A20764: Brazil; A20805: Philippines; A30000: Mauritania)
Sponsor	UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
Funder	United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)

Submission date: 07/04/2005
Registration date: 07/06/2005
Last edited: 28/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr P Olliaro
Scientific

World Health Organization
20, Avenue Appia
Geneva-27
CH-1211
Switzerland

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Efficacy and safety of increased dosage of praziquantel in treatment of schistosomiasis
Study objectives	The primary objective of this project is to evaluate the efficacy and safety of praziquantel 60 mg/kg in the treatment of schistosomiasis, as compared to the standard 40 mg/kg therapy in a representative community from a highly endemic area of schistosomiasis in Northeastern Brazil. Cure rates, reduction in egg counts and proportions of reported side-effects in children at the 10 - 19 years age-range with at least 100 eggs per gram of faeces will be compared between regimens, aiming to evaluate the superiority of 60 mg/kg over the 40 mg/kg dose currently recommended by the World Health Organization (WHO). Reinfection rates will also be evaluated aiming to improve transmission control within the local health system, including re-treatment combined with auxiliary control measures. Features related to the clinical, nutritional and immunological status of the patients prior to treatment will also be investigated in association with the outcome of praziquantel treatment.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Schistosomiasis
Intervention	Praziquantel 60 mg/kg as single dose compared to standard 40 mg/kg as single dose.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Praziquantel
Primary outcome measure(s)	1. Cure rate and egg reduction rate at 21 days after treatment 2. Reinfection rate and egg reduction rate at six and twelve months after treatment
Key secondary outcome measure(s)	1. Occurrence of the following symptoms following praziquantel administration: 1.1. Abdominal pain 1.2. Diarrhoea 1.3. Vomiting 1.4. Nausea 1.5. Drowsiness 1.6. General malaise 1.7. Oedema 1.8. Skin rash 1.9. Urticaria 1.10. Myalgia 1.11. Heartburn 1.12. Fever 1.13. Dizziness and headache 2. Weight (kg) and height (m) measured at day 0, 6 months and 12 months follow-up visits 3. Presence/absence of periportal fibrosis and liver or spleen enlargement at day 0, 6 months and 12 months follow-up visits 4. Factors associated with cure/failure at day 21 evaluation: 4.1. Haematological: haemoglobin/haematocrit, leukocytes count, lymphocytes and eosinophyles count 4.2. Biochemistry: liver function will be evaluated by serum bilirubin, alkaline phosphatase, aspartate aminotransferase, and alanine aminotransferase levels 4.3. Immunological: titres of anti-soluble egg antigen (anti-SEA) and anti-SWAB antibodies 5. Periportal fibrosis and liver/spleen enlargement
Completion date	18/02/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	10 Years
Upper age limit	19 Years
Sex	All
Target sample size at registration	182
Key inclusion criteria	1. Subjects 10 - 19 years old 2. Harbouring at least 100 eggs per gram of faeces (epg) 3. Able and willing to follow-up and provide written informed consent
Key exclusion criteria	1. Pregnancy or lactation 2. Acute or chronic severe disease including hepato-splenic schistosomiasis 3. Use of praziquantel in the last 30 days 4. Known hypersensitivity associated with praziquantel 5. Current use of other medication that may affect the result of present trial e.g. antibiotics and corticosteroids Withdrawal criteria: Serious adverse event, intake of any other anti-schistosomal medication during the trial
Date of first enrolment	18/02/2004
Date of final enrolment	18/02/2006

Locations

Countries of recruitment

Brazil
Mauritania
Philippines
Switzerland
Tanzania

Study participating centre

World Health Organization

Geneva-27
CH-1211
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2011	28/01/2019	Yes	No

Editorial Notes

28/01/2019: Publication reference added