Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00403611
Protocol/serial number
A30008: Tanzania (Master) (A20764: Brazil; A20805: Philippines; A30000: Mauritania)
Study information
Scientific title
Efficacy and safety of increased dosage of praziquantel in treatment of schistosomiasis
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Praziquantel
Primary outcome measure
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
Secondary outcome measures
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
Overall trial start date
18/02/2004
Overall trial end date
18/02/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
182
Participant 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
Recruitment start date
18/02/2004
Recruitment end date
18/02/2006
Locations
Countries of recruitment
Brazil, Mauritania, Philippines, Tanzania
Trial participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
Sponsor details
20
Avenue Appia
Geneva -27
CH 1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
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)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in https://www.ncbi.nlm.nih.gov/pubmed/21695161 (added 28/01/2019)