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Efficacy and safety of increased dosage of praziquantel in treatment of schistosomiasis
ISRCTN ISRCTN29273316
DOI 10.1186/ISRCTN29273316
ClinicalTrials.gov identifier NCT00403611
EudraCT number
Public title Efficacy and safety of increased dosage of praziquantel in treatment of schistosomiasis
Scientific title
Acronym N/A
Serial number at source A30008: Tanzania (Master) (A20764: Brazil; A20805: Philippines; A30000: Mauritania)
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.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Brazil, Mauritania, Philippines, Tanzania
Disease/condition/study domain Schistosomiasis
Participants - 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
Participants - 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
Anticipated start date 18/02/2004
Anticipated end date 18/02/2006
Status of trial Completed
Patient information material
Target number of participants 182
Interventions Praziquantel 60 mg/kg as single dose compared to standard 40 mg/kg as single dose.
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
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
Sources of funding 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)
Trial website
Publications
Contact name Dr  P  Olliaro
  Address World Health Organization
20, Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH-1211
  Country Switzerland
Sponsor UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
  Address 20, Avenue Appia
  City/town Geneva -27
  Zip/Postcode CH 1211
  Country Switzerland
  Sponsor website: http://www.who.int
Date applied 07/04/2005
Last edited 11/08/2008
Date ISRCTN assigned 07/06/2005
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