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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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11 February 2019 |
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Main ID: |
ISRCTN29273316 |
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Date of registration:
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07/06/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and safety of increased dosage of praziquantel in treatment of schistosomiasis
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Scientific title:
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Efficacy and safety of increased dosage of praziquantel in treatment of schistosomiasis |
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Date of first enrolment:
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18/02/2004 |
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Target sample size:
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182 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN29273316 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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Brazil
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Mauritania
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Philippines
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Tanzania
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Contacts
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Name:
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P
Olliaro |
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Address:
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World Health Organization
20, Avenue Appia
CH-1211
Geneva-27
Switzerland |
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Telephone:
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Email:
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Schistosomiasis
Infections and Infestations
Schistosomiasis
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Intervention(s)
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Praziquantel 60 mg/kg as single dose compared to standard 40 mg/kg as single dose.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Secondary ID(s)
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NCT00403611
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A30008: Tanzania (Master) (A20764: Brazil; A20805: Philippines; A30000: Mauritania)
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Source(s) of Monetary Support
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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)
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Ethics review
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Status:
Approval date:
Contact:
Not provided at time of registration
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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18/02/2006 |
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URL:
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