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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29273316

Enrollment

182

Registered

2005-06-07

Start date

2004-02-18

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schistosomiasis Infections and Infestations Schistosomiasis

Interventions

Praziquantel 60 mg/kg as single dose compared to standard 40 mg/kg as single dose.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Brazil, Mauritania, Philippines, Tanzania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026