Efficacy and safety of increased dosage of praziquantel in treatment of schistosomiasis
| ISRCTN | ISRCTN29273316 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29273316 |
| ClinicalTrials.gov number | NCT00403611 |
| Secondary identifying numbers | A30008: Tanzania (Master) (A20764: Brazil; A20805: Philippines; A30000: Mauritania) |
- 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
Scientific
World Health Organization
20, Avenue Appia
Geneva-27
CH-1211
Switzerland
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 18/02/2004 |
| Completion date | 18/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 19 Years |
| Sex | Both |
| Target number of participants | 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
CH-1211
Switzerland
Sponsor information
UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
Research organisation
Research organisation
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
| Website | http://www.who.int |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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
