Condition category
Infections and Infestations
Date applied
07/04/2005
Date assigned
07/06/2005
Last edited
11/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr P Olliaro

ORCID ID

Contact details

World Health Organization
20
Avenue Appia
Geneva-27
CH-1211
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00403611

Protocol/serial number

A30008: Tanzania (Master) (A20764: Brazil; A20805: Philippines; A30000: Mauritania)

Study information

Scientific title

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 measures

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

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

http://www.who.int

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes