Evaluation of Praziquantel Dosage for Treatment of Schistosomiasis in Brazil

NCT00403611 | Completed Phase 4

• 1 other identifier: A20764
• Study Type: interventional
• Target: 196
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 y 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 40mg/kg dose currently recommended by the 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.

Conditions

Schistosomiasis Mansoni

Outcome Measures

Primary Outcomes (1)

• Cure rate and egg reduction rate at twenty-one days after treatment

  21 days

Secondary Outcomes (8)

• Occurrence of the following symptoms following praziquantel administration: abdominal pain, diarrhea, vomiting, nausea, drowsiness, general malaise, edema, skin rash, urticaria, myalgia, heartburn, fever, dizziness and headache.

  21 days

• Weight (Kg) and height (m) measured at Day 0, 6 months and 12 months follow-up visits.

  12 months

• Presence/absence of periportal fibrosis and liver or spleen enlargement at Day 0, 6 months and 12 months follow-up visits.

  12 months

• Factors associated with cure/failure at Day 21 evaluation:

  21 days

• Haematological: Haemoglobin/ Hematocrit, leukocytes count, lymphocytes and eosinophiles count.

  0 days

Study Arms (2)

Praziquantel 40mg/kg

ACTIVE COMPARATOR

Praziquantel (Distocide) 40mg/kg single oral dose

Drug: Praziquantel 40 mg/kg

Praziquantel 60mg/kg

EXPERIMENTAL

Praziquantel (Distocide) 60mg/kg single oral dose

Drug: Praziquantel 60 mg/kg

Interventions

Praziquantel 60 mg/kg DRUG

Praziquantel (Distocide) 60 mg/kg single oral dose

Also known as: Distocide

Praziquantel 60mg/kg

Praziquantel 40 mg/kg DRUG

Praziquantel (Distocide) 40 mg/kg single oral dose

Also known as: Distocide

Praziquantel 40mg/kg

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Persons with 10-19 years of age harbouring at least 100 epg who are able and willing to follow-up and provide a written informed consent will participate in the study

You may not qualify if:

• Pregnancy or lactation
• Acute or chronic severe diseases including hepato-splenic schistosomiasis
• Use of praziquantel in the last 30 days
• Known hypersensitivity associated with praziquantel
• Current use of other medication that may affect the results of the present trial, such as antibiotics and corticosteroids, and any medical condition that on the judgement of the physician makes subject participation impossible.

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead
• World Health Organization: collaborator
• Universidade Federal de Pernambuco: collaborator

MeSH Terms

Conditions

Schistosomiasis mansoni

Interventions

Praziquantel

Condition Hierarchy (Ancestors)

Schistosomiasis; Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Otavio S Pieri, PhD

  Fundação Oswaldo Cruz

  PRINCIPAL INVESTIGATOR

• Ana Lucia C Domingues, MD

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: November 24, 2006
• First Posted: November 27, 2006
• Study Start: March 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: May 1, 2008
• Last Updated: June 17, 2015

Record last verified: 2015-06