Schistosoma Haematobium Infections and Praziquantel

January 16, 2013 updated by: Ishag Adam, University of Khartoum

Schistosoma Haematobium Infections Among Schoolchildren in Central Sudan One Year After Treatment With Praziquantel

The purpose of this study is to evaluate the impact of praziquantel for the treatment of Schistosoma haematobium infection among schoolchildren in Al Salamania in Central Sudan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A longitudinal study will be conducted to evaluate the impact of praziquantel for the treatment of Schistosoma haematobium infection among schoolchildren in Al Salamania in Central Sudan. A cohort of schoolchildren (6-15 years of age) was investigated before and 1 year after treatment with a single dose of praziquantel 40mg/kg.

Study Type

Interventional

Enrollment (Actual)

520

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sudan
    • Nile
      • Al Salamania, Nile, Sudan
        • Al Salamania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • School children

Exclusion Criteria:

  • Taking praziquantel

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Praziguantel
tablet single dose
Drug: praziquantel
praziquantel 40 mg/kg oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cure rate
Time Frame: one year
The reduction of the prevalence and intensity of S.haematobium infection following a single dose of praziquantel40mg/kg
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction in the intensity of infection by
Time Frame: one year
will a single dose of PZQ significantly reduced intensity of infection of S. haematobium infection 1 year after treatment
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Khartoum

Collaborators

Hikma Pharmaceuticals LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (Estimate)

March 20, 2012

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Schistosmiasis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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