search
Back to results

Schistosoma Haematobium Infections and Praziquantel

Primary Purpose

Schistosomiasis

Status
Completed
Phase
Phase 3
Locations
Sudan
Study Type
Interventional
Intervention
praziquantel
Sponsored by
University of Khartoum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schistosomiasis focused on measuring Schistosoma haematobium, schoolchildren, Central Sudan, Praziquantel

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • School children

Exclusion Criteria:

  • Taking praziquantel

Sites / Locations

  • Al Salamania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Praziguantel

Arm Description

tablet single dose

Outcomes

Primary Outcome Measures

cure rate
The reduction of the prevalence and intensity of S.haematobium infection following a single dose of praziquantel40mg/kg

Secondary Outcome Measures

reduction in the intensity of infection by
will a single dose of PZQ significantly reduced intensity of infection of S. haematobium infection 1 year after treatment

Full Information

First Posted
March 16, 2012
Last Updated
January 16, 2013
Sponsor
University of Khartoum
Collaborators
Hikma Pharmaceuticals LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT01558336
Brief Title
Schistosoma Haematobium Infections and Praziquantel
Official Title
Schistosoma Haematobium Infections Among Schoolchildren in Central Sudan One Year After Treatment With Praziquantel
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Khartoum
Collaborators
Hikma Pharmaceuticals LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schistosomiasis
Keywords
Schistosoma haematobium, schoolchildren, Central Sudan, Praziquantel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
520 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Praziguantel
Arm Type
Experimental
Arm Description
tablet single dose
Intervention Type
Drug
Intervention Name(s)
praziquantel
Intervention Description
praziquantel 40 mg/kg oral tablets
Primary Outcome Measure Information:
Title
cure rate
Description
The reduction of the prevalence and intensity of S.haematobium infection following a single dose of praziquantel40mg/kg
Time Frame
one year
Secondary Outcome Measure Information:
Title
reduction in the intensity of infection by
Description
will a single dose of PZQ significantly reduced intensity of infection of S. haematobium infection 1 year after treatment
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: School children Exclusion Criteria: Taking praziquantel
Facility Information:
Facility Name
Al Salamania
City
Al Salamania
State/Province
Nile
Country
Sudan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21729382
Citation
Ahmed AM, El Tash LA, Mohamed EY, Adam I. High levels of Schistosoma mansoni infections among schoolchildren in central Sudan one year after treatment with praziquantel. J Helminthol. 2012 Jun;86(2):228-32. doi: 10.1017/S0022149X11000290. Epub 2011 Jun 8.
Results Reference
result

Learn more about this trial

Schistosoma Haematobium Infections and Praziquantel

We'll reach out to this number within 24 hrs