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NCT01558336 Clinical Trial

Schistosoma Haematobium Infections and Praziquantel

Schistosomiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01558336
Other study ID # Schistosmiasis
Secondary ID
Status Completed
Phase Phase 3
First received March 16, 2012
Last updated January 16, 2013
Start date August 2008
Est. completion date September 2012

Study information
Verified date January 2013
Source University of Khartoum
Contact n/a
Is FDA regulated No
Health authority Sudan: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 520
Est. completion date September 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 15 Years
Eligibility Inclusion Criteria:

- School children

Exclusion Criteria:

- Taking praziquantel

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• praziquantel
praziquantel 40 mg/kg oral tablets

Locations
Country Name City State
Sudan Al Salamania Al Salamania Nile

Sponsors (2)
Lead Sponsor Collaborator
University of Khartoum Hikma

Country where clinical trial is conducted

Sudan, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary cure rate The reduction of the prevalence and intensity of S.haematobium infection following a single dose of praziquantel40mg/kg one year No
Secondary 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 one year No
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