Schistosoma Haematobium Infections and Praziquantel

• Sponsor: University of Khartoum (Other)
• Overall Status: Completed
• CT.gov ID: NCT01558336
• Collaborator: Hikma Pharmaceuticals LLC (Industry)
• Enrollment: 520
• Location: 1
• Arm: 1
• Duration (Months): 49
• Patients Per Site Per Month: 10.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schistosomiasis	Drug: praziquantel	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 520 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Schistosoma Haematobium Infections Among Schoolchildren in Central Sudan One Year After Treatment With Praziquantel
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. cure rate [one year]

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

Secondary Outcome Measures

1. reduction in the intensity of infection by [one year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• School children

Exclusion Criteria:

• Taking praziquantel

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al Salamania	Al Salamania	Nile	Sudan

Sponsors and Collaborators

• University of Khartoum
• Hikma Pharmaceuticals LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ishag Adam, Professor, University of Khartoum
• ClinicalTrials.gov Identifier: NCT01558336
• Other Study ID Numbers: Schistosmiasis
• First Posted: Mar 20, 2012
• Last Update Posted: Jan 17, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Ishag Adam, Professor, University of Khartoum: Schistosoma haematobium; schoolchildren; Central Sudan; Praziquantel
• Additional relevant MeSH terms: Schistosomiasis; Schistosomiasis haematobia; Praziquantel

Study Results

No Results Posted as of Jan 17, 2013