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Schistosoma Haematobium Infections and Praziquantel

This study has been completed.
Sponsor:
Collaborator:
Hikma
Information provided by (Responsible Party):
Ishag Adam, University of Khartoum
ClinicalTrials.gov Identifier:
NCT01558336
First received: March 16, 2012
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Schistosomiasis
 Drug: praziquantel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Schistosoma Haematobium Infections Among Schoolchildren in Central Sudan One Year After Treatment With Praziquantel

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Khartoum:

Primary Outcome Measures:
  • cure rate [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]
    will a single dose of PZQ significantly reduced intensity of infection of S. haematobium infection 1 year after treatment


Enrollment: 520
Study Start Date: August 2008
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Praziguantel
tablet single dose
 Drug: praziquantel
praziquantel 40 mg/kg oral tablets

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.

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • School children

Exclusion Criteria:

  • Taking praziquantel
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558336

Locations
Sudan
Al Salamania
Al Salamania, Nile, Sudan
Sponsors and Collaborators
University of Khartoum
Hikma
  More Information

Publications:

Responsible Party: Ishag Adam, Professor, University of Khartoum
ClinicalTrials.gov Identifier: NCT01558336     History of Changes
Other Study ID Numbers: Schistosmiasis
Study First Received: March 16, 2012
Last Updated: January 16, 2013
Health Authority: Sudan: Ministry of Health

Keywords provided by University of Khartoum:
Schistosoma haematobium
schoolchildren
Central Sudan
Praziquantel

Additional relevant MeSH terms:
Schistosomiasis haematobia
Schistosomiasis
Urinary Tract Infections
Infection
Trematode Infections
Helminthiasis
Parasitic Diseases
 Urologic Diseases
Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013