ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 33 for:    Sudan

Schistosoma Haematobium Infections and Praziquantel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01558336
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : January 17, 2013
Sponsor:
Collaborator:
Hikma Pharmaceuticals LLC
Information provided by (Responsible Party):
Ishag Adam, University of Khartoum

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 Type : Interventional  (Clinical Trial)
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 : August 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. cure rate [ Time Frame: 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 [ Time Frame: one year ]
    will a single dose of PZQ significantly reduced intensity of infection of S. haematobium infection 1 year after treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • School children

Exclusion Criteria:

  • Taking praziquantel

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558336


Locations
Sudan
Al Salamania
Al Salamania, Nile, Sudan
Sponsors and Collaborators
University of Khartoum
Hikma Pharmaceuticals LLC

Publications of Results:
Responsible Party: Ishag Adam, Professor, University of Khartoum
ClinicalTrials.gov Identifier: NCT01558336     History of Changes
Other Study ID Numbers: Schistosmiasis
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013

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

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