NCT01558336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

4 years

First QC Date

March 16, 2012

Last Update Submit

January 16, 2013

Conditions

Schistosomiasis

Keywords

Schistosoma haematobiumschoolchildrenCentral SudanPraziquantel

Outcome Measures

Primary Outcomes (1)

  • cure rate

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

    one year

Secondary Outcomes (1)

  • reduction in the intensity of infection by

    one year

Study Arms (1)

Praziguantel

EXPERIMENTAL

tablet single dose

Drug: praziquantel

Interventions

praziquantelDRUG

praziquantel 40 mg/kg oral tablets

Praziguantel

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • School children

You may not qualify if:

  • Taking praziquantel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Salamania

Al Salamania, River Nile, Sudan

Location

Related 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.

    PMID: 21729382RESULT

MeSH Terms

Conditions

SchistosomiasisSchistosomiasis haematobia

Interventions

Praziquantel

Condition Hierarchy (Ancestors)

Trematode InfectionsHelminthiasisParasitic DiseasesInfectionsVector Borne DiseasesUrinary Tract InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 16, 2012

First Posted

March 20, 2012

Study Start

August 1, 2008

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

SU(1)