NCT00231322

Brief Summary

To assess the influence of seasonal variations in Schistosoma haematobium transmission on treatment outcome (morbidity and re-infection)

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 not_applicable

Timeline
Completed

Started Mar 2004

Typical duration for not_applicable

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

March 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

April 20, 2007

Status Verified

April 1, 2007

First QC Date

September 30, 2005

Last Update Submit

April 19, 2007

Conditions

HematuriaHydronephrosis

Keywords

Schistosoma haematobiumhaematuriaultrasonographyUgandaVesical polyps

Outcome Measures

Primary Outcomes (4)

  • cure rate

  • egg reduction rate

  • re-infection prevalence and intensity of infection *resolution of urinary tract pathology

  • re-appearance of pathology after re-infection.

Secondary Outcomes (1)

  • reduction in worm burden (CAA);

Interventions

praziquantelDRUG

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children aged 8-12 years

You may not qualify if:

  • All children presenting with macro-haematuria or severe pathology detected by ultrasonography (large masses, pseudo-polyps or hydronephrosis/hydroureter) at the 6 months follow-up examination will be treated with praziquantel and excluded in the data analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Matola

Maputo, Maputo Province, Mozambique

Location

Related Links

MeSH Terms

Conditions

HematuriaHydronephrosisSchistosomiasis haematobia

Interventions

Praziquantel

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsKidney DiseasesSchistosomiasisTrematode InfectionsHelminthiasisParasitic DiseasesInfectionsUrinary Tract InfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Gerito Augusto, Msc

    Instituto Nacional de Saúde, Mozambique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

March 1, 2004

Study Completion

March 1, 2006

Last Updated

April 20, 2007

Record last verified: 2007-04

Locations

MO(1)