NCT00510159

Brief Summary

The purpose of this study is to evaluate the efficacy of praziquantel versus As+SMP (Co-Arinate FDC ®) in the treatment of Schistosoma haematobium in 6-15 year old Malian children. The nul-hypothesis in this study is that the combination of As+SMP is more effective than praziquantel in the treatment of S. haematobium infected children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

July 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 18, 2008

Status Verified

July 1, 2007

Enrollment Period

2 months

First QC Date

July 31, 2007

Last Update Submit

January 17, 2008

Conditions

Schistosoma Haematobium

Keywords

Schistosoma haematobiumPraziquantelArtesunate + Sulfamethoxypyrazine/pyrimethamineRandomized double blind placebo controlled clinical trial

Outcome Measures

Primary Outcomes (3)

  • Compare the parasite load between the two treatment arms

    After 28 days

  • Compare the amount of eggs produced between the two treatment arms

    After 28 days

  • Compare cure rate between the two treatment arms

    After 28 days

Secondary Outcomes (2)

  • Evaluate changes in urine appearance before and after treatment

    After 28 days

  • Evaluate changes in haematuria frequency before and after treatment

    After 28 days

Interventions

Artesunate+Sulfamethoxypyrazine/pyrimethaminDRUG
Also known as: Co-Arinate FDC ®
PraziquantelDRUG

Eligibility Criteria

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

You may qualify if:

  • Aged between 6-15 years
  • In good health, according to study doctor
  • Suffering from urinary schistosomiasis, as diagnosed by the presence of S. haematobium eggs in the urine.
  • Residents of Djalakorodji
  • Capable of taking oral medication
  • Written informed consent to participate in the study, obtained from parent or legal guardian.

You may not qualify if:

  • Weighing more than 50 kg
  • Being pregnant or lactating at the time of the study
  • Patient has a severe concomitant disease, as determined by the clinical examination, such as cerebral cysticercosis, HIV,...
  • Signs of severe malnutrition (children weighing/measuring more than 3 standard deviations or less than 70% of the median standard reference values determined by WHO, or with systemic oedema affecting both feet).
  • Hypersensitivity to As, SMP or PZQ
  • Having taken other antimalarial or antischistosomal medication during the study.
  • Having participated in previous similar studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Djalakorodji, Mali

Location

Related Publications (1)

  • Sissoko MS, Dabo A, Traore H, Diallo M, Traore B, Konate D, Niare B, Diakite M, Kamate B, Traore A, Bathily A, Tapily A, Toure OB, Cauwenbergh S, Jansen HF, Doumbo OK. Efficacy of artesunate + sulfamethoxypyrazine/pyrimethamine versus praziquantel in the treatment of Schistosoma haematobium in children. PLoS One. 2009 Oct 5;4(10):e6732. doi: 10.1371/journal.pone.0006732.

    PMID: 19802383DERIVED

MeSH Terms

Conditions

Schistosomiasis haematobia

Interventions

Praziquantel

Condition Hierarchy (Ancestors)

SchistosomiasisTrematode InfectionsHelminthiasisParasitic DiseasesInfectionsUrinary Tract InfectionsVector Borne DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Mahamadou S Sissoko, MD, MSPH

    University of Bamako, Mali

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 31, 2007

First Posted

August 1, 2007

Study Start

August 1, 2007

Primary Completion

October 1, 2007

Study Completion

December 1, 2007

Last Updated

January 18, 2008

Record last verified: 2007-07

Locations

MA(1)