Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis

NCT ID: NCT00510159

Last Updated: 2008-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schistosoma Haematobium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Artesunate+Sulfamethoxypyrazine/pyrimethamin

Intervention Type DRUG

Praziquantel

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Co-Arinate FDC ®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dafra Pharma

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mahamadou S Sissoko, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Bamako, Mali

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Djalakorodji, , Mali

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mali

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 19802383 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2007/S4

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.