NCT01054651

Brief Summary

The purpose of this study is to determine the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children infected with S.mansoni in western Kenya.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2009

Shorter than P25 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

October 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
Last Updated

January 22, 2010

Status Verified

January 1, 2010

Enrollment Period

2 months

First QC Date

January 21, 2010

Last Update Submit

January 21, 2010

Conditions

Schistosoma Mansoni

Keywords

Schistosoma mansoniPraziquantelArtesunate + Sulfamethoxypyrazine/pyrimethamineRandomized open-label controlled clinical trial

Outcome Measures

Primary Outcomes (1)

  • Compare the cure rate between the two treatment arms

    after 28 days

Secondary Outcomes (3)

  • Compare the proportion of children excreting schistosoma eggs between the two treatment arms

    after 28 days

  • Compare the amount of eggs produced between the two arms

    after 28 days

  • Compare the incidence of clinical and biological adverse events

    after 28 days

Study Arms (2)

Artesunate+Sulfamethoxypyrazine/pyrimethamine

EXPERIMENTAL
Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamine

Praziquantel

ACTIVE COMPARATOR
Drug: Praziquantel

Interventions

Artesunate+Sulfamethoxypyrazine/pyrimethamineDRUG
Also known as: Co-arinate FDC
Artesunate+Sulfamethoxypyrazine/pyrimethamine
PraziquantelDRUG
Also known as: Biltricide
Praziquantel

Eligibility Criteria

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

You may qualify if:

  • Aged between 6 and 15 years old
  • Study participants appear healthy at enrollment, as assessed by the study clinician
  • Suffering from S. mansoni infection, excreting eggs in stool
  • Residing in Uyoma area, near Lake Victoria
  • Able to receive oral treatment
  • Parent/legal guardian gives informed written consent for the child to participate in the study
  • Child assent to participate in study

You may not qualify if:

  • Weighing more than 50 kg
  • Pregnant or lactating at the time of the study
  • Presence of infection with Plasmodium falciparum or other Plasmodium spp.
  • Presence of severe illness, such as cerebral cysticercosis
  • Signs of severe malnutrition (defined as children with weight/height ratio below 3 standard deviations or below 70% of the median of the WHO standardized reference values, or still with symmetrical oedema affecting both feet)
  • Hypersensitivity to As, sulfonamides or PZQ.
  • Use of another anti-malaria or anti-schistosomal drug during the study, or within 28 days before the administration of treatment.
  • Previous participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KEMRI Centre for Global Health Research

Kisumu, Kenya

Location

Related Publications (1)

  • Obonyo CO, Muok EM, Mwinzi PN. Efficacy of artesunate with sulfalene plus pyrimethamine versus praziquantel for treatment of Schistosoma mansoni in Kenyan children: an open-label randomised controlled trial. Lancet Infect Dis. 2010 Sep;10(9):603-11. doi: 10.1016/S1473-3099(10)70161-4. Epub 2010 Aug 10.

    PMID: 20705516DERIVED

MeSH Terms

Conditions

Schistosomiasis

Interventions

PyrimethaminePraziquantel

Condition Hierarchy (Ancestors)

Trematode InfectionsHelminthiasisParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

PyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Pauline N Mwinzi, PhD

    Kenya Medical Research Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 21, 2010

First Posted

January 22, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 22, 2010

Record last verified: 2010-01

Locations

KE(1)