NCT01328990

Brief Summary

The aim of the study is to determine the pharmacokinetic profile of sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) when used for seasonal Intermittent Preventive Treatment (IPT) to prevent malaria in children aged 3 to 59 months in Lamarame, NDoffane District, Senegal. Several studies have shown that seasonal IPT in children can provide a high degree of protection against clinical malaria. SP+AQ is the most effective regimen. However little is known about the pharmacokinetics of amodiaquine and sulfadoxine-pyrimethamine in children. The purpose of this study is to determine the pharmacokinetics profile of SP+AQ when used for IPT in Senegalese children. 150 children aged 3 to 59 months will be enrolled in November. They will receive a therapeutic dose of sulfadoxine-pyrimethamine and amodiaquine, and will be followed up for 30 days. Four finger prick blood samples will be taken from each child for PK analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

September 19, 2011

Status Verified

September 1, 2011

Enrollment Period

3 months

First QC Date

April 4, 2011

Last Update Submit

September 16, 2011

Conditions

Malaria

Keywords

IPTcmalariachildrenpharmacokineticsamodiaquianesulfadoxine-pyrimethamine

Outcome Measures

Primary Outcomes (1)

  • Concentration of sulfadoxine, pyrimethamine, and desethylamodiaquine

    Concentration of the drugs will be measured at four time points.

    28 days

Secondary Outcomes (1)

  • Tolerability

    28 days

Interventions

sulfadoxine-pyrimethamine plus amodiaquineDRUG

one dose of sulfadoxine-pyrimethamine 25/1.25 mg/kg plus three daily doses of amodiaquine, 10 mg/kg/day

Eligibility Criteria

Age3 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age 3 months to 5 years
  • no allergy to study drugs
  • consent from parent or guardian

You may not qualify if:

  • chronic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universite Chiekh Anta Diop

Dakar, Senegal

Location

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combinationAmodiaquine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Badara Cisse, PhD

    Universite Chiekh Anta Diop

    STUDY CHAIR

  • Paul Milligan, PhD

    London School of Hygiene and Tropical Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2011

First Posted

April 5, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 19, 2011

Record last verified: 2011-09

Locations

SE(1)