NCT00941785

Brief Summary

The aim of the study is to determine whether piperaquine plus dihydroartemisinin (DHA-PQ) is as effective, and better tolerated, than 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 Bobo-Dioulasso, Burkina Faso and to determine the pharmacokinetics of piperaquine in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2009

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2009

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 20, 2009

Completed
4 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
Last Updated

March 21, 2011

Status Verified

March 1, 2011

Enrollment Period

5 months

First QC Date

June 18, 2009

Last Update Submit

March 18, 2011

Conditions

Malaria

Keywords

MalariaIntermittent Preventive TreatmentIPTcsIPTcBurkina Faso

Outcome Measures

Primary Outcomes (2)

  • Efficacy against clinical malaria

    August to December 2009

  • Incidence of adverse events

    Within 7 days of each treatment round and within 1 month of treatment

Secondary Outcomes (1)

  • Pharmacokinetics of piperaquie: the oral clearance (CL/F), AUC, steady state volume of distribution(s) (Vss/F), inter-compartment clearance(s) (Q/F) and absorption rate (ka) will be estimated.

    during 30 days after start of treatment

Study Arms (2)

DHA-PQ

EXPERIMENTAL

Three monthly administrations of dihydroartemisinin (DHA) plus piperaquine (PQ) in August, September and October.

Drug: DHA-PQ

SP-AQ

ACTIVE COMPARATOR

Three monthly administrations of sulfadoxine-pyrimethamine plus amodiaquine

Drug: SP-AQ

Interventions

DHA-PQDRUG

Three monthly administrations of Duocotexcin (DHA-PQ): dihydroartemisinin 2.1mg/kg and piperaquine phosphate 16.8 mg/kg once daily for three days

Also known as: Seasonal IPTc with Duocotexcin (Holley)
DHA-PQ
SP-AQDRUG

Three monthly administrations of sulfadoxine-pyrimethamine plus amodiaquine: One dose of Sulfadoxine 25mg/kg and pyrimethamine 1.25mg/kg Three daily doses of amodiaquine phosphate 10mg/kg

Also known as: Seasonal IPTc with Fansidar plus amodiaquine (Flavoquine)
SP-AQ

Eligibility Criteria

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

You may qualify if:

  • signed consent from a parent
  • age 3-59 months at enrolment
  • no history of allergy to study drugs
  • no chronic illness

You may not qualify if:

  • history of allergy to study drugs
  • intention to move away from the study area before the end of 2009
  • any chronic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRSS

Bobo-Dioulasso, Bobo-Dioulasso, BP545, Burkina Faso

Location

Related Publications (2)

  • Zongo I, Milligan P, Compaore YD, Some AF, Greenwood B, Tarning J, Rosenthal PJ, Sutherland C, Nosten F, Ouedraogo JB. Randomized Noninferiority Trial of Dihydroartemisinin-Piperaquine Compared with Sulfadoxine-Pyrimethamine plus Amodiaquine for Seasonal Malaria Chemoprevention in Burkina Faso. Antimicrob Agents Chemother. 2015 Aug;59(8):4387-96. doi: 10.1128/AAC.04923-14. Epub 2015 Apr 27.

    PMID: 25918149DERIVED

  • Some AF, Zongo I, Compaore YD, Sakande S, Nosten F, Ouedraogo JB, Rosenthal PJ. Selection of drug resistance-mediating Plasmodium falciparum genetic polymorphisms by seasonal malaria chemoprevention in Burkina Faso. Antimicrob Agents Chemother. 2014 Jul;58(7):3660-5. doi: 10.1128/AAC.02406-14. Epub 2014 Apr 14.

    PMID: 24733476DERIVED

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

  • Jean-Bosco Ouédraogo, MD

    IRSS, Direction Régionale,BP 545 Bobo-Dioulasso (Burkina Faso)

    STUDY DIRECTOR

  • Paul JM Milligan, PhD

    London School of Hygiene and Tropical Medicine

    STUDY CHAIR

  • Issaka Zongo, MD

    IRSS, Burkina Faso and LSHTM, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 18, 2009

First Posted

July 20, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 21, 2011

Record last verified: 2011-03

Locations

BU(1)