NCT00164255

Brief Summary

This study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing placental parasitemia at delivery. If intermittent protective SP/AS treatment is equally efficacious and safe as intermittent protective SP, such a regimen could be adapted for programmatic use as a potentially more durable alternative to SP monotherapy in areas of increasing SP resistance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,614

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

6.4 years

First QC Date

September 9, 2005

Last Update Submit

September 10, 2012

Conditions

Malaria

Keywords

malariabirthweightplacental malariaintermittent protective treatmentsulfadoxine/ pyrimethamineartesuatecombination therapyPregnancy

Outcome Measures

Primary Outcomes (2)

  • placental parasitemia

  • reported or noted adverse reactions

Secondary Outcomes (6)

  • parasitemia at delivery (maternal peripheral, placental and cord)

  • maternal illness

  • birth weight

  • gestational age

  • fetal and infant health

  • +1 more secondary outcomes

Interventions

sulfadoxine/pyrimethamineDRUG
sulfadoxine/pyrimethamine plus artesunateDRUG

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women 15 years of age or older
  • First or second pregnancy between 16 and 36 weeks gestation

You may not qualify if:

  • Pregnancy prior to 16 weeks or after 36 weeks gestation
  • Third or later pregnancy;
  • Report previous allergic reactions to SP, AS, or unknown antimalarials;
  • If the distance to their home is too great or too inaccessible for follow-up;
  • Child's father refuses the woman's participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kibaoni Health Centre

Ifakara, Kilombero District, Tanzania

Location

St Francis Designated District Hospital

Ifakara, Kilombero District, Tanzania

Location

Related Publications (1)

  • Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.

    PMID: 39324693DERIVED

MeSH Terms

Conditions

MalariaBirth Weight

Interventions

fanasil, pyrimethamine drug combinationSulfadoxinePyrimethamineArtesunate

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsSesquiterpenesTerpenes

Study Officials

  • John MacArthur, MD, MPH

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Salim Abdulla, MD, PhD

    Ifakara Health Research and Development Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

January 1, 2003

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations

TA(2)