NCT00274235

Brief Summary

Malaria in pregnancy is one of the most important preventable causes of low birthweight worlwide and a major cause of severe maternal anaemia contributing to maternal mortality. Intermittent Preventive Treatment (IPT) with sulfadoxine-pyrimethamine (SP) is the currently adopted government recommendation for malaria control during pregnancy in Benin, but the emergence and the spread of resistance to SP justifies the evaluation of alternative anti-malarial drugs. Mefloquine (MQ), which has been proven effective and reasonably safe in this indication, may be an interesting alternative to SP. The aim of this trial is to compare the efficacy and safety of sulfadoxine-pyrimethamine and mefloquine for IPT. It is an equivalent study designed to test the hypothesis that MQ is as efficacious as SP to prevent malaria in pregnancy, and that it could replace SP when resistance of Plasmodium falciparum becomes too elevated. Primary endpoint will be the proportion of infants with low birthweight. Secondary endpoints will be the proportion of mothers with placental plasmodial infection, and the proportion of mothers with anaemia at delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2005

Typical duration 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

July 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

October 31, 2008

Status Verified

October 1, 2008

Enrollment Period

2.7 years

First QC Date

January 9, 2006

Last Update Submit

October 30, 2008

Conditions

Malaria

Keywords

MalariaPreventionPregnancyLow birthweightAnemiaAfrica

Outcome Measures

Primary Outcomes (1)

  • proportion of infants with low birthweight (<2,500 grams)

Secondary Outcomes (8)

  • mean birthweight

  • proportion of mothers with placental plasmodial infection

  • proportion of preterm deliveries

  • proportion of mothers with anaemia (Haemoglobin level (Hb)<11g/dl) and severe anaemia (Hb<8g/dl) at delivery

  • proportion of mothers with parasitaemia at delivery

  • +3 more secondary outcomes

Interventions

sulfadoxine-pyrimethamine / mefloquineDRUG

Eligibility Criteria

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

You may qualify if:

  • Pregnancy between 16 and 28 weeks of gestation
  • Residence near the maternity clinics
  • Intention to continue the ante-natal care and deliver at the study maternity clinic
  • Ability to take drugs by oral route
  • Written informed consent (parents or guardian if aged \< 18 years)

You may not qualify if:

  • Pregnancy prior to 16 weeks or after 28 weeks of gestation
  • Previous suspected reaction to sulfadoxine-pyrimethamine or mefloquine
  • History of neurological or psychiatric event
  • Intake of sulfadoxine-pyrimethamine or mefloquine within 4 weeks of enrollment
  • Current treatment with halofantrine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherche pour le Développement

Cotonou, 01 BP 4414 RP, Benin

Location

Related Publications (2)

  • Briand V, Bottero J, Noel H, Masse V, Cordel H, Guerra J, Kossou H, Fayomi B, Ayemonna P, Fievet N, Massougbodji A, Cot M. Intermittent treatment for the prevention of malaria during pregnancy in Benin: a randomized, open-label equivalence trial comparing sulfadoxine-pyrimethamine with mefloquine. J Infect Dis. 2009 Sep 15;200(6):991-1001. doi: 10.1086/605474.

    PMID: 19656069DERIVED

  • Briand V, Denoeud L, Massougbodji A, Cot M. Efficacy of intermittent preventive treatment versus chloroquine prophylaxis to prevent malaria during pregnancy in Benin. J Infect Dis. 2008 Aug 15;198(4):594-601. doi: 10.1086/590114.

    PMID: 18598190DERIVED

MeSH Terms

Conditions

MalariaAnemia

Interventions

mefloquine-sulfadoxine-pyrimethamine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Michel Cot, MD

    Institut de Recherche pour le Developpement

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 9, 2006

First Posted

January 10, 2006

Study Start

July 1, 2005

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

October 31, 2008

Record last verified: 2008-10

Locations

BE(1)