NCT00287300

Brief Summary

The purpose of this study is to compare the efficacy and safety of three treatment regimens for the prevention of malaria during pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2003

Typical duration for not_applicable

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

September 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
Last Updated

February 6, 2006

Status Verified

January 1, 2006

First QC Date

February 3, 2006

Last Update Submit

February 3, 2006

Conditions

Malaria

Keywords

MalariaPregnancyEfficacyAzithromycinArtesunate

Outcome Measures

Primary Outcomes (4)

  • Parasitological failure rates

  • Parasite clearance time

  • Fever clearance times

  • Incidence rate of adverse events

Secondary Outcomes (5)

  • Prevalence rate of abortions

  • Prevalence rate of still births

  • Prevalence rate of peripheral parasitemia at delivery

  • Prevalence of placental malaria (thick blood film and histology)

  • Prevalence rate of maternal anemia

Interventions

Sulfadoxine-PyrimethamineDRUG
AzithromycinDRUG
ArtesunateDRUG

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • peripheral malaria parasitemia
  • signed informed consent
  • age 15-49 years
  • mother has felt the movements of the foetus (quickening)
  • fetal age of at least 14 but not more than 26 completed gestation weeks
  • maternal availability for follow-up during the entire period of the study

You may not qualify if:

  • known maternal tuberculosis, diabetes, kidney disease, or liver disease
  • mental disorder that may affect comprehension of the study or success of follow-up
  • twin pregnancy
  • pregnancy complications evident at enrollment visit (moderate to severe oedema, blood Hb concentration \< 7 g / dl, systolic blood pressure (BP) \> 160 mmHg or diastolic BP \> 100 mmHg)
  • prior receipt of azithromycin during current pregnancy
  • receipt of any antimalarial within 28 days before enrollment
  • known allergy to drugs containing sulfonamides, macrolides or pyrimethamine
  • history of anaphylaxis
  • history of any serious allergic reaction to any substance, requiring emergency medical care
  • history of hepatitis or jaundice
  • concurrent participation in any other clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mpemba and Madziabango Health Centers

Blantyre, Malawi

Location

Related Publications (1)

  • Kalilani L, Mofolo I, Chaponda M, Rogerson SJ, Alker AP, Kwiek JJ, Meshnick SR. A randomized controlled pilot trial of azithromycin or artesunate added to sulfadoxine-pyrimethamine as treatment for malaria in pregnant women. PLoS One. 2007 Nov 14;2(11):e1166. doi: 10.1371/journal.pone.0001166.

    PMID: 18000538DERIVED

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combinationAzithromycinArtesunate

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsSesquiterpenesTerpenesHydrocarbons

Study Officials

  • Steve R Meshnick, M.D., Ph.D.

    2. Department of Epidemiology, School of Public Health, University of North Carolina, Chapel Hill NC USA

    PRINCIPAL INVESTIGATOR

  • Stephen J Rogerson, MB BS, Ph.D.

    3. Department of Medicine, University of Melbourne, Royal Melbourne Hospital, Parkville Victoria Australia

    PRINCIPAL INVESTIGATOR

  • Marjorie Chaponda, MB BS, MPH

    1. UNC Malaria Project, Department of Community Health, College of Medicine, University of Malawi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2006

First Posted

February 6, 2006

Study Start

September 1, 2003

Study Completion

August 1, 2005

Last Updated

February 6, 2006

Record last verified: 2006-01

Locations

MA(1)