Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women

February 3, 2006 updated by: University of North Carolina

A Pilot Randomized Controlled Trial of Azithromycin or Artesunate Added to Sulphadoxine Pyrimethamine as Therapy for Malaria in Pregnancy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Malaria infection during pregnancy poses substantial risk to the mother, her fetus, and the neonate. Prevention of malaria during pregnancy is vital in decreasing maternal and child mortality in Africa. There are data from studies that show that intermittent preventive treatment (IPT) with two doses of sulfadoxine-pyrimethamine (SP) is safe, efficacious, and effective in preventing maternal anemia, placental parasitemia, and LBW. Resistance to SP, however, is increasing rapidly in Africa and there is an urgent need to find alternative effective, safe and affordable drugs for the treatment and prevention of malaria in pregnancy.

The investigators conducted a trial to determine the efficacy and safety of azithromycin and artesunate combined with sulphadoxine-pyrimethamine as treatment against malaria during pregnancy.Pregnant women 14 to 26 weeks gestation with P. falciparum parasitemia on peripheral blood film were randomly assigned into 3 treatment groups and received two doses of:(1) SP (3 tablets) only; (2) SP and azithromycin (1gram/day x 2 days)and (3) SP and artesunate 200mg/day for 3 days). The two doses of the study drug were administered approximately 4 weeks apart. All study drugs were taken under observation.Blood samples were collected on days 1, 2, 3, 7 and 14 after treatment and at any visit when the women presented with symptoms of malaria. The women were also given an insecticide-treated net (ITN) and followed until delivery. Adverse effects were assessed at each scheduled visit, any unscheduled visits during the study, and at delivery. Peripheral and placental blood films and placental biopsies were prepared at delivery. Newborns were weighed, examined, and gestational age was determined.

Study Type

Interventional

Enrollment

141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Blantyre, Malawi
        • Mpemba and Madziabango Health Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Parasite clearance time
Parasitological failure rates
Fever clearance times
Incidence rate of adverse events

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

February 3, 2006

First Submitted That Met QC Criteria

February 3, 2006

First Posted (Estimate)

February 6, 2006

Study Record Updates

Last Update Posted (Estimate)

February 6, 2006

Last Update Submitted That Met QC Criteria

February 3, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-EPID-153

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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