Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00287300
First received: February 3, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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


Condition Intervention
Malaria
Drug: Sulfadoxine-Pyrimethamine
Drug: Azithromycin
Drug: Artesunate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Randomized Controlled Trial of Azithromycin or Artesunate Added to Sulphadoxine Pyrimethamine as Therapy for Malaria in Pregnancy

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Parasitological failure rates
  • Parasite clearance time
  • Fever clearance times
  • Incidence rate of adverse events

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 141
Study Start Date: September 2003
Estimated Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287300

Locations
Malawi
Mpemba and Madziabango Health Centers
Blantyre, Malawi
Sponsors and Collaborators
University of North Carolina
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
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00287300     History of Changes
Other Study ID Numbers: 03-EPID-153
Study First Received: February 3, 2006
Last Updated: February 3, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Malaria
Pregnancy
Efficacy
Azithromycin
Artesunate

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Sulfadoxine
Pyrimethamine
Fanasil, pyrimethamine drug combination
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Anti-Infective Agents, Urinary
Renal Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014