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Sponsors and Collaborators: |
University of North Carolina Centers for Disease Control and Prevention |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00287300 |
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 |
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Malaria |
Drug: Sulfadoxine-Pyrimethamine Drug: Azithromycin Drug: Artesunate |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Randomized Controlled Trial of Azithromycin or Artesunate Added to Sulphadoxine Pyrimethamine as Therapy for Malaria in Pregnancy |
Estimated Enrollment: | 141 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | August 2005 |
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.
Ages Eligible for Study: | 15 Years to 49 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Malawi | |
Mpemba and Madziabango Health Centers | |
Blantyre, Malawi |
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 |
Study ID Numbers: | 03-EPID-153 |
Study First Received: | February 3, 2006 |
Last Updated: | February 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00287300 History of Changes |
Health Authority: | United States: Institutional Review Board |
Malaria Pregnancy Efficacy Azithromycin Artesunate |
Pyrimethamine Artesunate Protozoan Infections Sulfadoxine-pyrimethamine Malaria Anti-Infective Agents, Urinary Sulfadoxine |
Folic Acid Antagonists Folic Acid Antimalarials Anti-Bacterial Agents Azithromycin Parasitic Diseases |
Pyrimethamine Artesunate Protozoan Infections Anti-Infective Agents Sulfadoxine-pyrimethamine Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Anti-Infective Agents, Urinary Enzyme Inhibitors Malaria |
Renal Agents Folic Acid Antagonists Sulfadoxine Pharmacologic Actions Anti-Bacterial Agents Antimalarials Antiparasitic Agents Therapeutic Uses Azithromycin Parasitic Diseases Amebicides |