Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women
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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 |
- Parasitological failure rates
- Parasite clearance time
- Fever clearance times
- Incidence rate of adverse events
- 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 |
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 |
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| 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 |
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 Pyrimethamine Sulfadoxine Artesunate Sulfadoxine-pyrimethamine Azithromycin Antimalarials Antiprotozoal Agents Antiparasitic Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents Amebicides Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013