Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women

Sponsor

University of North Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT00287300

Collaborator

Centers for Disease Control and Prevention (U.S. Fed)

141

Enrollment

Location

Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: Sulfadoxine-Pyrimethamine Drug: Azithromycin Drug: Artesunate	N/A

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2003

Study Completion Date :

Aug 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Mpemba and Madziabango Health Centers	Blantyre		Malawi

Sponsors and Collaborators

University of North Carolina
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