Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287300
• Other study ID #: 03-EPID-153
• Status: Completed
• Phase: N/A
• First received: February 3, 2006
• Last updated: February 3, 2006
• Start date: September 2003
• Est. completion date: August 2005

Study information

• Verified date: January 2006
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Sulfadoxine-Pyrimethamine

• Azithromycin

• Artesunate

Locations

Country	Name	City	State
Malawi	Mpemba and Madziabango Health Centers	Blantyre

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina	Centers for Disease Control and Prevention

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parasitological failure rates
Primary	Parasite clearance time
Primary	Fever clearance times
Primary	Incidence rate of adverse events
Secondary	Prevalence rate of abortions
Secondary	Prevalence rate of still births
Secondary	Prevalence rate of peripheral parasitemia at delivery
Secondary	Prevalence of placental malaria (thick blood film and histology)
Secondary	Prevalence rate of maternal anemia