Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women

2014-08-27 03:46:17 | BioPortfolio


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


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

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




Sulfadoxine-Pyrimethamine, Azithromycin, Artesunate


Mpemba and Madziabango Health Centers




University of North Carolina, Chapel Hill

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:46:17-0400

Clinical Trials [709 Associated Clinical Trials listed on BioPortfolio]

ACT MALI: Treatment of Malaria Based on Combination Therapies

Test the hypothesis that repeated administration of Artesunate/Amiodaquine, Artesunate/Sulfadoxine-Pyrimethamine and Arthemeter-Lufemantrine for the treatment of consecutive episodes of un...

Gestational Sulfadoxine-Pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth

The purpose of this study is to examine whether treatment of pregnant Malawian women with repeated doses of sulfadoxine-pyrimethamine and azithromycin antibiotics will prevent preterm deli...

A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria

The purpose of this study is to determine the efficacy of sulfadoxine-pyrimethamine plus artesunate versus sulfadoxine-pyrimethamine alone in the treatment of uncomplicated malaria.

A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria

The purpose of this study is to compare the efficacy of sulfadoxine-pyrimethamine plus artesunate with that of sulfadoxine-pyrimethamine on its own for the treatment of uncomplicated malar...

Efficacy of Combination Therapy for Prevention of Effects of Malaria During Pregnancy

This study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine (SP) + art...

PubMed Articles [514 Associated PubMed Articles listed on BioPortfolio]

Prevalence of Plasmodium falciparum parasites resistant to sulfadoxine/pyrimethamine in the Democratic Republic of the Congo: emergence of highly resistant pfdhfr/pfdhps alleles.

In 2005, the Democratic Republic of the Congo (DRC) switched to artesunate/amodiaquine as the first-line antimalarial in response to increasing sulfadoxine/pyrimethamine resistance and adopted intermi...

Impact on the transmission of malaria with different treatment schemes in the peruvian coast and amazon region within the framework of a policy on antimalarial medications, 1994-2017.

At the end of the 90s in Peru, after determining the resistance to antimalarial drugs, a change in antimalarial treatment schemes was decided; this change included the combined therapy for P. falcipar...

Chloroquine as weekly chemoprophylaxis or intermittent treatment to prevent malaria in pregnancy in Malawi: a randomised controlled trial.

Sulfadoxine-pyrimethamine resistance threatens efficacy of intermittent preventive treatment of malaria during pregnancy, and alternative regimens need to be identified. With the return of chloroquine...

Efficacy of artemisinin-based combination therapies and prevalence of molecular markers associated with artemisinin, piperaquine and sulfadoxine-pyrimethamine resistance in Sierra Leone.

Currently, the national malaria control programme (NMCP) of Sierra Leone recommends artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) as first- and second-line treatment for uncomplicated...

Dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria during pregnancy and risk of malaria in early childhood: A randomized controlled trial.

Intermittent preventive treatment of malaria in pregnancy (IPTp) with dihydroartemisinin-piperaquine (IPTp-DP) has been shown to reduce the burden of malaria during pregnancy compared to sulfadoxine-p...

Medical and Biotech [MESH] Definitions

Malaria caused by PLASMODIUM VIVAX. This form of malaria is less severe than MALARIA, FALCIPARUM, but there is a higher probability for relapses to occur. Febrile paroxysms often occur every other day.

A sulfone active against a wide range of bacteria but mainly employed for its actions against MYCOBACTERIUM LEPRAE. Its mechanism of action is probably similar to that of the SULFONAMIDES which involves inhibition of folic acid synthesis in susceptible organisms. It is also used with PYRIMETHAMINE in the treatment of malaria. (From Martindale, The Extra Pharmacopoeia, 30th ed, p157-8)

Vaccines made from antigens arising from any of the four strains of Plasmodium which cause malaria in humans, or from P. berghei which causes malaria in rodents.

A protozoan parasite that causes vivax malaria (MALARIA, VIVAX). This species is found almost everywhere malaria is endemic and is the only one that has a range extending into the temperate regions.

Malaria caused by PLASMODIUM FALCIPARUM. This is the severest form of malaria and is associated with the highest levels of parasites in the blood. This disease is characterized by irregularly recurring febrile paroxysms that in extreme cases occur with acute cerebral, renal, or gastrointestinal manifestations.

More From BioPortfolio on "Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women"

Quick Search


Relevant Topics

Malaria is a serious tropical disease spread by mosquitoes. If malaria is not diagnosed and treated promptly, it can be fatal. What causes malaria? Malaria is caused by a type of parasite known as Plasmodium. There are many different types of Plasmod...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial