Efficacy of Combination Therapy for Prevention of Effects of Malaria During Pregnancy - Full Text View

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

This study is currently recruiting participants.
Verified by Centers for Disease Control and Prevention, September 2005

Sponsors and Collaborators:	Centers for Disease Control and Prevention Ifakara Health Research and Development Centre
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00164255

Purpose

This study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing placental parasitemia at delivery. If intermittent protective SP/AS treatment is equally efficacious and safe as intermittent protective SP, such a regimen could be adapted for programmatic use as a potentially more durable alternative to SP monotherapy in areas of increasing SP resistance.

Condition	Intervention	Phase
Malaria	Drug: sulfadoxine/pyrimethamine Drug: sulfadoxine/pyrimethamine plus artesunate	Phase IV

MedlinePlus related topics:

Malaria

Drug Information available for:

Pyrimethamine Sulfadoxine Artesunate Fansidar Chloroquine Chloroquine diphosphate Chloroquine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Efficacy of Intermittent Sulfadoxine-Pyrimethamine and Sulfadoxine-Pyrimethamine + Artesunate Treatment in the Prevention of Malaria in Pregnancy in an Area With Chloroquine-Resistant Plasmodium Falciparum

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

placental parasitemia
reported or noted adverse reactions

Secondary Outcome Measures:

parasitemia at delivery (maternal peripheral, placental and cord)
maternal illness
birth weight
gestational age
fetal and infant health
impact of maternal HIV infection on efficacy of malaria prevention during pregnancy

Estimated Enrollment:	452
Study Start Date:	January 2003

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Women 15 years of age or older
First or second pregnancy between 16 and 36 weeks gestation

Exclusion Criteria:

Pregnancy prior to 16 weeks or after 36 weeks gestation
Third or later pregnancy;
Report previous allergic reactions to SP, AS, or unknown antimalarials;
If the distance to their home is too great or too inaccessible for follow-up;
Child’s father refuses the woman’s participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164255

Contacts


Contact: John Macarthur, MD, MPH	770-488-7755	ZAE5@CDC.GOV

Contact: Peter Bloland, DVM, MPVM	770-488-7787	PBB1@CDC.GOV

Locations


Tanzania, Kilombero District
	St Francis Designated District Hospital	Recruiting
	Ifakara, Kilombero District, Tanzania
	Contact: Mulokozi Abdunoor, MD 255-(0)22-213-2704
	Sub-Investigator: Mulokozi Abdunoor, MD
	Kibaoni Health Centre	Recruiting
	Ifakara, Kilombero District, Tanzania
	Contact: Mulokozi Abdunoor, MD 255-(0)22-213-2704
	Sub-Investigator: Mulokozi Abdunoor, MD

Sponsors and Collaborators

Centers for Disease Control and Prevention

Ifakara Health Research and Development Centre

Investigators


Principal Investigator:	John MacArthur, MD, MPH	Centers for Disease Control and Prevention

Principal Investigator:	Salim Abdulla, MD, PhD	Ifakara Health Research and Development Centre

More Information

Study ID Numbers:	CDC-NCID-3807, UR3/CCU018969-01
First Received:	September 9, 2005
Last Updated:	March 7, 2006
ClinicalTrials.gov Identifier:	NCT00164255
Health Authority:	United States: Federal Government; Tanzania: National Institute for Medical Research

Keywords provided by Centers for Disease Control and Prevention:

malaria

birthweight

placental malaria

intermittent protective treatment

sulfadoxine/ pyrimethamine

artesuate

combination therapy

Pregnancy

Study placed in the following topic categories:

Folic Acid

Artesunate

Pyrimethamine

Birth Weight

Protozoan Infections

Sulfadoxine-pyrimethamine

Chloroquine diphosphate

Chloroquine

Parasitic Diseases

Malaria

Sulfadoxine

Additional relevant MeSH terms:

Anti-Infective Agents

Antiprotozoal Agents

Molecular Mechanisms of Pharmacological Action

Coccidiosis

Enzyme Inhibitors

Anti-Infective Agents, Urinary

Folic Acid Antagonists

Renal Agents

Pharmacologic Actions

Antimalarials

Antiparasitic Agents

Therapeutic Uses

Amebicides

ClinicalTrials.gov processed this record on October 23, 2008