Study of Pharmacokinetics and Pharmacodynamics of Artesunate in Pregnant Women in the Democratic Republic of Congo

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of a standard dose of orally administered artesunate, in order to determine if the current adult dose (200 mg) is appropriate in parasitemic pregnant women when compared to the same women at three months postpartum and to parasitemic non-pregnant women. Preliminary evidence on safety, tolerability and efficacy will be gathered.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NICHD Global Network for Women's and Children's Health
• Collaborators: Bill and Melinda Gates Foundation; Fogarty International Center of the National Institute of Health; Global Network for Women's and Children's Health Research; John E. Fogarty International Center (FIC); Kinshasa School of Public Health; National Cancer Institute (NCI); National Center for Complementary and Integrative Health (NCCIH); National Institute of Dental and Craniofacial Research (NIDCR); RTI International; University of North Carolina
• Treatments: Artemisinins; Artesunate

Criteria

Inclusion Criteria for Cases:

• 2nd trimester (22-26 weeks) or 3rd trimester (32-36 weeks) of pregnancy, based on an ultrasound conducted at <22 weeks gestation (composite of BPD, HC, AC, FL)

• Singleton pregnancy documented by ultrasound

• Parasitemic (> 500 parasites/μl)

• Afebrile and asymptomatic

• Hematocrit ≥ 30%

• Negative HIV test result

• At least 18 years of age and less than 40 years of age

• Able to spend three days in the clinic following their laboratory screening visit and again at three months postpartum

• Willing to provide informed consent

Inclusion Criteria for Non-pregnant Controls:

• Negative urine pregnancy test

• Parasitemic (> 500 parasites/μl)

• Afebrile and asymptomatic

• Hematocrit ≥ 30%

• Negative Determine® HIV test result

• At least 18 years of age and less than 40 years of age

• Able to spend three days in the clinic following screening

• Willing to provide informed consent

Inclusion Criteria for Internal controls:

• Negative urine pregnancy test

Exclusion Criteria for Cases:

• Parasitemia > 300,000 parasites/μl or symptomatic malaria

• Medical contraindications to participation or medical disorders (known high blood pressure, diabetes, sickle cell disease or tuberculosis)

• Have taken artesunate or any medicine containing artesunate during the current pregnancy

• Have taken any antimalarial in the past two weeks

• Have taken any medication in the past two weeks other than antipyretics (e.g., acetyl- salicylic acid, acetaminophen), folic acid or iron

• Have a fetus with any ultrasonographically visible structural fetal abnormalities identified on entry by ultrasound

• Past or present pregnancy complications that would preclude participation in the study (gestational diabetes/diabetes, incompetent cervix, pre-eclampsia/ eclampsia, and high blood pressure)

• Between 32-36 weeks gestation and have already participated in the study at 22-26 weeks gestation

Exclusion Criteria for Non-pregnant Controls:

• Parasitemia > 300,000 parasites/μl or have symptomatic malaria

• Medical contraindications to participation or medical disorders (known high blood pressure, diabetes, sickle cell disease or tuberculosis)

• Have taken any antimalarial in the past two weeks

• Have taken any medication in the past two weeks other than antipyretics (e.g., acetyl- salicylic acid, acetaminophen), folic acid or iron

Exclusion Criteria for Internal Controls:

• Parasitemia > 300,000 parasites/μl or have symptomatic malaria

• Have taken antimalarial medication in the past two weeks.

• Have taken any medication in the past two weeks other than antipyretics (e.g., acetyl- salicylic acid, acetaminophen), folic acid or iron

• Pregnant