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

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ClinicalTrials.gov Identifier: NCT00538382
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : July 31, 2014
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
John E. Fogarty International Center (FIC)
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
RTI International
University of North Carolina
Kinshasa School of Public Health
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health

Brief 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.

Condition or disease Intervention/treatment Phase
Malaria Drug: Artesunate Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Phase I Study of Pharmacokinetics and Pharmacodynamics of Artesunate in Pregnant Women in the Democratic Republic of Congo
Study Start Date : May 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Case
Cases are defined as parasitemic pregnant women during the second trimester (22-26 weeks gestation) and the third trimester (32-36 weeks gestation).
Drug: Artesunate
A 200 mg dose of orally administered artesunate at the beginning of a 48-hour clinical sampling period.
Other Name: Arsumax®
Active Comparator: Non-pregnant Control
Non-pregnant controls are defined as parasitemic non-pregnant women recruited from the same community as the cases.
Drug: Artesunate
A 200 mg dose of orally administered artesunate at the beginning of a 48-hour clinical sampling period.
Other Name: Arsumax®
Active Comparator: Internal Control
Internal controls are defined as the same women(cases)at three months postpartum.
Drug: Artesunate
A 200 mg dose of orally administered artesunate at the beginning of a 48-hour clinical sampling period.
Other Name: Arsumax®



Primary Outcome Measures :
  1. Levels of the unbound active major metabolite, dihydroartemisinin (DHA), will be similar for parasitemic pregnant women during their 2nd and 3rd trimesters vs. the same women 3 months postpartum [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. The levels of unbound DHA will be similar for parasitemic pregnant women (during the second and third trimesters) vs. parasitemic non-pregnant women. [ Time Frame: 48 hours after drug administration ]
  2. The pharmacokinetics of ARTS and total DHA will be similar for parasitemic pregnant women (during the second and third trimesters) vs. the same women three months postpartum and parasitemic non-pregnant women. [ Time Frame: 48 hours after drug administration ]
  3. The pharmacodynamics of therapy will be similar for parasitemic pregnant women (during the 2nd and 3rd trimesters) vs. parasitemic non-pregnant women. Pharmacodynamics will be determined by measuring the parasite clearance time (PCT), PC50, and PC90. [ Time Frame: 48 hours after drug administration ]
  4. The pharmacodynamics and pharmacokinetic outcomes (as elaborated above) will be similar between the 2nd and 3rd trimester in parasitemic pregnant women. [ Time Frame: 48 hours after drug administration ]
  5. Description of safety and tolerability of Artesunate in the target population (pregnant women in the 2nd and 3rd trimester). [ Time Frame: 0ne year postpartum ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538382


Locations
Congo, The Democratic Republic of the
Kingasani Maternity Clinic
Kinshasa, Congo, The Democratic Republic of the
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
John E. Fogarty International Center (FIC)
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
RTI International
University of North Carolina
Kinshasa School of Public Health
Investigators
Principal Investigator: Carl Bose, M.D. University of North Carolina
Principal Investigator: Antoinette Tshefu, M.D., M.P.H. Kinshasa School of Public Health

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00538382     History of Changes
Other Study ID Numbers: GN02- PK/PD of artesunate
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014

Keywords provided by NICHD Global Network for Women's and Children's Health:
Malaria
Pregnancy
Artesunate
Pharmacokinetics
Pharmacodynamics
Democratic Republic of Congo

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Artemisinins
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials