Study of Pharmacokinetics and Pharmacodynamics of Artesunate in Pregnant Women in the Democratic Republic of Congo
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
University of North Carolina
Kinshasa School of Public Health
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00538382
First received: September 28, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Malaria |
Drug: Artesunate |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Phase I Study of Pharmacokinetics and Pharmacodynamics of Artesunate in Pregnant Women in the Democratic Republic of Congo |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- 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 (PK parameters = t1/2, Cmax, Tmax, CL/F, Vz/F, AUC). [ Time Frame: 48 hours after drug administration ]
Secondary Outcome Measures:
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Description of safety and tolerability of Artesunate in the target population (pregnant women in the 2nd and 3rd trimester). [ Time Frame: 0ne year postpartum ]
| Estimated Enrollment: | 48 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | March 2009 |
| Arms | Assigned Interventions |
|---|---|
|
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®
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538382
Contacts
| Contact: Linda Wright, M.D. | 301-402-0830 | wrightl@mail.nih.gov |
| Contact: Macaya Douoguih, M.D., M.P.H. | 301-496-7685 | douoguihm@mail.nih.gov |
Locations
| The Democratic Republic of the Congo | |
| Kingasani Maternity Clinic | Recruiting |
| Kinshasa, The Democratic Republic of the Congo | |
| Contact: Marie Onyamboko, M.D. +243 99 00 24 201 akatshimarie@yahoo.fr | |
| Principal Investigator: Antoinette Tshefu, M.D., M.P.H. | |
Sponsors and Collaborators
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
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 |
More Information
Additional Information:
No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00538382 History of Changes |
| Other Study ID Numbers: | GN02- PK/PD of artesunate |
| Study First Received: | September 28, 2007 |
| Last Updated: | September 28, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Malaria Pregnancy Artesunate |
Pharmacokinetics Pharmacodynamics Democratic Republic of Congo |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases Artesunate Amebicides Antiprotozoal Agents |
Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimalarials |
ClinicalTrials.gov processed this record on June 18, 2013