|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00486863 |
Purpose
The purpose of the study is to understand whether the drug praziquantel (PZQ) is safe for the mother and developing baby when the mother has schistosomiasis (a type of worm) infection, and whether the drug may improve the mother's and baby's health. The usual practice is to wait until after a mother has finished breast feeding before giving the medicine. Five hundred infected pregnant women, ages 18 and over, in endemic villages in Leyte, The Philippines will participate. Study volunteers 12-16 weeks pregnant will be given PZQ or a pill without any medicine (placebo) and stay in the hospital overnight. Small blood samples will be collected before and after the medication is taken. Three stool and urine samples will be taken during a total of 7 study visits. An ultrasound image (picture or outline of the unborn baby) will be performed. When the baby is born, a small blood sample will be taken. Mother and baby will be followed for up to 8 months before the baby is born and 1 month after.
| Condition | Intervention | Phase |
|---|---|---|
|
Schistosomiasis [Bilharziasis] |
Drug: Placebo Drug: Praziquantel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | S. Japonicum and Pregnancy Outcomes: A Randomized, Double Blind, Placebo Controlled Trial (RCT) |
| Estimated Enrollment: | 1000 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Praziquantel: Experimental
Praziquantel at 12-16 weeks gestation.
|
Drug: Praziquantel
60 mg/kg administered orally given in split dose (30/mg/kg each) separated by at least 3 hours; gel encapsulated with 2 different color capsules.
|
|
Control: Placebo Comparator
Placebo at 12-16 weeks gestation.
|
Drug: Placebo
Inert compound dextrose, gel encapsulation.
|
This double-blind, placebo-controlled study will investigate praziquantel (PZQ) for the treatment of Schistosomiasis japonicum in pregnant women living in endemic villages of Leyte, The Philippines. The study will enroll 500 pregnant women, ages 18 and over, infected with S. japonicum. The primary study objective is to quantify the efficacy of PZQ treatment for S. japonicum at 12-16 weeks gestation on newborn birth weight among live births. This will be assessed by measuring birth weight within 96 hours of delivery to 10 grams. The first secondary objective is to assess treatment efficacy with respect to maternal and newborn nutritional status and maternal parasitologic response to treatment. This will be assessed by evaluating: maternal iron status (ferritin and serum transferrin receptor) and hemoglobin at 32 weeks gestation; change in maternal nutritional status from first trimester to 32 week visit; newborn iron stores as assessed by cord blood ferritin and hemoglobin; and parasitologic response to treatment reported as percent reduction in egg counts from the mean S. japonicum eggs per gram of stool at screening to the mean S. japonicum eggs per gram of stool at 22 weeks gestation. "Successful" treatment will be defined as a 90% or greater reduction in egg counts from pre-treatment to 22 weeks gestation. The second secondary objective is to collect preliminary safety and toxicity data on use of PZQ among pregnant women and their newborns. This will be assessed by evaluating: incidence of maternal convulsion after PZQ dosing; toxicity to maternal bone marrow, kidney, and liver as measured by laboratory parameters collected just before, and 24-48 hours after dose; immediate toxicity to the fetus as assessed by abortion (fetal demise before 20 weeks gestation); and long-term toxicity to the fetus as assessed by rates of pre-maturity measured by modified Dubowitz exam at delivery, low-birth weight, stillbirth as defined by fetal demise after 20 weeks gestation, congenital anomalies as determined by physical exam performed by a pediatrician at 28 days of life; and pharmacokinetics of PZQ during pregnancy as assessed by 2 blood draws (4.5 and 8 hours after the first dose or 6 and 10 hours after the first dose). The third secondary objective is to identify extra-placental mechanisms mediating the hypothesized beneficial effect of PZQ on birth outcomes. The hypothesized mechanisms include: improved maternal iron bio-availability for transfer to the developing fetus and improved maternal nutritional status as assessed by anthropometric measures of body size. The fourth secondary objective is to identify extra-placental mechanisms mediating the hypothesized beneficial effect of PZQ on birth outcomes. The hypothesized mechanisms include: decreased concentrations of tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma, and interleukin (IL)-6 and increased concentrations of IL-10 compared in placental blood from S. japonicum infected, PZQ treated mothers compared to untreated mothers; decreased secretion of TNF-alpha, IFN-gamma, and IL-6 and more IL-10 secretion from placental explants from S. japonicum infected, PZQ treated women when stimulated with soluble parasite egg antigen compared to placental explants from S. japonicum infected, PZQ untreated mothers; and lower level of apoptosis in cultured trophoblasts exposed to peripheral serum as measured by cytokeratin 18 neo-epitope staining among S. japonicum infected, PZQ treated mothers versus untreated mothers. Participants will be involved in study related procedures for 9 months (8 months pre-natally and 1 month post-natally) for mother and infant.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For screening:
For the main study:
Exclusion Criteria:
Presence of significant disease/illness that is either acute or chronic. This will be defined by history, physical examination, ultrasound and laboratory assessment. In particular:
Contacts and Locations
More Information
| Responsible Party: | HHS/NIAID/DMID ( Robert Johnson ) |
| Study ID Numbers: | 06-0039 |
| Study First Received: | June 14, 2007 |
| Last Updated: | November 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00486863 History of Changes |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration; Philippines: Institutional and Ethical Review Board; Philippines: Department of Health; United States: Institutional Review Board |
|
Philippines, Schistosoma japonicum, Schistosomiasis, pregnant women |
|
Anti-Infective Agents Trematode Infections Antiparasitic Agents Therapeutic Uses Schistosomiasis |
Anthelmintics Praziquantel Parasitic Diseases Helminthiasis Pharmacologic Actions |