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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02734186 |
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Date of registration:
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06/04/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Concomitant Mansonella Perstans Microfilaremia on Immune Responses Following Single Dose Praziquantel in People With Schistosomiasis
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Scientific title:
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Effect of Concomitant Mansonella Perstans Microfilaremia on Immune Responses Following Single Dose Praziquantel in Subjects With Schistosomiasis: A Pilot Study |
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Date of first enrolment:
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April 6, 2016 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02734186 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Mali
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Contacts
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Name:
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Amy D Klion, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Allergy and Infectious Diseases (NIAID) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA (SCREENING):
1. Male or non-pregnant female subjects
2. Age 14-80 years (per participant self-report)
3. Resident of Tienegubougou, Bougoudiana or surrounding villages
5. Consent to a blood draw to screen for filarial infection and a urine exam to screen
for schistosomiasis
6. Must be willing to have blood samples stored.
EXCLUSION CRITERIA (SCREENING):
1. Known to be pregnant (by history)
2. Chronic medical conditions, including but not limited to diabetes, renal or hepatic
insufficiency, immunodeficiency, psychiatric disorder, seizure, that in the
investigators judgments are deemed to be clinically significant
3. History of hypersensitivity reaction to PZQ.
4. Weight less than 20 kg
INCLUSION CRITERIA (INTERVENTIONAL STUDY):
1. S. haematobium infection documented at screening and within 14 days prior to the
baseline visit
2. The subject agrees to storage of samples for study.
EXCLUSION CRITERIA (INTERVENTIONAL STUDY):
1. Pregnancy (by urine beta-HCG)
2. Chronic kidney or liver disease
3. Hgb <10 mg/dL
4. PZQ treatment since the screening visit
5. Concomitant Schistosoma mansoni, Wuchereria bancrofti (Wb) or Onchocerca volvulus
infection
6. Use of immunosuppressive therapies, including steroids, within the past month
7. Any condition that in the investigator s opinion places the subject at undue risk by
participating in the study.
EXCLUSION OF CHILDREN AND PREGNANT WOMEN:
Pregnant women will be excluded from this study since it involves administration of
medications contraindicated in pregnancy. Children less than 14 years old will be excluded
because of the amount of blood required for the immunologic studies. The age of consent in
Mali is 18 years of age, so children aged 14 to 17 years will sign an assent form in
addition to the consent form to be signed by a parent or tutor. However, married women
between the ages of 14 and 17 will sign consent as adults in view of the laws governing
emancipation of women in Mali. Subjects who do not participate in this study will receive
PZQ as part of the national schistosomiasis control program.
Participation of Women:
-Pregnancy: The effects of praziquantel on the developing human fetus are unknown
(pregnancy category B). For this reason, females of
childbearing-age must have a negative pregnancy test result prior to receiving
praziquantel. Since the half-life of praziquantel is short (3-4 hours), contraceptive
measures will not be required post-treatment.
-Breast feeding: Praziquantel is known to be present in breast milk for up to 3 days
following a single dose and is not approved for use in children under the age of 4 years.
Consequently, women will be asked to suspend breastfeeding after treatment with PZQ for 3
days. Formula will be provided for breastfed children affected by their mother s
participation during this time to ensure adequate nutrition. Depending on the age of the
child, formula may be given. A pediatric nurse will be present during this time to provide
assistance and counsel to the mothers.
Age minimum:
14 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Schistosomiasis
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Intervention(s)
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Drug: Praziquantel
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Primary Outcome(s)
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Peak percentage change from baseline eosinophil count
[Time Frame: During the first 7 days post-treatment]
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Secondary Outcome(s)
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Number of subjects with detectable Sh eggs in urine
[Time Frame: At 1, 3 and 6 months post-treatment]
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Peak absolute change from the baseline eosinophil count and peakpercentage change in eosinophil granule protein levels
[Time Frame: During the first 7 days post-treatment]
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Frequency and severity of adverse events
[Time Frame: During the first 3 days post-treatment]
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Secondary ID(s)
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16-I-N084
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999916084
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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