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- Klinische proef NCT00314899
Fetal Immunity to Falciparum Malaria
Fetal Immunity to Plasmodium Falciparum Malaria
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Nairobi, Kenia
- KEMRI Centre for Geographic Medicine Research
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- At least greater than or equal to 15 years of age.
- Willingness to provide informed consent.
- Confirmed pregnancy.
- Apparent good health.
- Long-term residence in Msambweni locations who anticipate residing in the area during the study period (at least 3 years). Women whose immediate and/or extended families do not reside in Kwale District will be discouraged from enrolling in the study.
- Willingness to donate blood (peripheral venous blood or fingerstick blood as per the protocol) during ANC visits and at the time of delivery.
- Willingness to release human immunodeficiency virus (HIV) testing results from the voluntary counseling and treatment (VCT) program, or be tested by our staff and, if positive, to have their infants tested for HIV at 12 and 24 months of age.
- Willingness of the infant's mother to participate in prenatal and postnatal care at Msambweni District Hospital.
- Willingness of the mother/caregivers to participate in a prospective survey that involves bi-annual venipuncture (3-5 mL blood volume) of the infant commencing at 6 months (plus or minus 2 months of age) and ending at age 36 months.
- Multiple births can be included.
Pregnant women will be allowed to enroll irrespective of their gestational age, although they cannot enroll at delivery because they cannot undergo adequate consent. However, potential participants will be strongly encouraged to come to the clinic for prenatal care early in the second trimester (ideally <16 weeks gestation) both to ensure adequate prenatal care for the mother and unborn infant and to provide sufficient follow-up time to collect multiple antenatal study samples from the mother.
Inclusion criteria for American participants: Participants must be in good health, between the ages of 18 to 65, and have never been exposed to malaria.
Inclusion criteria for Kenyan control subjects: Participants must be in general good health and either have been exposed to malaria or be infected with malaria, but asymptomatic. Exposure will be determined by the presence of antibodies to malarial blood-stage antigens, eg, MSP1-42. Subjects must be aged 18 to 55 years, inclusive.
Exclusion Criteria:
- Preterm delivery less than 34 weeks gestation.
- Failure to deliver in the hospital.
- Evidence of placenta previa.
- Maternal chorioamnionitis.
- Receipt of immunosuppressive drugs during pregnancy.
- Hemoglobin less than 6.07 g/dL for females*.
- More One plus or greater glucose in urine.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding enrollment in the study.
- Simultaneous participation in any other interventional clinical trial.
- Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, or any other findings that in the opinion of the CO or PI may increase the risk of participating in the study.
Other conditions that in the opinion of the CO or PI would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.
- These values may change base on survey of adult normal laboratory test values in Msambweni. Values for children will be revised based on a survey of pediatric normal values in Msambweni.
Censoring events for the mother and newborn (and, by default, the infant's mother):
- Mother delivers elsewhere, migrates out of area, dies, spontaneous abortion or stillbirth.
- APGAR score for the infant of less than 5 at 10 minutes after birth.
- Muconium aspiration, respiratory distress syndrome, or condition to require neonatal resuscitation.
- Extremely low birth weight (less than 1500 grams).
- Refuse to continue to participate in the study.
Participants who move outside the study area during the course of the study will be dropped from further participation. However, data collected to that point may be included in analysis.
Exclusion of American and Kenyan control subjects:
No prior screening will be performed for the American control subjects, other than that they state they are healthy and have no acute or chronic medical problems. For the Kenyan adult control subjects, they will also be queried about their general overall perceived health and will have no known acute or chronic illnesses. A FSB sample will be obtained from the Kenyan control subjects and tested for anti-bodies to MSP142, a blood smear for malaria, and hemoglobin concentration by Hemacue test. If the hemoglobin concentration is <10 gm/dL, the subject will not be asked to donate blood and will be referred to the appropriate health care deliverers to receive appropriate treatment (oral iron supplements).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 05-0074
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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Novartis PharmaceuticalsWervingOngecompliceerde Plasmodium Falciparum MalariaIvoorkust, Kenia, Ghana, Oeganda
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University of OxfordEuropean and Developing Countries Clinical Trials Partnership (EDCTP); Medical...WervingMalaria, Plasmodium FalciparumGambia
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Syamsudin Abdillah,Ph.D, Pharm DApt. Dian Yudianto; Dr. dr Erni J. Nelwan, Sp.PD, Ph.D; Apt.Hesty Utami Ramadaniati...VoltooidOngecompliceerde Plasmodium FalciparumIndonesië
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PfizerVoltooid
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Muhimbili University of Health and Allied SciencesUppsala University; The Swedish Research CouncilNog niet aan het wervenOngecompliceerde Plasmodium Falciparum MalariaTanzania
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Novartis PharmaceuticalsEuropean and Developing Countries Clinical Trials Partnership (EDCTP)WervingOngecompliceerde Plasmodium Falciparum MalariaBurkina Faso, Mali, Gabon