Malaria Incidence in Infants in Bancoumana, Mali
30. juni 2017 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)
This study, conducted by the Malaria Research and Training Center at the Faculty of Medicine in Bamako and the NIAID will measure the frequency of occurrence of malaria in infants in Bancoumana, Mali. Information from the study will help in planning trials of malaria vaccines.
Healthy children from 6 weeks to 6 months of age who live in the Bancoumana health area may be eligible for this study. Candidates are screened with a physical examination and blood tests.
Participating children are visited at home for a total of about 17 visits to see if they are well. They come to the clinic every month during the 7-month study for a clinical evaluation, including a blood sample obtained by finger prick to test for malaria. Some of the blood collected may be stored and used for research. Children who become sick with malaria are treated for the disease.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
This is an observational study to determine the burden of malaria in rural Malian infants.
Infants will be identified during a village-wide census and at Expanded Program for Immunization (EPI) visits.
After obtaining community consent, eligible infants' parents will be invited to bring infants to the clinic for screening.
Enrolled infants will receive a baseline evaluation and monthly visits during the rainy season at which times they will receive interim evaluations and heel, toe, or finger pricks for determinations of hemoglobin, thick and thin blood films, malaria antibody titers (at first and last visit for each transmission season), and hemoglobin typing at one visit.
Study subjects will also receive a weekly home visit to determine if they are well or ill.
If ill or febrile at any visit, or if they present to the clinic for an unscheduled visit, subjects will receive a history and physical examination, heel, toe, or finger pricks for determinations of hemoglobin, thick and thin blood films, filter paper blood collection and an RDT for malaria.
Diagnosis and treatment of malaria will be performed according to Mali National Malaria Control Program (NMCP) guidelines.
Diagnosis and treatment of other conditions will be performed as determined by the treating clinician.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
600
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Maryland
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Bethesda, Maryland, Forenede Stater, 20892
- National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 måned til 6 måneder (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
INCLUSION CRITERIA:
- Infants at least six weeks to less than 7 months of age at enrollment
- Known residents of the Bancoumana health area
- Good general health as determined by clinical exam
- Available for the 6-7 months duration of the trial
- Willingness to participate as evidenced by signing of the informed consent or fingerprinting by the parent or guardian
EXCLUSION CRITERIA:
- Social, behavioral, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the volunteer or the parent/legal guardian to understand and cooperate with the study protocol
- Participation in an investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing
- Infant born to mother with known or suspected HIV/AIDS as determined by the clinician
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tidsperspektiver: Fremadrettet
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Duflo B, Balique H, Ranque P, Diallo AN, Brucker G, Alavi H, Prescott N. [Estimation of the impact of the principal diseases in rural Mali]. Rev Epidemiol Sante Publique. 1986;34(6):405-18. French.
- Wagner G, Koram K, McGuinness D, Bennett S, Nkrumah F, Riley E. High incidence of asymptomatic malara infections in a birth cohort of children less than one year of age in Ghana, detected by multicopy gene polymerase chain reaction. Am J Trop Med Hyg. 1998 Jul;59(1):115-23. doi: 10.4269/ajtmh.1998.59.115.
- Moody AH, Chiodini PL. Non-microscopic method for malaria diagnosis using OptiMAL IT, a second-generation dipstick for malaria pLDH antigen detection. Br J Biomed Sci. 2002;59(4):228-31. doi: 10.1080/09674845.2002.11783665.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
24. juli 2007
Studieafslutning
11. februar 2011
Datoer for studieregistrering
Først indsendt
27. juli 2007
Først indsendt, der opfyldte QC-kriterier
27. juli 2007
Først opslået (Skøn)
30. juli 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juli 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juni 2017
Sidst verificeret
11. februar 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 999907198
- 07-I-N198
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .