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Malawi International Center of Excellence in Malaria Research School-based Cohort

22. april 2021 opdateret af: Miriam Laufer, University of Maryland, Baltimore

Epidemiology of Malaria in Malawi: Human Hosts and Parasites in Three Districts Part 2: Cross-sectional Surveillance (School-based Cohorts)

A school-based, prospective, cohort study was conducted to evaluate the epidemiology of P. falciparum (Pf) infections in school-age children and determine the impact of the screen-and-treat approach on Pf infection and anemia prevalence among students in two different transmission settings. Investigators aimed to evaluate how frequently malaria rapid diagnostic tests (mRDTs) fail to detect low-parasite-density infections as well as whether low-density infections contribute to the burden and health consequences of Pf infection in school-age children and whether they contain gametocytes, the parasite stage required for transmission from humans to mosquitos.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Students were enrolled in four schools in southern Malawi in the rainy (March-May) and dry season (Sept-Nov) of 2015. 15 students per grade-level (grades 1-8), were invited to participate. Following enrollment, students were evaluated at baseline for screening-and-treatment, and followed-up 1, 2 and 6 weeks later. At each follow-up visit, a blood sample was obtained for microscopy and molecular detection of parasites and students were interviewed about bed net use the night prior, current or recent illness, and use of antimalarial treatment. At the final visit, a mRDT and hemoglobin test were repeated, and parents were interviewed and portable medical records ("health passports") were reviewed to identify intercurrent fever or malaria treatment.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

786

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

5 år til 15 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

15 students per grade (1 through 8) were randomly sampled in four primary schools

Beskrivelse

Inclusion Criteria:

  • Randomly selected student at a participating school

Exclusion Criteria:

  • Parent or guardian not available for consent
  • Age <5 or >= 16 years
  • Known allergy or adverse reaction to lumefantrine-artemether
  • Child will not attend this school during the time of the survey
  • For the dry season survey (Sept-Oct 2015), participants in the rainy season survey (April-May 2015)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
All students
All participating students were screened for Pf infection using malaria rapid diagnostic tests (mRDTs) and treated if positive. All were followed 1, 2, and 6 weeks after screening-and-treatment.
Andet: Screening and treatment
Students were screened by mRDTs and treated with artemether-lumefantrine if positive
Andre navne:
  • mRDTs: Paracheck Orchid Biomedical Systems or SD Bioline, Standard Diagnostics Inc.; treatment with artemether-lumefantrine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
P. falciparum infection
Tidsramme: 6 weeks after screening
Any stage Pf infection detected by quantitative polymerase chain reaction (PCR)
6 weeks after screening
P. falciparum gametocyte presence
Tidsramme: 6 weeks after screening
Pfs25 quantitative reverse transcriptase PCR
6 weeks after screening
P. falciparum gametocyte density
Tidsramme: 6 weeks after screening
Pfs25 quantitative reverse transcriptase PCR
6 weeks after screening

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Microscopic P. falciparum infection
Tidsramme: 6 weeks after screening
Pf infection detected by microscopy
6 weeks after screening
Anemia
Tidsramme: 6 weeks after screening
Hb measured by Hemocue and categorized using WHO age and gender specific values
6 weeks after screening

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Maryland, Baltimore

Samarbejdspartnere

National Institute of Allergy and Infectious Diseases (NIAID)
Michigan State University
Kamuzu University of Health Sciences

Efterforskere

  • Ledende efterforsker: Miriam Laufer, MD, University of Maryland, Baltimore

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

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 (Faktiske)

24. marts 2015

Primær færdiggørelse (Faktiske)

13. november 2015

Studieafslutning (Faktiske)

13. november 2015

Datoer for studieregistrering

Først indsendt

14. april 2021

Først indsendt, der opfyldte QC-kriterier

22. april 2021

Først opslået (Faktiske)

26. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HP-00052129
  • U19AI089683 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

data will be available via a publicly available database, such as ClinEpiDB

IPD-delingstidsramme

After results publication

IPD-delingsadgangskriterier

Public access with registration to allow tracking

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

Kliniske forsøg med Anæmi

Kliniske forsøg med Screening and treatment

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Poland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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