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A Comparison of Diagnostic Approaches for Malaria and Pneumonia

30. august 2016 opdateret af: University of Nottingham

Malaria and Pneumonia in Children Under the Age of Five Years Old Presenting to Primary Healthcare Centres in Benin City, Nigeria: a Comparison of Early Diagnostic Approaches

This research investigates the diagnostic accuracy of various diagnostic approaches for malaria and pneumonia in under-five children presenting to primary healthcare centres in Benin City, Nigeria.

Studieoversigt

Status

Ukendt

Intervention / Behandling

Detaljeret beskrivelse

Of the preventable and treatable diseases, both malaria and pneumonia are significant contributors to under-five mortality in Nigeria. To reduce the burden of these diseases, the Integrated Management of Childhood Illness (IMCI) guidelines were developed by the World Health Organisation (WHO) to be used at first point of contact (e.g., primary healthcare centres) with children under the age of five years old. Preliminary literature review suggests that although interventions based on numerous diagnostic approaches have been trialed, burden from malaria and pneumonia remains unacceptably high in Nigeria, suggesting limited effectiveness of existing approaches. Therefore, this study aims to compare the accuracy of different early diagnostic approaches used in the community(for e.g. the WHO Integrated Management of Childhood Illness (IMCI) guidelines versus the gold standard diagnostic tests comprising microscopy in malaria and chest radiography in pneumonia) in children under the age of five years presenting with suspected malaria and pneumonia to primary healthcare centres in Benin City, Edo State of Nigeria.

The research will compare the accuracy of these various diagnostic approaches using measures such as sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve. The research will also assess patient outcomes like complications, hospitalisation and death following a diagnosis of either pneumonia or malaria in all study participants as well as costs associated with malaria and pneumonia.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Edo State
      • Benin City, Edo State, Nigeria
        • Health Services Department, University of Benin

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 år til 2 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population are children aged 2 months to four years old who are residents in the catchment local government area of study primary healthcare centres in Benin City, Edo State, Nigeria.

Beskrivelse

Inclusion Criteria:

  • Suspected malaria (symptoms reported by caregiver that are consistent with malaria: high temperature, chills and no other probable diagnosis)
  • Suspected pneumonia (fever, cough, shortness of breath/difficulty in breathing, with or without chills and no other probable diagnosis)
  • Willingness of caregiver to provide written or verbal consent in the presence of a witness.

Exclusion Criteria:

None

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Malaria confirmed by microscopy (yes/no)
Tidsramme: Participants will be assessed within an average period of 24 hours of presenting to study primary healthcare centres
This is the gold standard diagnosis for malaria and will be used to assess the accuracy of other diagnostic approaches
Participants will be assessed within an average period of 24 hours of presenting to study primary healthcare centres
Pneumonia confirmed by chest x-ray (yes/no)
Tidsramme: Participants will be assessed within an average period of 48 hours of presenting to study primary healthcare centres
This is the gold standard test for pneumonia and will be used to assess the accuracy of other diagnostic approaches
Participants will be assessed within an average period of 48 hours of presenting to study primary healthcare centres

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hospitalisation (yes/no)
Tidsramme: Within 30 days of first consultation
This will be assessed for all study participants with either a malaria or pneumonia diagnosis as part of an epidemiological study
Within 30 days of first consultation
Death (yes/no)
Tidsramme: Within 30 days of first consultation
This will be assessed for all study participants with either a malaria or pneumonia diagnosis as part of an epidemiological study
Within 30 days of first consultation

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Kelly O Elimian, MSc, University of Nottingham & University of Benin
  • Studieleder: Puja R Myles, PhD, University of Nottingham
  • Studieleder: Catherine Pritchard, PhD, University of Nottingham
  • Studieleder: Ayebo Sadoh, PhD, University of Benin

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

1. august 2015

Primær færdiggørelse (Forventet)

1. juli 2017

Studieafslutning (Forventet)

1. juli 2017

Datoer for studieregistrering

Først indsendt

22. juni 2015

Først indsendt, der opfyldte QC-kriterier

25. juni 2015

Først opslået (Skøn)

26. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

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 Lungebetændelse

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