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A Comparison of Diagnostic Approaches for Malaria and Pneumonia

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ClinicalTrials.gov Identifier: NCT02482116
Recruitment Status : Unknown
Verified August 2016 by University of Nottingham.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2015
Last Update Posted : August 31, 2016
Sponsor:
Collaborator:
University of Benin
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
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.

Condition or disease Intervention/treatment
Malaria Pneumonia Other: malaria or pneumonia diagnosis

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : August 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria Pneumonia


Intervention Details:
  • Other: malaria or pneumonia diagnosis
    Diagnostic approaches for malaria (lay diagnosis, as per IMCI guidelines by trained primary healthcare workers, clinical diagnosis by medically qualified doctor, rapid diagnostic tests, Giemsa microscopy); Diagnostic approaches for pneumonia (lay diagnosis, as per IMCI guidelines by trained primary healthcare workers, clinical diagnosis by medically qualified doctor, chest x-ray)
    Other Names:
    • Integrated Management of Childhood Illness (IMCI) guidelines
    • Giemsa microscopy
    • Chest x-ray
    • Rapid diagnostic test for malaria
    • Lay-diagnosis of malaria & pneumonia


Primary Outcome Measures :
  1. Malaria confirmed by microscopy (yes/no) [ Time Frame: 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

  2. Pneumonia confirmed by chest x-ray (yes/no) [ Time Frame: 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


Secondary Outcome Measures :
  1. Hospitalisation (yes/no) [ Time Frame: 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

  2. Death (yes/no) [ Time Frame: 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



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Ages Eligible for Study:   2 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482116


Locations
Nigeria
Health Services Department, University of Benin
Benin City, Edo State, Nigeria
Sponsors and Collaborators
University of Nottingham
University of Benin
Investigators
Principal Investigator: Kelly O Elimian, MSc University of Nottingham & University of Benin
Study Director: Puja R Myles, PhD University of Nottingham
Study Director: Catherine Pritchard, PhD University of Nottingham
Study Director: Ayebo Sadoh, PhD University of Benin

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02482116     History of Changes
Other Study ID Numbers: HA.577/Vol. II/126
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016

Keywords provided by University of Nottingham:
malaria
pneumonia
Nigeria
IMCI
diagnosis

Additional relevant MeSH terms:
Pneumonia
Malaria
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Protozoan Infections
Parasitic Diseases