A Comparison of Diagnostic Approaches for Malaria and Pneumonia

NCT02482116 | Unknown

• 1 other identifier: HA.577/Vol. II/126
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria; Pneumonia

Keywords

malaria; pneumonia; Nigeria; IMCI; diagnosis

Outcome Measures

Primary Outcomes (2)

• Malaria confirmed by microscopy (yes/no)

  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)

  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

Secondary Outcomes (2)

• Hospitalisation (yes/no)

  Within 30 days of first consultation

• Death (yes/no)

  Within 30 days of first consultation

Interventions

malaria or pneumonia diagnosis OTHER

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)

Also known as: Integrated Management of Childhood Illness (IMCI) guidelines, Giemsa microscopy, Chest x-ray, Rapid diagnostic test for malaria, Lay-diagnosis of malaria & pneumonia

Eligibility Criteria

• Age: 2 Months - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• University of Nottingham: lead
• University of Benin: collaborator

Study Sites (1)

Health Services Department, University of Benin

Benin City, Edo, Nigeria

Location

MeSH Terms

Conditions

Malaria; Pneumonia; Disease

Interventions

Guidelines as Topic; X-Rays; Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management

Study Officials

• Kelly O Elimian, MSc

  University of Nottingham & University of Benin

  PRINCIPAL INVESTIGATOR

• Puja R Myles, PhD

  University of Nottingham

  STUDY DIRECTOR

• Catherine Pritchard, PhD

  University of Nottingham

  STUDY DIRECTOR

• Ayebo Sadoh, PhD

  University of Benin

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 26, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

NG (1)