MalariaNCT02482116
A Comparison of Diagnostic Approaches for Malaria and Pneumonia
An observational study of Malaria and Pneumonia, run by University of Nottingham at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 4 years
- What is being tested?
- malaria or pneumonia diagnosis
- How many people
- 1,000 participants
- Where
- 1 siteNigeria
- Study dates
- Aug 2015to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 4 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- malaria or pneumonia diagnosis
- Keywords
- malaria, pneumonia, Nigeria, IMCI, diagnosis
- Medical subject headings
- Malaria, Pneumonia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
malaria or pneumonia diagnosisOther
Also called Integrated Management of Childhood Illness (IMCI) guidelines, Giemsa microscopy, Chest x-ray, Rapid diagnostic test for malaria
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Participants will be assessed within an average period of 48 hours of presenting to study primary healthcare centres
Secondary outcomes (2)
Hospitalisation (yes/no)
This will be assessed for all study participants with either a malaria or pneumonia diagnosis as part of an epidemiological study
Measured: Within 30 days of first consultation
Death (yes/no)
This will be assessed for all study participants with either a malaria or pneumonia diagnosis as part of an epidemiological study
Measured: Within 30 days of first consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Benin
- Responsible party
- Sponsor
- Investigators
- Kelly O Elimian, MSc, Principal investigator, University of Nottingham & University of BeninPuja R Myles, PhD, Study director, University of NottinghamCatherine Pritchard, PhD, Study director, University of NottinghamAyebo Sadoh, PhD, Study director, University of Benin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482116
- Sponsor's protocol ID
- HA.577/Vol. II/126
- Status last verified
- Aug 2016
- First submitted
- 22 Jun 2015
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02482116
- Acronym / sponsor ID
- HA.577/Vol. II/126
- Keywords
- malaria, pneumonia, Nigeria, IMCI, diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University of Benin
- Study start
- Aug 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| malaria or pneumonia diagnosisAlso: Integrated Management of Childhood Illness (IMCI) guidelines, Giemsa microscopy, Chest x-ray, Rapid diagnostic test for malariaDiagnostic 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 | – |
Primary outcome
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
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
2 secondary outcomes
Hospitalisation (yes/no)
Time frame: Within 30 days of first consultation
Death (yes/no)
Time frame: Within 30 days of first consultation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly O Elimian, MSc principal investigator
University of Nottingham & University of Benin
Puja R Myles, PhD study director
University of Nottingham
Catherine Pritchard, PhD study director
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Pneumonia, run by University of Nottingham at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.