NCT02946775

Brief Summary

To define the etiologic agents of community acquired bacteremic syndromes (defined as septicemia, bacteremia, pneumonia and/or meningitis) in a malaria endemic setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29,146

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

5.8 years

First QC Date

December 1, 2014

Last Update Submit

September 27, 2023

Conditions

Community-Acquired Infections

Keywords

septicemiabacteremiapneumoniameningitis

Outcome Measures

Primary Outcomes (1)

  • Bacterial infections in children

    Prevalence of bacterial infections in children identified through analysis of blood culture.

    10 years

Eligibility Criteria

Age1 Minute - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric subjects 0-14 years of age

You may qualify if:

  • Children 0-14 years of age presenting with an acute febrile illness with a temperature of more than or equal to 38 degrees C or hypothermia (temperature less than 36 degrees C) with any of the following symptoms; convulsion, respiratory distress, prostration or non-traumatic circulatory collapse to the pediatric outpatient or emergency pediatric units of participating Nigerian institutions.

You may not qualify if:

  • No consent obtained/withdrawal of consent, known congenital heart disease, bronchial asthma, or recent hospitalizations within the past 2 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nigerian health clinics

Abuja, Nigeria

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, stool, nasopharyngeal swab/aspirate as well as cerebrospinal fluid (CSF), pleural fluid, induced sputum, gastric aspirates or synovial fluid with clinical indication.

MeSH Terms

Conditions

Community-Acquired InfectionsSepsisBacteremiaPneumoniaMeningitis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial InfectionsBacterial Infections and MycosesRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesNeuroinflammatory DiseasesNervous System Diseases

Study Officials

  • Stephen K Obaro, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2014

First Posted

October 27, 2016

Study Start

September 13, 2012

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations

NG(1)