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NCT03996967 · ClinicalTrials.gov registry record
Diagnostic and Prognostic Biomarkers for Childhood Bacterial Pneumonia
A clinical trial, sponsored by Boston University.
- Completed
- Registry status
- 837
- Enrollment target
NCT03996967: Completed study, sponsored by Boston University.
NCT03996967 is a clinical trial that has completed, run by Boston University. The registered enrollment target is 837 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03996967 has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- 837 participants
- Enrollment target
Study Summary
Clinical pneumonia is a leading cause of pediatric hospitalization. The etiology is generally bacterial or viral. Prompt and optimal treatment of pneumonia is critical to reduce mortality. However, adequate pneumonia management is hampered by: a) the lack of a diagnostic tool that can be used at point-of-care (POC) and promptly and accurately allow the diagnosis of bacterial disease and b) lack of a prognostic POC test to help triage children in need of intensive assistance. Antibiotic therapy is frequently overprescribed as a result of suspected bacterial infections resulting in development of antibiotic resistance. Conversely, in malaria-endemic areas, antibiotics may also be "underprescribed" and children with bacterial pneumonia sent home without antibiotic therapy, when the clinical pneumonia is mistakenly attributed to a co-existing malaria infection. The investigators previously identified combinations of protein with 96% sensitivity and 86% specificity for detecting bacterial disease in Mozambican children with clinical pneumonia. The investigators' prior work showed that it is possible to identify biosignatures for diagnosis and prognosis using few proteins. Recently, other authors also identified different accurate biosignatures (e.g., IP-10, TRAIL and CRP). In this study, the investigators propose to validate and improve upon previous biosignatures by testing prior combinations and seeking novel combinations of markers in 900 pediatric inpatients aged 2 months to 5 years with clinical pneumonia in The Gambia. The investigators will also use alternative case criteria and seek diagnostic and prognostic combination of markers. This study will be conducted in Basse, rural Gambia, in two hospitals associated with the Medical Research Council Unity The Gambia (MRCG). Approximately 900 pediatric patients with clinical pneumonia aged 2 months to 5 years of age will be enrolled. Patients will undergo standard of care test and will have blood proteins measured th
Primary Outcome
A patient will be assigned to the bacterial (BA) group if he/she has a bacterial pathogen culture of fluid from a normally sterile site (e.g. blood, pleural fluid). Patients will be assigned to the viral (VI) group if they have negative bacteria microbiological tests, negative malaria blood slides, X-ray without "endpoint pneumonia" (consolidation or pleural effusion50), no evidence of fungal infection, and positive PCR for a viral pathogen from nasopharyngeal swabs. Patients will be assigned to
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 837 participants |
| Start Date | 2019-02-11 |
| Est. Completion | 2021-04-10 |
What the finished NCT03996967 record still lists
NCT03996967 is an observational study that tracks outcomes without assigning an intervention. The registered 837 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT03996967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03996967 about?
NCT03996967 is a clinical study titled "Diagnostic and Prognostic Biomarkers for Childhood Bacterial Pneumonia". Clinical pneumonia is a leading cause of pediatric hospitalization. The etiology is generally bacterial or viral. Prompt and optimal treatment of pneumonia is critical to reduce mortality. However, adequate pneumonia management is hampered by: a) the lack of a diagnostic tool that can be used at poi...
What is the current status of trial NCT03996967?
This trial is currently completed. The enrollment target is 837 participants. The study started on 2019-02-11. Estimated completion is 2021-04-10.
Who is sponsoring clinical trial NCT03996967?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
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