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NCT03996967
Diagnostic and Prognostic Biomarkers for Childhood Bacterial Pneumonia
trial in Pneumonia, Bacterial in 837 participants. Completed in 10 April 2021.
10 April 2021
Quick facts
| Lead sponsor | Boston University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 837 |
| Start date | 11 February 2019 |
| Primary completion | 10 April 2021 |
| Estimated completion | 10 April 2021 |
| Sites | 3 locations across The Gambia, Netherlands, United States |
Conditions studied
- Pneumonia, Bacterial — all drugs for Pneumonia, Bacterial →
- Viral Infection — all drugs for Viral Infection →
- Clinical Pneumonia — all drugs for Clinical Pneumonia →
- Plasmodium Falciparum Malaria — all drugs for Plasmodium Falciparum Malaria →
Sponsor
Boston University
Who can join
Adults 2 Months to 5, any sex, with Pneumonia, Bacterial or Viral Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 through Luminex®-based immunoassays. Results of this study may ultimately support future development of an accurate point-of-care test for bacterial disease to guide clinicians in choices of treatment and to assist in the prioritization of intensive care in resource-limited settings.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03996967
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Related trials
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Currently open trials in the same condition.
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- NCT06238297 — Rapid De-escalation of Anti-MRSA Therapy Guided by S. Aureus Nares Screening in Case of Pneumonia · NA · recruiting
- NCT05776004 — Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia · Phase 2 · active not recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03996967 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boston University
- Last refreshed: 31 May 2022
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