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NCT03052088: AutoPilot

Diagnostic Accuracy of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients

Completed Last updated 12 October 2021
What this trial tests

trial in Fever in 1,140 participants. Completed in 1 August 2019.

Timeline
6 February 2017
Primary endpoint
1 June 2019
1 August 2019

Quick facts

Lead sponsorMeMed Diagnostics Ltd.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,140
Start date6 February 2017
Primary completion1 June 2019
Estimated completion1 August 2019
Sites2 locations across Italy, Germany

Conditions studied

Sponsor

MeMed Diagnostics Ltd.

Who can join

3 Months and older, any sex, with Fever or Respiratory Tract Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective clinical validation study of a novel regulatory approved (CE-IVD) diagnostic assay called ImmunoXpert™ that will enroll 1222 pediatric patients. The study aims to externally validate the tool's diagnostic accuracy and estimate the potential improvement in health and economic outcomes following the usage of ImmunoXpert™. Additionally, statistical analysis will be performed to compare ImmunoXpert™ accuracy to current practice lab testing (e.g. WBC, CRP, and PCT) and clinical suspicion at time of requisition. Enrolled patients will be managed according to the current standard of care and per standard institutional procedures.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Community-Acquired Pneumonia in Children: the Challenges of Microbiological Diagnosis.
    Rodrigues CMC, Groves H. · · 2018 · cited 62× · PMID 29237789 · DOI 10.1128/jcm.01318-17
  2. Development of a Reference Standard to Assign Bacterial Versus Viral Infection Etiology Using an All-inclusive Methodology for Comparison of Novel Diagnostic Tool Performance.
    Allen C, Deanehan JK, Dotan Y, Eisenberg MA, et al · · 2025 · cited 8× · PMID 39750735 · DOI 10.1093/cid/ciae656
  3. 75th Congress of the Italian Society of Pediatrics : Bologna, Italy. 29 May - 1 June 2019.
    · 2019 · cited 1× · PMID 31849329 · DOI 10.1186/s13052-019-0746-3
  4. 2242. Use of a Procalcitonin Assay in Hospitalized Patients for CHF Reduced Subsequent Use of Antibiotics
    Majeed I, Levine Z, Szpunar S. · · 2019
  5. 2240. Can Antibiotic Duration Be Reduced by the Sequential Use of Procalcitonin and Endotoxin in Patients with Sepsis? A Prospective Double-Blind Clinical Trial
    Kalil A, Florescu D, Shafer L, Van Schooneveld T. · · 2019
  6. 2239. Randomized Controlled Trial of a PROcalcitonin-Guided Antibiotic Treatment Algorithm Plus Antibiotic Stewardship the Pediatric Intensive Care Unit (ProPICU)
    Katz S, Crook J, Gillon J, Szeles A, et al · · 2019
  7. 1960. Antibiotic Challenge Dose Testing Improves Patient Care and Lowers Costs in a Community Hospital: A 2-Year Prospective Study
    Lambl B, Reyes-Dassum S, Oommen V, Dike O, et al · · 2018
  8. 1959. Ceftriaxone-Sulbactam-EDTA (CSE) vs. Meropenem (MR) in PLEA (a Phase 3, Randomized, Double-Blind Trial): Outcomes in Patients Infected With Ceftriaxone Non-Susceptible, Extended-Spectrum β-Lactamase and Multi-Drug-resistant Pathogens at Baseline
    Mir M, Chaudhary S, Mammen K, Sood R, et al · · 2018

Verify or expand the search:

Other recruiting trials for Fever

Currently open trials in the same condition.

Other MeMed Diagnostics Ltd. trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03052088.

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