Molecular culture for diagnosing sepsis in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to improve the diagnosis of sepsis in newborns and children by utilizing a molecular culture method. Currently, blood cultures take 36-72 hours to yield results, leading to unnecessary antibiotic use in many cases. The study will involve collecting blood samples from children undergoing standard blood culture tests to evaluate the effectiveness of the molecular culture approach in identifying bacterial infections more rapidly. By comparing the results of molecular culture with conventional blood cultures, the study seeks to enhance diagnostic accuracy and reduce antibiotic overuse.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Undergoing collection of blood for a conventional blood culture as part of standard care OR
* Having undergone sepsis evaluation collection of blood for a conventional blood culture as part of standard care in the past 72 hours

Exclusion Criteria:

* Apart from an age criterion, there are no strict exclusion criteria. However, for the analysis of the secondary outcome (I.e. the testing of diagnostic accuracy of both MC as well as conventional culture for clinical sepsis), we plan to exclude all children who ultimately have a clear alternative cause for clinical illness that does not directly result from bacteraemia or bacterial sepsis. This will remain true in the case of conventional culture positivity, either when considered a contaminant as well as when considered a contributing factor in the presence of any of the causes of clinical illness mentioned below. A potential subject who meets any of the following criteria will be excluded from participation in this study These causes include, but are not limited to:
* In case of the potential inclusion of a neonate suspicious for EOS, confirmed congenital infection with TORCHES (toxoplasmosis, rubella, cytomegalovirus, syphilis and herpes) will lead to exclusion particularly for the neonatal population
* Auto inflammatory disease
* Hemophagocytic syndrome
* SIRS (Systemic Inflammatory Response Syndrome following a severe viral infection

Where it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting
• Spaarne Gasthuis
  Haarlem, Netherlands Recruiting

Study contacts

• Principal investigator: Tim de Meij, MD, PhD — Amsterdam UMC
• Study coordinator: Tim de Meij, MD, PhD
• Email: t.demeij@amsterdamumc.nl
• Phone: +3120 566 9111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Identifying biomarkers for diagnosing sepsis in the emergency room

  This study is trying to find out if certain immune responses can help doctors spot sepsis in patients with infections when they arrive at the emergency room.

  Recruiting at 2 sites Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Almere Stad, Flevoland and 2 other locations · NCT06178822

• Rapid identification of microbial species and antibiotic resistance in emergency department patients with infections

  This study is testing new ways to quickly identify germs and their resistance to antibiotics in patients with infections in the emergency department to help doctors treat them better and faster.

  Recruiting at 2 sites Michigan State University · Lansing, Michigan and 1 other locations · NCT01904188

• Ruta C and Vitamin C in Sepsis: Adding antioxidants to standard care

  This trial tests whether adding Ruta C (rutin plus vitamin C) or vitamin C alone to standard sepsis treatment helps adults in the ICU stay shorter and recover better.

  Recruiting Ain Shams University · Cairo, Cairo Governorate · NCT07922213

• Early detection of sepsis-related blood clotting problems in severe burn patients

  This study tests how well the JAAM-2 score can detect sepsis-induced coagulopathy early in adults with severe burns who develop sepsis in the ICU.

  Recruiting Center for Traumatology and Major Burns, Ben Arous · Tunis · NCT07914205

• Neutrophil EMR3 as a biomarker for sepsis in ICU patients

  Researchers will test whether measuring EMR3 on neutrophils helps diagnose sepsis, monitor progression, and predict outcomes in adults in Chinese ICUs.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang · NCT07896018

• Thymalfasin added to standard care for adults with sepsis and immune dysfunction

  This study tests whether thymosin alpha-1 helps restore immune function in adults with sepsis who have weakened immunity.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07866118

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.