The HIT-HARD Study
Welcome to the website of the HIT-HARD study.
This study investigates whether a shorter, higher-dose course of antibiotics in critically ill patients in the intensive care (ICU) is as effective as the current standard treatments. Together, we aim for a future with more appropriate antibiotic use and better care.
About the study
A large clinical trial designed to evaluate whether a short, high-dose antibiotic course is as effective as a standard-duration, normal-dose treatment in critically ill patients.
14
participating centers
Fourteen hospitals in Belgium and the Netherlands are taking part in this study.
The study started on July 1st, 2025!
Who can participate?
The HIT-HARD study investigates antibiotic treatment strategies in adult ICU patients with severe infections such as pneumonia, intra-abdominal infection, or bloodstream infection.
Participants receive one of five commonly used antibiotics and show signs of organ dysfunction.
They must be eligible for both a short, high-dose treatment and a conventional course, according to the treating physician’s assessment, and are expected to remain in the ICU for at least two days.
How does the study work?
The HIT-HARD study examines whether a shorter, high-dose antibiotic course is as safe and effective as standard treatment in ICU patients with severe infections.
In 14 hospitals (7 in Belgium, 7 in the Netherlands), a total of 1,282 patients will be enrolled over a 30-month period.
Each center will switch treatment strategy after 15 months.
Data will be collected from the medical record, a blood sample, and follow-up (by phone) on days 28 and 90.
Informed consent must be obtained as soon as possible after treatment initiation.
General information
Read more about what the study entails.
General information can be found in the Study Protocol. The general information, purpose, background, and procedure of the study are included here.
All documents are available in the ‘Study protocol and downloads‘ section.
Only patients who meet the ‘inclusion and exclusion criteria’ and are treated in one of the ‘participating centers’ can take part.
The ICU physician determines whether a patient can be enrolled.
Patients cannot sign up themselves but can provide consent after registration by their physician.
Since this is a cohort study, no new hospitals can join at this stage.
Information for healthcare professionals
- Inclusion criteria and selection process
All information can always be requested from or consulted with the hospital’s study team. In addition, you can also consult all necessary information in the documents below.
- Study protocol & downloads
Study protocol
Informed consent – BE (NL)
Informed consent – BE (FR)
Informed consent – BE (ENG)
Informed consent – NL
- Co-enrolment list
Participating centers
Fourteen hospitals are taking part in this study: seven in Belgium and seven in the Netherlands.
Because we are comparing two different antibiotic strategies, not all hospitals start with the same approach.
Hospitals are randomly assigned to one of two starting strategies.
Half begin with the standard antibiotic strategy, while the other half start with the new approach (higher dose, shorter duration).
After 15 months, the hospitals switch strategies.
This way, both strategies are implemented in each hospital, allowing for a fair and rigorous comparison of the results.
“With the HIT-HARD study, we are asking a simple but important question:
Can we treat infections in critically ill patients more effectively using higher doses over a shorter period?”
Jan De Waele, Nynke Jager en Jeroen Schouten
Primary investigators
Daisy Vermeiren (PM), Lieke Roest (PM/PhD) en Matteo Demaria (PhD)
Project managers (PM)/ PhD students
Contact information
Please consult the “Key Trial Contacts” section of the study protocol (see ‘Studyprotocol & downloads‘)
For practical questions, contact:
- Daisy Vermeiren hithard@uzgent.be
For content-related questions, contact:
- Lieke Roest hithard.apo@radboudumc.nl
Lead institution
UZ Gent – Intensive Care Unit
Corneel Heymanslaan 10, 9000 Ghent, Belgium
Coordinating center (NL)
Radboudumc – Department of Pharmacy, Pharmacology and Toxicology
Geert Grooteplein Zuid 10, 6525 GA Nijmegen, The Netherlands
Funding
This study is funded under the BeNeFIT 3 programme, a collaboration between KCE and ZonMW.
Participating centers
Here you can find the full list of participating hospitals and the principal investigator for each center.
Belgium
UZ Gent
ZNA Cadix Antwerpen
AZ Delta Roeselare
AZ Sint-Lucas Gent
HUB Hôpital Erasme
Clinique Saint-Pierre
CHU Liège
The Netherlands
Radboudumc
CWZ Nijmegen
Rijnstate Arnhem
UMCG
ZGT Almelo
Franciscus
Gelre ziekenhuizen