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A pHase III cluster randomIsed controlled, cross-over, non-inferiority Trial of a short course, High dose AntimicRobials vs conventional dose and Duration in critically ill patients
EU CTIS ID: 2024-514730-21-00
What this study is testing
To determine the non-inferiority of a short course, high dose antimicrobial therapy in critically ill patients with pneumonia, intra-abdominal infection (IAI) or bloodstream infection (BSI) for all cause 90-day mortality. Our primary hypothesis is that a short course, high dose antimicrobial therapy results in similar outcomes compared to conventional duration and dose, while it results in a lower exposure to antimicrobials.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years.
- Patient with (suspicion of) community acquired pneumonia (CAP) or hospital acquired pneumonia (HAP) or ventilator acquired pneumonia (VAP) or intra- abdominal infection (IAI) or bloodstream infection (BSI) for which one of the following antimicrobials has been prescribed or has been commenced: ceftriaxone, cefotaxime, cefuroxime, piperacillin- tazobactam or meropenem. To note: The beta lactam antimicrobial is considered the pivotal antibiotic in a multidrug strategy: co-administration of other – non-study – antibiotics in standard dosage, e.g. to expand the spectrum of the empirical therapy (e.g. vancomycin, aminoglycosides), or because they are recommended in guidelines (e.g. macrolides) is allowed; these antimicrobials will be dosed as per local practice, and data will be collected.
- Treatment may be empirical or targeted (I.e. based on culture results)
- Patients must be admitted to the ICU and have to be expected to be hospitalized in the ICU until at least the day after tomorrow.
- Administering study related antimicrobials using either a short course, high dose treatment or conventional dose and duration treatment, are considered appropriate for the patient. To note: Patients with infections that require a (according to prevailing guidelines) higher than standard dose, or require a longer duration, e.g. endocarditis, Staphylococcus aureus bacteraemia or prosthetic joint infection, osteomyelitis... (non-limitative list) are therefore not to be included. Also patients in who(m) source control is evidently not achieved, cannot be included. Of course, some patients may be included but then need to ‘drop out’ because one of the above-mentioned diagnoses becomes apparent during the course of therapy e.g. S. aureus is cultured from blood in a patient with CAP. This will lead to secondary exclusion of the patient (“drop out”).
- One or more organ dysfunction criteria in the previous 24 hours and ongoing: - MAP < 60mmHg for at least 1 hours. - Vasopressor required for > 4 hours. - Respiratory support using supplemental high flow nasal oxygen, continuous positive airway pressure, bilevel positive airway pressure or invasive mechanical ventilation for at least 1 hour. - Serum creatinine concentration > 220µmol/L or >2.49 mg/dL.
You likely can't join if
- Patient is known or suspected to be pregnant.
- Patient has received the study related antimicrobial for more than 12 hours prior to inclusion in the study.
- Patient has a proven severe allergy for one of the study antibiotics. To note:In case of a documented non-severe (suspected) allergy for one of the study antibiotics: choice of antibiotic according to local protocol, on discretion of the treating physician.
- The attending physician or patient or legal representative is not committed to full active treatment. To note: Limitation of cardiopulmonary resuscitation (CPR) only is not an exclusion criterium.
- The patient is treated for an infection that requires a higher than standard dose or longer than the CONTROL strategy. To note: Patients with infections that require a (according to prevailing guidelines) higher than standard dose, or require a longer duration, e.g. endocarditis, Staphylococcus aureus bacteraemia or prosthetic joint infection, osteomyelitis... (non-limitative list) are therefore not to be included. Also patients in who(m) source control is evidently not achieved, cannot be included. Of course, some patients may be included but then need to ‘drop out’ because one of the above-mentioned diagnoses becomes apparent during the course of therapy e.g. S. aureus is cultured from blood in a patient with CAP. This will lead to secondary exclusion of the patient (“drop out”).
- The patient has previously been enrolled in the HIT-HARD study.
See the full eligibility criteria
Who can join
- Age ≥18 years.
- Patient with (suspicion of) community acquired pneumonia (CAP) or hospital acquired pneumonia (HAP) or ventilator acquired pneumonia (VAP) or intra- abdominal infection (IAI) or bloodstream infection (BSI) for which one of the following antimicrobials has been prescribed or has been commenced: ceftriaxone, cefotaxime, cefuroxime, piperacillin- tazobactam or meropenem. To note: The beta lactam antimicrobial is considered the pivotal antibiotic in a multidrug strategy: co-administration of other – non-study – antibiotics in standard dosage, e.g. to expand the spectrum of the empirical therapy (e.g. vancomycin, aminoglycosides), or because they are recommended in guidelines (e.g. macrolides) is allowed; these antimicrobials will be dosed as per local practice, and data will be collected.
- Treatment may be empirical or targeted (I.e. based on culture results)
- Patients must be admitted to the ICU and have to be expected to be hospitalized in the ICU until at least the day after tomorrow.
- Administering study related antimicrobials using either a short course, high dose treatment or conventional dose and duration treatment, are considered appropriate for the patient. To note: Patients with infections that require a (according to prevailing guidelines) higher than standard dose, or require a longer duration, e.g. endocarditis, Staphylococcus aureus bacteraemia or prosthetic joint infection, osteomyelitis... (non-limitative list) are therefore not to be included. Also patients in who(m) source control is evidently not achieved, cannot be included. Of course, some patients may be included but then need to ‘drop out’ because one of the above-mentioned diagnoses becomes apparent during the course of therapy e.g. S. aureus is cultured from blood in a patient with CAP. This will lead to secondary exclusion of the patient (“drop out”).
- One or more organ dysfunction criteria in the previous 24 hours and ongoing: - MAP < 60mmHg for at least 1 hours. - Vasopressor required for > 4 hours. - Respiratory support using supplemental high flow nasal oxygen, continuous positive airway pressure, bilevel positive airway pressure or invasive mechanical ventilation for at least 1 hour. - Serum creatinine concentration > 220µmol/L or >2.49 mg/dL.
What rules you out
- Patient is known or suspected to be pregnant.
- Patient has received the study related antimicrobial for more than 12 hours prior to inclusion in the study.
- Patient has a proven severe allergy for one of the study antibiotics. To note:In case of a documented non-severe (suspected) allergy for one of the study antibiotics: choice of antibiotic according to local protocol, on discretion of the treating physician.
- The attending physician or patient or legal representative is not committed to full active treatment. To note: Limitation of cardiopulmonary resuscitation (CPR) only is not an exclusion criterium.
- The patient is treated for an infection that requires a higher than standard dose or longer than the CONTROL strategy. To note: Patients with infections that require a (according to prevailing guidelines) higher than standard dose, or require a longer duration, e.g. endocarditis, Staphylococcus aureus bacteraemia or prosthetic joint infection, osteomyelitis... (non-limitative list) are therefore not to be included. Also patients in who(m) source control is evidently not achieved, cannot be included. Of course, some patients may be included but then need to ‘drop out’ because one of the above-mentioned diagnoses becomes apparent during the course of therapy e.g. S. aureus is cultured from blood in a patient with CAP. This will lead to secondary exclusion of the patient (“drop out”).
- The patient has previously been enrolled in the HIT-HARD study.
- Use of the study related antimicrobial as prophylactic therapy administered as the IV component of SDD strategy, without proven infection. Oral / enteral components of SDD may be used in patients included in the HITHARD study, as long as the pivotal study antibiotic is administered because of an infection as per the inclusion criteria.
- Patient is requiring renal replacement therapy at the time of randomisation, including renal replacement therapy for chronic kidney disease.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.