Using piperacillin-tazobactam and temocillin to treat severe infections in ICU patients
Piperacillin-tazobactam and Temocillin as Carbapenem-alternatives for the Treatment of Severe Infections Due to Extended-spectrum Beta-lactamase-Producing Gram-negative Enterobacteriaceae in the Intensive Care Unit
This study is testing if using piperacillin-tazobactam and temocillin can effectively treat severe infections in ICU patients instead of the usual carbapenem antibiotics.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT05565222 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of piperacillin-tazobactam and temocillin as alternatives to carbapenems for treating severe infections caused by extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae in intensive care unit (ICU) patients. The study aims to address the growing concern of antibiotic resistance associated with carbapenem use. Patients aged 18 and older who are hospitalized in the ICU with severe infections such as sepsis or septic shock will be enrolled. The trial will compare the outcomes of patients receiving these alternative antibiotics against those receiving meropenem.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are hospitalized in the ICU with severe infections due to ESBL-producing bacteria.
Not a fit: Patients with infections not caused by ESBL-producing Enterobacteriaceae or those who do not meet the criteria for severe infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for patients with severe infections while reducing the risk of developing antibiotic resistance.
How similar studies have performed: Previous studies have suggested that non-carbapenem antibiotics may be safe alternatives, but the effectiveness of this specific approach remains to be fully validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18-year-old * Hospitalized in the ICU * Severe infection, eg sepsis or septic shock (according to the Sepsis-3 definition) Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection, characterized by an increase of Sequential Organ Failure Assessment (SOFA) score of 2 points or more. This increase in 2 points will be calculated the day infection is diagnosed (day of positive culture serving as reference for the infection) as compared to the day before infection onset. Septic shock is defined as sepsis and persisting hypotension requiring vasopressors to maintain mean arterial pressure ≥65 mmHg and having a serum lactate level \>2 mmol/l despite adequate volume resuscitation. This criterion (sepsis or septic shock) has to be fulfilled within a time frame of +/- 24 hours from the day of infection diagnosis (i.e. the day of positive bacteriological sample). * Pathogen responsible for infection is an ESBL-producing Enterobacteriaceae susceptible to meropenem and either to piperacillin/tazobactam (minimum inhibitory concentration \<8 mg/L) or to temocillin (minimum inhibitory concentration ≤8 mg/L) * Signed Informed consent from patient/a legal representative/a family member/a close relative. According to the specifications of emergency inclusion, randomization without the close relative or surrogate consent could be performed if the patient is unable to give his/her consent and when the legal representative/family member or close relative are absent except patients included in another study for which emergency inclusion has already been used (see exclusion criteria n° 8). For these patients, emergency inclusion cannot be used). Close relative/surrogate/family consent will be asked as soon as possible. The patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow * Affiliation to social security (AME excluded) Exclusion Criteria: * Pregnancy or breastfeeding * Known allergy to beta-lactam * Patient with severe neutropenia, as defined by absolute neutrophil count \<0.5x109/L * Infection requiring prolonged antimicrobial treatment (endocarditis; mediastinitis; osteomyelitis/septic arthritis; undrainable/undrained abscess; unremovable/unremoved prosthetic-associated infection) * Moribund, defined by a SAPS II score at inclusion \>75 * Decision of withholding/withdrawing care * Patient with concomitant infection requiring antibiotics with activity against Gram-negative bacilli, including patient with polymicrobial infection with pathogen resistant to study drugs * Participation in another interventional study evaluating drugs or being in the exclusion period at the end of a previous study evaluating drugs . * Hypersensitivity to any components of the formulations
Where this trial is running
Paris and 1 other locations
- LUYT Charles -Edouard — Paris, France (Recruiting)
- MAYAUX Julien — Paris, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.