A study to determine whether continuous infusion of beta-lactam antibiotics compared with intermittent infusion of beta-lactam antibiotics decreases mortality in critically ill patients

Phase 1

• Conditions: Sepsis; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; MedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2017-004637-85-BE
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-26
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 7600

Inclusion Criteria

1. Patient has a documented site of infection or strong suspicion of infection
2. Patient is expected to be in the ICU the day after tomorrow
3. Patient has been commenced on piperacillin-tazobactam or meropenem to treat the episode of infection
4. Giving piperacillin-tazobactam or meropenem by intermittent infusion or continuous infusion is considered equally appropriate for the patient
5. One or more organ dysfunction criteria in the previous 24 hours
i. MAP < 60 mmHg for at least 1 hour
ii. Vasopressors required for > 4 hours
iii. Respiratory support using supplemental high flow nasal prongs, continuous positive airway pressure, bilevel positive airway pressure or invasive mechanical ventilation for at least 1 hour
iv. Serum creatinine concentration > 220 µmol/L or >2.49 mg/dL
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 192
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 288

Exclusion Criteria

1. Patient age is less than 18 years
2. Patient has received piperacillin-tazobactam or meropenem for more than 24 hours during current infectious episode
3. Patient is known or suspected to be pregnant
4. Patient has a known allergy to piperacillin-tazobactam, meropenem or penicillin
5. Patient is requiring renal replacement therapy at the time of randomisation, including renal replacement therapy for chronic renal failure
6. The attending physician or patient or surrogate legal decision maker is not committed to advanced life-support, including mechanical ventilation, dialysis and vasopressor administration, for at least the next 48 hours
7. Patient’s death is deemed imminent and inevitable
8. Patient has previously been enrolled in BLING III

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified