Continuous vs. intermittent beta-lactam dosing in critically ill patients with sepsis: A randomized controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202009811610400

Enrollment

408

Registered

2020-09-16

Start date

2020-09-21

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Interventions

Continuous infusion of beta lactam antibiotic

Intermittent bolus of beta lactam antibiotic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients, adult and paediatric, admitted to the intensive care unit with sepsis Prescription of one of four beta lactam antibiotics by treating doctor: 1. Amoxicillin- clavulanate 2. Piperacillin-tazobactam 3. Meropenem 4. Imipenem Anticipated ICU at least 48 hours.

Exclusion criteria

Exclusion criteria: Pregnancy Less than 1 month old Chronic renal failure (eGFR 14 days (eg: infective endocarditis, osteomyelitis) Patients receiving palliative care at study assessment Patient previously enrolled on this study Declined consent

Design outcomes

Primary

Measure	Time frame
Adults - To compare the clinical cure rates at day 14 (D14) post randomization to the antibiotic strategy;Paediatrics - To determine the proportion of patients in the IB group with an expected time above minimum inhibitory concentration (MIC) of less than 100%	—

Secondary

Measure	Time frame
To compare the 2 groups with respect to the following in both adult and paediatric groups 1. The time above minimum inhibitory concentration in the 2 groups on day 3 2. Duration of antibiotics between the 2 groups 3. Normalization of an abnormal white cell count 4. Colonization or infection with new organisms 5. Duration of ventilation 6. Duration of vasopressor support 7. Duration of (RRT) renal replacement 8. ICU length of stay (LOS) 9. ICU mortality 10. Day 28/hospital discharge mortality 11. Day 90 mortality 12. Paediatrics clinical cure rates at day 14 (D14) post randomization to the antibiotic strategy.	—

Measure

Time frame

To compare the 2 groups with respect to the following in both adult and paediatric groups 1. The time above minimum inhibitory concentration in the 2 groups on day 3 2. Duration of antibiotics between the 2 groups 3. Normalization of an abnormal white cell count 4. Colonization or infection with new organisms 5. Duration of ventilation 6. Duration of vasopressor support 7. Duration of (RRT) renal replacement 8. ICU length of stay (LOS) 9. ICU mortality 10. Day 28/hospital discharge mortality 11. Day 90 mortality 12. Paediatrics clinical cure rates at day 14 (D14) post randomization to the antibiotic strategy.

—

Countries

South Africa

Contacts

Public ContactShahed Omar

Head of Research

shahedicu@gmail.com+27835695363

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026