Evaluating the influence of abnormalities in immunity due to an extreme reaction to an infection (sepsis) on antibiotic use in critically ill patients

Not Applicable

• Conditions: Hospitalised adults who have been commenced on intravenous antibiotics for sepsis; Infections and Infestations; Sepsis

• Registration Number: ISRCTN86837685
• Lead Sponsor: niversity of Manchester

Brief Summary

2022 Protocol article in http://dx.doi.org/10.1136/bmjopen-2022-068321 (added 16/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-05
• Last Update Posted: 8 May 2023
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

Patients enrolled in the ADAPT-sepsis trial. Patients are eligible if:
1. Hospitalised adult patients at least 18 years of age
2. Up to 24 hours of initiation of empiric intravenous antibiotic treatments for suspicion of sepsis
3. Likely to remain hospitalised and receiving intravenous antibiotic treatment for at least the next 72 hours
4. Requirement for critical care

Exclusion Criteria

1. More than 24 hours since receiving first empiric intravenous antibiotic treatments for a suspicion of sepsis
2. Prolonged (greater than 21 days) antimicrobial therapy mandated (e.g. for endocarditis, cerebral/hepatic abscess, tuberculosis, osteomyelitis)
3. Severely immunocompromised (e.g. neutropenia, less than 500 neutrophils/microlitre)
4. All treatment for suspected sepsis likely to be stopped within 24 hours of its initiation because of futility
5. Consent declined
6. Previously enrolled in ADAPT-sepsis

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune phenotype measured using fluorescence-based flow cytometry of blood samples taken at ...<br>1. Monocyte HLA-DR<br>2. Neutrophil CD88<br>3. T cell, monocyte and neutrophil CD279<br>4. Percentage of regulatory T cells

Secondary Outcome Measures

Name	Time	Method
Measured using patient records:<br>1. Total duration of antibiotic treatment to 28 days following randomisation (superiority) measured in days (24-hour time periods)<br>2. Antibiotic dose, measured as Defined Daily Dose to 28 days<br>3. Unscheduled care escalation/re-admission<br>4. Infection relapse/recurrence requiring further antibiotic treatment<br>5. Super-infection, defined as new infection at a different anatomical site<br>6. Suspected antibiotic adverse reactions<br>7. Time to ‘fit’ for hospital discharge