Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05681442 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis

Study acronym: BICCS
StatusActive, Not Recruiting
PhasePhase 4
Started2023-11-13
View on ClinicalTrials.gov ↗

Amendment history

2026-09-08
Study Status, Contacts/Locations v23
Enrollment closed, study ongoing
Study sites28→26
2026-02-24
Study Status v22
Primary completion date2025-12-01→2027-01-04
Completion date2025-12-01→2027-06-04
2025-11-19
Study Status, Oversight, Contacts/Locations v21
Study sitesdetails revised at 3 of 28 sites
2025-07-30
Study Status, Contacts/Locations v20
Study sites27→28
2025-06-11
Study Status, Eligibility v19
Eligibility criteria+90 characters
Inclusion Criteria: Adults (≥ 18 years) Hospital-acquired sepsis or septic shock diagnosed in the past 24 hours (according to sepsis 3.0 definitions) : Patient hospitalized for more than 48 hours OR Patient discharged less than 48 hours ago AND sepsis diagnosed within the last 24 hours One of the following risk factors for gram negative multidru [...] olonged hospital stay (≥ 15 days of hospitalization) within 903 daysmonths prior to thesepsis occurrenceonset of sepsis Prolonged mechanical ventilation (≥ 5 days on mechanical ventilation) within 903 daysmonths prior to sepsis onset Patients with indwe [...] [...]
Show 18 earlier versions
2024-12-13
Study Status, Oversight, Contacts/Locations v18
Primary completion date2024-09-01→2025-12-01
Completion date2025-01-01→2025-12-01
Study sites24→27
2024-07-10
Study Status, Contacts/Locations v17
Study sitesdetails revised at 1 of 24 sites
2024-06-28
Study Status, Contacts/Locations v16
Study sitesdetails revised at 10 of 24 sites
2024-04-10
Study Status, Contacts/Locations v15
Study sitesdetails revised at 2 of 24 sites
2024-03-20
Study Status, Contacts/Locations v14
Study sitesdetails revised at 3 of 24 sites
2024-03-08
Study Status, Contacts/Locations v13
Study sitesdetails revised at 1 of 24 sites
2024-02-29
Study Status, Contacts/Locations v12
Study sitesdetails revised at 4 of 24 sites
2024-02-13
Study Status, Contacts/Locations v11
Study sitesdetails revised at 3 of 24 sites
2024-02-12
Study Status, Contacts/Locations v10
Study sitesdetails revised at 2 of 24 sites
2024-02-06
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 24 sites
2024-02-05
Study Status, Contacts/Locations v8
Study sitesdetails revised at 2 of 24 sites
2024-01-24
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 24 sites
2024-01-08
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 24 sites
2023-12-05
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 24 of 24 sites
2023-11-14
Not Yet Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Active, Not Recruiting
Primary completion date2024-08-01→2024-09-01
Completion date2024-12-01→2025-01-01
Start dateestimated 2023-08-01→confirmed 2023-11-13
Study sitescontacts updated at 23 of 24 sites
2023-08-04
Study Status, Study Description, Eligibility v3
Primary completion date2024-04-01→2024-08-01
Completion date2024-09-01→2024-12-01
Start date2023-05-01→2023-08-01
Eligibility criteria+2,066 characters
Inclusion Criteria: Adults (≥ 18 years) Hospital-acquired sepsis or septic shock diagnosed in the past 24 hours (according to sepsis 3.0 definitions) One of the following risk factors for gram negative multidrug resistant pathogens: Prior intravenous antibiotic [...] carriers of MDR gram negative bacteria in the past 3 months Exposure to an antibiotic (amoxicillin-clavulanic acid, C2G, C3G, fluoroquinolones) in the previous 3 months A trip abroad within 3 months to known geographical areas at risk (in particular the Indian subcontinent, South-East Asia, the Middle East and North Africa, the Mediterr [...] [...]
2023-04-05
Study Status v2
Start date2023-03-01→2023-05-01
2023-02-01
Study Status v1
Re-verified, no change to tracked fields
2022-12-26
Original filing
Patients hospitalized in ICU with sepsis (infection with life-threatening organ dysfunction according to sepsis 3.0 definitions) or septic shock presumably due to MDR-GNB (multidrug resistant Gram-negative bacteria). The study will be a prospective multicentre, randomized, open-label comparative continuous vs. intermittent pivotal βL (Beta Lactamine) antibiotic infusion strategies and combination vs. monotherapy trial conducted with a 2X2 factorial design.
Trial Details
NCT Number NCT05681442
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Sepsis
Enrollment 600 participants
Start Date 2023-11-13
Primary Completion 2027-01-04 (estimated)
Study Completion 2027-06-04 (estimated)
Updated on ClinicalTrials.gov 2026-09-11