DrugEvidence

Diseases / Sepsis

Sepsis

Disease

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Without early recognition and treatment, it can progress to septic shock, multi-organ failure, and death.

Trials
2265
Recruiting
232
Completed
1150
With results
145

Last revised

Pipeline

Phase by status

PhaseRecruitingNot yetBy invitationActiveCompletedTerminatedWithdrawnSuspendedUnknownApproved for marketingNo longer availableTotal
Early Phase 1 22 4
Phase 1 3246721 61
Phase 1/2 231119325 36
Phase 2 1352761111124 143
Phase 2/3 212171113 46
Phase 3 127190176225 160
Phase 4 1811146912423 142
Not applicable 5642282933021197 550
Unknown 1247815275342825328612 1123

Trials started per year

2021
35
2022
131
2023
136
2024
146
2025
120
2026
165
2027
8

Conditions studied, by phase

ConditionEarly Phase 1Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Not applicableUnknownTotal
Sepsis 46136143461601425501123 2265
Shock, Septic 1141352164940128225 538
Critical Illness 5473764585 162
Infections 1111213112991 159
Acute Kidney Injury 461582352 99
Systemic Inflammatory Response Syndrome 1262541551 86
Bacteremia 14881741 79
Shock 2172741837 78
Pneumonia 1121101545 75
Respiratory Distress Syndrome 321051528 63

Most active sponsors

#SponsorTrialsPhase 3
1Assistance Publique - Hôpitaux de Paris315
2Ain Shams University273
3Assiut University231
4National Taiwan University Hospital211
5Chinese PLA General Hospital200
6Southeast University, China202
7Tanta University191
8Radboud University Medical Center165
9Mayo Clinic150
10University of Florida150

Most studied interventions

#InterventionTrials
1Blood Specimen Collection51
2Saline Solution43
3Sodium Chloride34
4Ascorbic Acid33
5Hydrocortisone26
6Standard of Care26
7Meropenem24
8Thiamine19
9Norepinephrine18
10Dexmedetomidine14

Evidence

Results reported
12.6%145 of 1150 completed
Published
17.3%199 of 1150 completed
Primary endpoint met
25%17 of 68 analyses
Median months to report
14

Documents disclosed

Protocol available
116
Statistical analysis plan
110
PubMed citations
869

Trial profile

Median enrollment
116
Median duration
24months
Countries
114
Study sites
6990

Who is enrolled

Adults
2095
Children
439
Older adults
1957
Healthy volunteers
290

Median enrollment by phase

Early Phase 1
110
Phase 1
30
Phase 1/2
40
Phase 2
69
Phase 2/3
108
Phase 3
238
Phase 4
100
Not applicable
100
Unknown
150

Where trials run

United States
489
China
261
France
197
Germany
138
Egypt
95
United Kingdom
93
Italy
90
Canada
81
Netherlands
74
Spain
71

Busiest cities

#CityCountryTrials
1ParisFrance69
2BostonUnited States65
3BeijingChina53
4HoustonUnited States50
5LondonUnited Kingdom49
6ShanghaiChina48
7BrusselsBelgium46
8BarcelonaSpain43
9DetroitUnited States43
10NanjingChina42

Terminations

Terminated
115
Withdrawn
72
Suspended
8
Stopped for recruitment
2.1%48 of 2265 trials

Stated reasons

Other / unclear
95
Recruitment
48
Funding
20
Regulatory
13
Lack of efficacy
9
COVID-19
8
Business decision
1
Safety
1

Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.

Recently stopped

TrialStatusStated reasonStopped
NCT04110912 Withdrawn Withdrawn No longer proceeding with application 2040-12-31
NCT07492875 Withdrawn Withdrawn New protocol developed 2029-12-31
NCT04742764 Suspended Suspended The human resources required to start enrollment were not available anymore. 2027-10-31
NCT03278730 Suspended Suspended Lack of resources to start 2027-02-28
NCT07492888 Withdrawn Withdrawn New protocol developed 2027-01-15
NCT06668870 Withdrawn Withdrawn protocol changes were made and study no longer a clinical trial 2026-10-31
NCT06627842 Suspended Suspended Temporary suspended. Wait for IRB approval (inclusion duration modified) 2026-10-01
NCT06885528 Terminated Terminated The study was discontinued due to a change in the company's strategic priorities for its hematology platform and was not related to concerns regarding the clinical performance, validity, or safety of MDW. 2026-07-08
NCT06217939 Terminated Terminated The study was terminated early on December 25, 2025, following the Data and Safety Monitoring Board (DSMB) recommendation due to preliminary evidence of futility. 2026-04-25
NCT05148117 Withdrawn Withdrawn Could not get through IRB submission and co-investigators with needed skillsets for study departed organization 2026-01-14

Trial records

Individual study records live on ClinicalTrials.gov. A sample of the trials counted above:

Search all Sepsis trials on ClinicalTrials.gov →