InfectionPhase 2NCT02899143
Short-course Antimicrobial Therapy in Sepsis
A Phase 2 study testing Antibiotic in people with Infection and Sepsis, run by Ospedale Santa Maria delle Croci at 4 sites in Italy.
Trial summary
The purpose of this study is to compare the effect of a short course antimicrobial therapy (5-days) versus a 10-days therapy on sepsis-related organ dysfunction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection, Sepsis, Severe Sepsis
- What is being tested?
- Antibiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 4 sitesItaly
- Study dates
- Sep 2016to Oct 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who received antibiotics for presumed infection
Who cannot join
- Prolonged therapy (eg, endocarditis)
- Severe immunosuppression
- Severe infections (due to viruses, parasites, or Mycobacterium tuberculosis)
- Patients previously infected or colonized with multidrug resistant pathogens and moribund patients.
Trial locations and contacts
4 sites in 1 country.
Vincenzo De Santis contact
Italy4 sites, 4 recruiting
- Recruiting
Azienda Ospedaliera S.Croce e Carle - Ospedale S.Croce
Cuneo, 12100
Domenico Vitale, MD, dovitale@hotmail.com
- Recruiting
Ospedale Umberto I
Lugo, Ravenna
- Recruiting
ASST Fatebenefratelli Sacco
Milan, 20157
Alberto Corona, alberto.corona@asst-fbt-sacco.it
- Recruiting
Ospedale Santa Maria Delle Croci
Ravenna, 48121
Maurizio Fusari
About this study
Official title: Trial of Short-Course Antimicrobial Therapy for Sepsis in Intensive Care
The purpose of this study is to compare the effect of a short course antimicrobial therapy (5-days) versus a 10-days therapy on sepsis-related organ dysfunction.
- Conditions
- Infection, Sepsis, Severe Sepsis, Septic Shock
- Being tested
- Antibiotic
- Medical subject headings
- Infections, Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
Targeted antimicrobial therapy
| Study group | Role | What they receive |
|---|---|---|
| Group 5-days | Experimental | 5-days targeted antibiotic therapy Receives: Drug: Antibiotic |
| Group 10-days | Other | 10-days targeted antibiotic therapy Receives: Drug: Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
sepsis-related organ dysfunction
Score used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The Sequential Organ Failure Assessment (SOFA) score numerically quantifies the number and severity of failed organs. Higher values represent worse outcome. A score of 0 is given for normal function through to 4 for most abnormal. The systems studied are: respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal.
Measured: 14-days
Secondary outcomes (1)
Hospital mortality
In hospital mortality rate
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Santa Maria delle Croci
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo De Santis, Ospedale Santa Maria delle Croci
- Investigators
- Vincenzo De Santis, Principal investigator, Ospedale Santa Maria Delle Croci, Ravenna, AUSL Romagna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899143
- Sponsor's protocol ID
- 1599
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2016
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Short-Course Antimicrobial Therapy for Sepsis in Intensive Care
- ClinicalTrials.gov ID
- NCT02899143
- Acronym / sponsor ID
- 1599
- Conditions
- Infection, Sepsis, Severe Sepsis, Septic Shock
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Ospedale Santa Maria delle CrociUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effect of a short course antimicrobial therapy (5-days) versus a 10-days therapy on sepsis-related organ dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 5-days | Experimental | Drug: Antibiotic5-days targeted antibiotic therapy |
| Group 10-days | Other | Drug: Antibiotic10-days targeted antibiotic therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who received antibiotics for presumed infection
Key exclusion criteria (4 listed)
- Prolonged therapy (eg, endocarditis)
- Severe immunosuppression
- Severe infections (due to viruses, parasites, or Mycobacterium tuberculosis)
- Patients previously infected or colonized with multidrug resistant pathogens and moribund patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticTargeted antimicrobial therapy | Drug | Group 10-days, Group 5-days |
Primary outcome
sepsis-related organ dysfunction
Time frame: 14-days
Score used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The Sequential Organ Failure Assessment (SOFA) score numerically quantifies the number and severity of failed organs. Higher values represent worse outcome. A score of 0 is given for normal function through to 4 for most abnormal. The systems studied are: respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal.
1 secondary outcome
Hospital mortality
Time frame: 30-days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo De Santis contact
Vincenzo De Santis principal investigator
Ospedale Santa Maria Delle Croci, Ravenna, AUSL Romagna
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antibiotic in people with Infection and Sepsis, run by Ospedale Santa Maria delle Croci at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo De Santis (vincenzo.desantis@auslromagna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sepsis-related organ dysfunction (time frame: 14-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.