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Antibiotic

SDD Gastric Suspension for Sepsis (SuDDICU Trial)

Phase 3

Waitlist Available

Research Sponsored by The George Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through out all study periods

Awards & highlights

SuDDICU Trial Summary

This trial will help to determine if SDD is an effective intervention for critically ill patients and if it is cost effective.

Eligible Conditions

Sepsis
Critical Illness
Septic Shock
Bacterial Pneumonia

SuDDICU Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hospital discharge [up to day 90 after randomization]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hospital discharge [up to day 90 after randomization]

This trial's timeline: 3 weeks for screening, Varies for treatment, and hospital discharge [up to day 90 after randomization] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hospital Mortality

Secondary outcome measures

Changes in antibiotic resistance rates between study epochs (pre-trial, interperiod gap and post-trial) within groups

Duration of mechanical ventilation

Hospital length of stay

+6 more

SuDDICU Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SDD intervention groupExperimental Treatment3 Interventions

The intervention will entail: A six-hourly topical application of 0.5g paste, containing colistin 10mg, tobramycin 10mg and nystatin 125,000 IU, to the buccal mucosa and oropharynx A six-hourly administration of 10 mL of a suspension containing 100 mg colistin, 80 mg tobramycin and 2 x 10^6 IU nystatin, to the gastrointestinal tract via a gastric/post-pyloric tube A four-day course of an IV antibiotic. Patients not already receiving a therapeutic antibiotic will be prescribed cefotaxime 1g six-hourly or ceftriaxone 1g daily, with dose adjusted as appropriate for organ dysfunction. Ciprofloxacin (400mg 12-hourly) may be used as an alternative if there is a contraindication to cephalosporins (e.g. allergy). Patients already receiving an alternative IV antibiotic to treat infection will not receive this additional IV antibiotic, but will continue the prescribed antibiotic for the usual duration of therapy.

Group II: Control group- standard careActive Control1 Intervention

Standard care- In Australia there are no national guidelines so local policy is determined by each ICU. We are recommending (but not mandating) that control and SDD group management be in line with these national guidelines. We will recommend control and SDD group management is in line with current national standards of practice that may or may not include a VAP bundle. We will monitor record data regarding the nature and delivery of the control and SDD group co-interventions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SDD Oral Paste

2017

Completed Phase 3

~20010

SDD Gastric Suspension

2017

Completed Phase 3

~20010

Intravenous Antibiotic

2017

Completed Phase 3

~20010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The George InstituteLead Sponsor

76 Previous Clinical Trials

245,746 Total Patients Enrolled

1 Trials studying Sepsis

7,203 Patients Enrolled for Sepsis

Imperial College LondonOTHER

990 Previous Clinical Trials

14,885,369 Total Patients Enrolled

7 Trials studying Sepsis

4,443 Patients Enrolled for Sepsis

Sunnybrook Health Sciences CentreOTHER

656 Previous Clinical Trials

1,530,612 Total Patients Enrolled

4 Trials studying Sepsis

4,212 Patients Enrolled for Sepsis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what sort of infections is Intravenous Antibiotic most effective?

"Intravenous Antibiotic can be used to eliminate bacteria causing ear infections, urinary tract infections, and other ailments."

Answered by AI

How many human participants are included in this experiment?

"Yes, as of right now this clinical study is actively recruiting patients. It was first posted on May 1st, 2017 and the most recent update occurred on April 11th, 2022. The trial is only enrolling at a single location but are looking for 15000 individuals to participate."

Answered by AI

Could you please remind me of what other intravenous antibiotic clinical trials have been completed?

"There are currently 58 active clinical trials investigating the efficacy of Intravenous Antibiotics. Of these, 15 have reached Phase 3. Although several research centres for this topic are located in Durham, North carolina, there are 515 locations running studies on Intravenous Antibiotics globally."

Answered by AI

Are there any risks associated with Intravenous Antibiotic use?

"There is some evidence from earlier trials to support the efficacy of Intravenous Antibiotics, and multiple rounds of testing have shown that it is safe. Therefore, we give it a score of 3."

Answered by AI

Recent research and studies

Critical CareJournal

Clinical Stakeholders’ Opinions on the Use of Selective Decontamination of the Digestive Tract in Critically Ill Patients in Intensive Care Units: An International Delphi Study

Cuthbertson, Brian H, Marion K Campbell, Graeme MacLennan, Eilidh M Duncan, Andrea P Marshall, Elisabeth C Wells, Maria E Prior, et al.. 2013. “Clinical Stakeholders’ Opinions on the Use of Selective Decontamination of the Digestive Tract in Critically Ill Patients in Intensive Care Units: An International Delphi Study”. Critical Care. Springer Science and Business Media LLC. doi:10.1186/cc13096.

The Lancet Infectious DiseasesJournal

Effect of Selective Decontamination on Antimicrobial Resistance in Intensive Care Units: A Systematic Review and Meta-analysis

Daneman, Nick, Syed Sarwar, Robert A Fowler, and Brian H Cuthbertson. 2013. “Effect of Selective Decontamination on Antimicrobial Resistance in Intensive Care Units: A Systematic Review and Meta-analysis”. The Lancet Infectious Diseases. Elsevier BV. doi:10.1016/s1473-3099(12)70322-5.

TrialsJournal

A Study of the Perceived Risks, Benefits and Barriers to the Use of SDD in Adult Critical Care Units (the Suddicu Study)

Cuthbertson, BH, the SuDDICU study groups, J Francis, MK Campbell, L MacIntyre, I Seppelt, and J Grimshaw. 2010. “A Study of the Perceived Risks, Benefits and Barriers to the Use of SDD in Adult Critical Care Units (the Suddicu Study)”. Trials. Springer Science and Business Media LLC. doi:10.1186/1745-6215-11-117.

clinicaltrials.govStudy