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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

No Placebo-Only Group

Pivotal 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
Difficult Weaning
Critical Illness
Bacterial Pneumonia

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hospital Mortality

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SDD intervention groupExperimental Treatment3 Interventions

The intervention will entail: 1. 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 2. 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 3. 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