Selective Digestive Decontamination (SDD) - Selective Orophayngeal Decontamination (SOD) trial
| ISRCTN | ISRCTN35176830 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35176830 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 30/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anne Marie G A de Smet
Scientific
Scientific
University Medical Center Utrecht, AZU
PO Box 85500
Amsterdam
3508 GA
Netherlands
| Phone | +31 (0)30 2509111 |
|---|---|
| a.desmet@azu.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | SDD-SOD-trial |
| Study objectives | Can mortality in intensive care unit (ICU) patients be reduced by using SDD or SOD as infection prevention measure, without increasing the development of antibiotic resistance? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Infection in ICU patients |
| Intervention | Selective Digestive Decontamination. Selective Oropharyngeal Decontamination. |
| Intervention type | Other |
| Primary outcome measure | 1. Hospital mortality 2. ICU-mortality |
| Secondary outcome measures | 1. Prevalence of antibiotic resistance 2. Duration of mechanical ventilation, 3. Duration of ICU-stay, 4. Incidence of hospital infections, 5. Antibiotic use, 6. Health care costs. |
| Overall study start date | 01/05/2004 |
| Completion date | 24/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target number of participants | 3,450 |
| Key inclusion criteria | All patients admitted to the ICU with an expected stay> 72 hours in ICU or with an expected duration of mechanical ventilation > 48 hours |
| Key exclusion criteria | 1. Known allergy to study-medication in patient-history 2. Pregnancy |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 24/07/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht, AZU
Amsterdam
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
University Medical Centre Utrecht (Netherlands)
University/education
University/education
PO Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Other
Dutch SDD Trialists Group (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2009 | Yes | No | |
| Results article | survery results | 01/01/2010 | Yes | No | |
| Results article | 11 results | 01/05/2011 | Yes | No |
