Pneumonia Clinical Trial
Official title:
Changes in the Oropharyngeal Flora in Hospitalised Patients
NCT number | NCT02303301 |
Other study ID # | ProOro |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | July 2020 |
Verified date | October 2020 |
Source | Region Skane |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hospitalised patients have in contrast to healthy people enteric pathogenic bacteria in their oropharynx Increased risk of pneumonia due to the pathogens in the oropharynx Probiotics can reduce such bacteria in intubated critically ill patients This study will use two strain of probiotic bacteria for half of the patients and a placebo for the rest Active arm gurgles with a suspension twice a day Cultures at inclusion and at set time intervals The results of cultures from the two groups will be compared as will the use of antibiotics
Status | Completed |
Enrollment | 145 |
Est. completion date | July 2020 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Admitted to hospital - Anticipated length of hospital stay 3 days or more Exclusion Criteria: - Immune insufficiency - Prior participation in the study - Not being able to understand study information |
Country | Name | City | State |
---|---|---|---|
Sweden | Lund University Hospital | Lund |
Lead Sponsor | Collaborator |
---|---|
Region Skane | Probi AB |
Sweden,
Johanson WG, Pierce AK, Sanford JP. Changing pharyngeal bacterial flora of hospitalized patients. Emergence of gram-negative bacilli. N Engl J Med. 1969 Nov 20;281(21):1137-40. — View Citation
Klarin B, Molin G, Jeppsson B, Larsson A. Use of the probiotic Lactobacillus plantarum 299 to reduce pathogenic bacteria in the oropharynx of intubated patients: a randomised controlled open pilot study. Crit Care. 2008;12(6):R136. doi: 10.1186/cc7109. Ep — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | New appearing pathogenic bacteria in the oropharynx | Oropharyngeal cultures taken at admission and at specified days thereafter in all patients Results from Clin Microbiology assessed and all relevant findings will be treated according to patterns of antibiotic resistance | During hospital stay, Average 7 days | |
Secondary | Pneumonia | Appearing health care related pneumonia. Treating physicians at the wards follow the patients condition and progress. Ward physicians prescribes antibiotics and chest x-rays on clinical grounds | During hospital stay, Average 7 days | |
Secondary | Length of hospital stay | Hospital stay , Days | During hospital stay, Average 7 days |
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