Trial Outcomes & Findings for Clinical Characteristics and Microbiology of Healthcare Associated Pneumonia (NCT NCT01966796)

NCT ID: NCT01966796

Last Updated: 2020-09-09

Results Overview

sputum culture and sterile specimen such as blood or pleural effusion culture for healthcare associated pneumonia within seven days of admission

• Recruitment status: COMPLETED
• Target enrollment: 530 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2020-09-09

Participant Flow

Patients who were admitted to our hospital,Jan 2005 to Dec 2010 The patients with the diagnosis was pneumonia were selected. They were enrolled if they fulfilled the criteria for HCAP defined in 2005 ATS/IDSA

Participant milestones

Measure	PSI II Pneumonia severity index less than 70 or equal to 70, (Pneumonia is more severe if the index is higher)	PSI III Pneumonia severity index 70-90	PSI IV Pneumonia severity index 91-130	PSI V Pneumonia severity index more than 130
Overall Study STARTED	15	51	195	269
Overall Study COMPLETED	15	51	195	269
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Characteristics and Microbiology of Healthcare Associated Pneumonia

Baseline characteristics by cohort

Measure	PSI II n=15 Participants PSI less than 70 or equal to 70	PSI III n=51 Participants PSI 70-90	PSI IV n=195 Participants PSI 90-130	PSI V n=269 Participants PSI more than 130	Total n=530 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	21 Participants n=7 Participants	50 Participants n=5 Participants	17 Participants n=4 Participants	100 Participants n=21 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	30 Participants n=7 Participants	145 Participants n=5 Participants	252 Participants n=4 Participants	430 Participants n=21 Participants
Age, Continuous	49.7 years STANDARD_DEVIATION 12.5 • n=5 Participants	66.4 years STANDARD_DEVIATION 11.7 • n=7 Participants	73.3 years STANDARD_DEVIATION 12.5 • n=5 Participants	79.5 years STANDARD_DEVIATION 10.2 • n=4 Participants	75.1 years STANDARD_DEVIATION 12.8 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	20 Participants n=7 Participants	56 Participants n=5 Participants	100 Participants n=4 Participants	181 Participants n=21 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	31 Participants n=7 Participants	139 Participants n=5 Participants	169 Participants n=4 Participants	349 Participants n=21 Participants
Region of Enrollment Taiwan	15 participants n=5 Participants	51 participants n=7 Participants	195 participants n=5 Participants	269 participants n=4 Participants	530 participants n=21 Participants

PRIMARY outcome

Timeframe: 7 days

sputum culture and sterile specimen such as blood or pleural effusion culture for healthcare associated pneumonia within seven days of admission

Outcome measures

Measure	PSI II n=15 Participants Pneumonia severity index less than 70 or equal to 70, (Pneumonia is more severe if the index is higher)	PSI III n=51 Participants Pneumonia severity index 70-90	PSI IV n=195 Participants Pneumonia severity index 91-130	PSI V n=269 Participants Pneumonia severity index more than 130
Pathogens of Healthcare Associated Pneumonia, Measured by the Number of Participants	15 Participants	51 Participants	195 Participants	269 Participants

PRIMARY outcome

Timeframe: seven days after admission

MDR bacteria were defined as Pseudomonas aeruginosa (P. aeruginosa), Enterobacter species, those not sensitive to second and third generation cephalosporins, Acinetobacter species, extended-spectrum β-lactamase (ESBL) Enterobacteriaceae such as Escherichia coli (E. coli) and Klebsiella pneumoniae (K. pneumoniae), Burkholderia cepacia (B. cepacia), Stenotrophomonas maltophilia (S. maltophilia), and methicillin resistant Staphylococcus aureus (MRSA).

Outcome measures

Measure	PSI II n=15 Participants Pneumonia severity index less than 70 or equal to 70, (Pneumonia is more severe if the index is higher)	PSI III n=51 Participants Pneumonia severity index 70-90	PSI IV n=195 Participants Pneumonia severity index 91-130	PSI V n=269 Participants Pneumonia severity index more than 130
Number of Participants With MDR Pathogens MDR	1 participants	13 participants	72 participants	120 participants
Number of Participants With MDR Pathogens mortality	0 participants	3 participants	24 participants	64 participants

Adverse Events

PSI II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PSI III

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PSI IV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PSI V

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	PSI II PSI less than 70 or equal to 70	PSI III PSI 70-90	PSI IV PSI 90-130	PSI V PSI more than 130
Investigations Serious adverse event	— 0/0 It was a retrospective observational study. No intervention was done during this study. Thereafter, no serious adverse event was assessed.	— 0/0 It was a retrospective observational study. No intervention was done during this study. Thereafter, no serious adverse event was assessed.	— 0/0 It was a retrospective observational study. No intervention was done during this study. Thereafter, no serious adverse event was assessed.	— 0/0 It was a retrospective observational study. No intervention was done during this study. Thereafter, no serious adverse event was assessed.

Other adverse events

Measure	PSI II PSI less than 70 or equal to 70	PSI III PSI 70-90	PSI IV PSI 90-130	PSI V PSI more than 130
Investigations non-serious adverse event	— 0/0 It was a retrospective observational study. No intervention was done during this study. Thereafter, no serious adverse event was assessed.	— 0/0 It was a retrospective observational study. No intervention was done during this study. Thereafter, no serious adverse event was assessed.	— 0/0 It was a retrospective observational study. No intervention was done during this study. Thereafter, no serious adverse event was assessed.	— 0/0 It was a retrospective observational study. No intervention was done during this study. Thereafter, no serious adverse event was assessed.

Additional Information

Dr. Ping-huai Wang

Far Eastern Memorial hospital

Phone: 886-2-89667000

Email: pinghuaiwang@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place