Trial Outcomes & Findings for Aerosolized Antibiotics in the Treatment of Ventilator Associated Pneumonia (NCT NCT02478710)

NCT ID: NCT02478710

Last Updated: 2023-05-31

Results Overview

Recurrence after a second bronchoalveolar lavage (BAL) reveals at least one bacterial species growing at concentrations of greater than 10 to the fourth power organisms during the time period of 9-21 days after initiating therapy.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: 9-21 days after initiating antibiotic therapy
• Results posted on: 2023-05-31

Participant Flow

Participant milestones

Measure	Aerosolized Placebo Placebo tobramycin 0.5 mL 0.9% normal saline q.12h. Placebo vancomycin 0.5 mL 0.9% normal saline q.8h. Aerosolized Placebo: Placebo tobramycin: 5 ml 0.9% normal saline q. 12h. Placebo vancomycin: 5m 0.9% normal saline q. 8 hr.	Aerosolized Tobramycin or Vancomycin Aerosolized tobramycin 300 mg diluted in 5 mL 0.9% normal saline q.12h. Aerosolized vancomycin 125 mg diluted in 5 mL 0.9% normal saline q.8h. Aerosolized Tobramycin or Vancomycin: Tobramycin: 300 mg diluted in 5 mL of 0.9% normal saline q.12h. Vancomycin: 125 mg diluted in 5 mL 0.9% normal saline q.8h.
Overall Study STARTED	10	6
Overall Study COMPLETED	10	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Aerosolized Placebo n=10 Participants Placebo tobramycin 0.5 mL 0.9% normal saline q.12h. Placebo vancomycin 0.5 mL 0.9% normal saline q.8h. Aerosolized Placebo: Placebo tobramycin: 5 ml 0.9% normal saline q. 12h. Placebo vancomycin: 5m 0.9% normal saline q. 8 hr.	Aerosolized Tobramycin or Vancomycin n=6 Participants Aerosolized tobramycin 300 mg diluted in 5 mL 0.9% normal saline q.12h. Aerosolized vancomycin 125 mg diluted in 5 mL 0.9% normal saline q.8h. Aerosolized Tobramycin or Vancomycin: Tobramycin: 300 mg diluted in 5 mL of 0.9% normal saline q.12h. Vancomycin: 125 mg diluted in 5 mL 0.9% normal saline q.8h.	Total n=16 Participants Total of all reporting groups
Age, Customized Age · Under 18	0 Participants n=10 Participants	0 Participants n=6 Participants	0 Participants n=16 Participants
Age, Customized Age · Over 18	10 Participants n=10 Participants	6 Participants n=6 Participants	16 Participants n=16 Participants
Sex: Female, Male Female	2 Participants n=10 Participants	3 Participants n=6 Participants	5 Participants n=16 Participants
Sex: Female, Male Male	8 Participants n=10 Participants	3 Participants n=6 Participants	11 Participants n=16 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Patients who required ≥48 hours of mechanical ventilation	10 Participants n=10 Participants	6 Participants n=6 Participants	16 Participants n=16 Participants
Patients who had a Clinical Pulmonary Infection Score ≥6.	10 Participants n=10 Participants	6 Participants n=6 Participants	16 Participants n=16 Participants

PRIMARY outcome

Timeframe: 9-21 days after initiating antibiotic therapy

Population: Data was not collected.

Recurrence after a second bronchoalveolar lavage (BAL) reveals at least one bacterial species growing at concentrations of greater than 10 to the fourth power organisms during the time period of 9-21 days after initiating therapy.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 8 days after initiation of therapy for pneumonia

Population: data were not collected

Persistence will be defined as the need to continue antibiotic therapy for greater than 7 days. This is reported as the number of participants with persistence of pneumonia.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: Data was not collected. Technical problems with measurement leading to unreliable or uninterpretable data.

number of days not on vent in first 28 days after randomization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: Data not collected

number of days not in ICU after initiation of therapy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: Data not collected.

number of patients treated in each arm who die in ICU within 28 days of initiation of therapy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: Technical problems with measurement leading to unreliable or uninterpretable data.

patients who develop acute kidney injury after randomization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Population: Data not collected. Technical problems with measurement leading to unreliable or uninterpretable data.

multiple organ dysfunction score at randomization and on day 7 of aerosolized antibiotics/placebo treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: Data not collected. Technical problems with measurement leading to unreliable or uninterpretable data.

patients with failure of therapy or persistence who grow resistant organisms after being treated initially

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: Data not collected. Technical problems with measurement leading to unreliable or uninterpretable data.

total days antibiotics administered for pneumonia after randomization

Outcome measures

Outcome data not reported

Adverse Events

Aerosolized Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Aerosolized Tobramycin or Vancomycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aerosolized Placebo n=10 participants at risk Placebo tobramycin 0.5 mL 0.9% normal saline q.12h. Placebo vancomycin 0.5 mL 0.9% normal saline q.8h. Aerosolized Placebo: Placebo tobramycin: 5 ml 0.9% normal saline q. 12h. Placebo vancomycin: 5m 0.9% normal saline q. 8 hr.	Aerosolized Tobramycin or Vancomycin n=6 participants at risk Aerosolized tobramycin 300 mg diluted in 5 mL 0.9% normal saline q.12h. Aerosolized vancomycin 125 mg diluted in 5 mL 0.9% normal saline q.8h. Aerosolized Tobramycin or Vancomycin: Tobramycin: 300 mg diluted in 5 mL of 0.9% normal saline q.12h. Vancomycin: 125 mg diluted in 5 mL 0.9% normal saline q.8h.
Nervous system disorders Serious	10.0% 1/10 • Number of events 1 • 1 year Current IRB protocol contains an erroneous exclusion criteria "Cervical spine injury with neurological deficit". Consequently and inadvertently, two subjects (002 \& 011) were screened with cervical injuries and neurological deficits but screen failed out and never enrolled. One subject 004 did enroll but we have documented on the physical exam that the patient had cervical spine injury with "no neurological deficits appreciate" which permits inclusion.	0.00% 0/6 • 1 year Current IRB protocol contains an erroneous exclusion criteria "Cervical spine injury with neurological deficit". Consequently and inadvertently, two subjects (002 \& 011) were screened with cervical injuries and neurological deficits but screen failed out and never enrolled. One subject 004 did enroll but we have documented on the physical exam that the patient had cervical spine injury with "no neurological deficits appreciate" which permits inclusion.

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Research

Premier Health

Phone: 19374747850

Email: jllader@premierhealth.com

Results disclosure agreements

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