Pneumonia obtained by mechanical ventilation: investigation whether adding inhalation antibiotics with tobramycin to standard intravenous antibiotic treatment is better than intravenous antibiotic treatment alone

• Register: EUCTR
• Last refreshed on: 16 February 2015
• Main ID: EUCTR2014-001406-17-NL
• Date of registration: 05/08/2014
• Prospective Registration: Yes
• Primary sponsor: Erasmus MC
• Public title: Pneumonia obtained by mechanical ventilation: investigation whether adding inhalation antibiotics with tobramycin to standard intravenous antibiotic treatment is better than intravenous antibiotic treatment alone
• Scientific title: Ventilator Associated Pneumonia: addition of Tobramycin Inhalation antibiotic treatment to standard IV antibiotic treatment
• Date of first enrolment: 21/01/2015
• Target sample size: 84
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001406-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Netherlands

Contacts

• Name: research longziekten
• Affiliation: Erasmus MC

• Name: research longziekten
• Affiliation: Erasmus MC

Key inclusion & exclusion criteria

Inclusion criteria:
The clinical suspicion of pneumonia is based on the ATS criteria:
- new or progressive radiologic pulmonary infiltrate
Together with at least two of the following three criteria:
- temperature >38°C
- leukocytosis >12,000/mm3 or leucopenia <4,000/mm3
- purulent respiratory secretions

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion criteria:
patients with allergy to tobramycin; pregnancy; expected to die within 72
hours after enrollment



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

ICU patients with ventilator-associated pneumonia

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Trade Name: Bramitob
Product Name: Bramitob
Product Code: 033841
Pharmaceutical Form: Inhalation vapour, solution
Pharmaceutical form of the placebo: Inhalation vapour, solution
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Primary end point(s): Nonresponse is considered when at least one of the following criteria is present:
(1) No improvement of the arterial O2 tension to inspired O2 fraction ratio
(2) Persistence of fever (=38°C) or hypothermia (<35.5°C) together with purulent
respiratory secretions
(3) increase in the pulmonary infiltrates on chest radiograph of greater than or equal to 50%
(4) occurrence of septic shock or multiple organ dysfunction syndrome, defined as three or more organ system failures not present on Day 1

Secondary Objective: Does addition of inhalation tobramycin to standard IV treatment result in a lower mortality and shorter length of stay than standard IV antibiotic treatment alone in patients with ventilator-associated pneumonia.

Does addition of inhalation tobramycin to standard IV treatment result in an improved bacterial eradication rate than standard IV antibiotic treatment alone in patients with ventilator-associated pneumonia.

In case of non-response at day 4, what are the causes of non-response?

Timepoint(s) of evaluation of this end point: The initial response to treatment will be evaluated after 3 days of antimicrobial treatment.

Main Objective: Does addition of inhalation tobramycin to standard IV treatment result in a higher clinical cure rate than standard IV antibiotic treatment alone in patients with ventilator-associated pneumonia.
The initial response to treatment will be evaluated after 3 days of antimicrobial treatment.

Secondary Outcome(s)

Secondary end point(s): - 30-day and 90- day mortality rate
- ICU survival
- Number of days without mechanical ventilation
- length of stay
- discharge from the ICU
- duration of mechanical ventilation
- adverse events
- day of normalisation of CRP, procalcitonin (PCT) and chest X-ray
- eradication of pathogens (especially pseudomonas)
- Clinical Pulmonary Infectious Score (31); APACHE II score; multiple organ dysfunction score (MODS)
- Cytokine response
- Causes of nonresponse. In patients with initial nonresponse to treatment, cultures of respiratory samples and blood will be obtained again, and the empiric antimicrobial treatment will be revised

Timepoint(s) of evaluation of this end point: The initial response to treatment will be evaluated after 3 days of antimicrobial treatment.
and at day 8, 14, discharge ICU, discharge hospital, Day 30, Day 90

Secondary ID(s)

48009

Source(s) of Monetary Support

Erasmus MC