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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01118403
Other study ID # 58222
Secondary ID
Status Withdrawn
Phase Phase 4
First received May 4, 2010
Last updated May 21, 2016
Start date March 2011
Est. completion date March 2011

Study information

Verified date May 2016
Source Hospital Pablo Tobón Uribe
Contact n/a
Is FDA regulated No
Health authority Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Study type Interventional

Clinical Trial Summary

This study seeks to assess whether coma patients really benefit from the use of antibiotics as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in this population group. For this we consider the use of ampicillin sulbactam antibiotic which has a low ability to induce resistance, efficacy and safety observed during the time that has been used, even in patients with neurosurgical pathology, and to be broadly available in our environment.

Our hypothesis is that neurological patients in coma state, requiring mechanical ventilation, the application of antibiotic prophylaxis compared with placebo reduces the incidence of early ventilator-associated pneumonia.


Description:

Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections occur in intensive care units, with frequencies ranging between 15% and 45%, which determine an attributable mortality of 25% to 27%

Patients with compromised state of consciousness brought to mechanical ventilation, have a much higher reported incidence that patients without neurological involvement, reaches between 44 and 70%.

These data have led to plan the implementation of strategies to reduce the incidence of early pneumonia in this population group, to thereby favorably influence the high rates of mortality, morbidity and costs that arise.

Then we design this study to assess whether these patients really benefit from the use of antibiotics as a prophylactic, considering also the high impact that this would have given the high incidence of early ventilator-associated pneumonia in this population group.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients admitted to intensive care units,with score in the Glasgow Coma scale less than nine.

- Requiring mechanical ventilation for more than 48 hours

- Includes all patients with structural or metabolic coma

Exclusion Criteria:

- Pregnant women

- History of allergic reactions to ampicillin sulbactam

- Patients admitted as potential organ donors

- Patients with an indication of antibiotic therapy, or who have received more than 2 doses of any antibiotic previously.

- Hospital stay for more than 48 hours before intubation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Drug:
Sultamicillin
Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution

Locations

Country Name City State
Colombia Hospital Pablo Tobón Uribe Medellín Antioquia

Sponsors (1)

Lead Sponsor Collaborator
Hospital Pablo Tobón Uribe

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia To determine the impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia in patients with altered level of consciousness with a score on the Glasgow Coma Scale less than or equal to 8 and requiring mechanical ventilation for more than 48 hours 2 years No
Secondary Effect of antibiotic prophylaxis versus placebo on the incidence of other infections Compare the effect of antibiotic prophylaxis versus placebo on the incidence of later ventilator-associated pneumonia, as well as in other non-pulmonary infections (catheter sepsis, bacteremia, meningitis, urinary tract infection). 2 years No
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