Usage of Meropenem/Gentamicin Versus Ceftazidime/Avibactam in ARDS

Ventilator Associated Pneumonia Clinical Trial

Official title:

Comparative Study Between Usage of Meropenem/Gentamicin Versus Ceftazidime/Avibactam in the Treatment of ARDS Induced by Both Lung Trauma and VAP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04402359
• Other study ID #: ICU-3-20
• Status: Completed
• Start date: July 5, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2020
• Source: King Abdul Aziz Specialist Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This was a prospective double blind study conducted on 200 polytrauma patients admitted to King Abdul-Aziz Specialized Hospital, Taif, KSA between July 2018 and December 2019 in surgical ICU. All patients were having severe chest trauma, contused lungs either with or without severe head trauma.

Description:

Patients of Group A received meropenem one gram slowly IV infusion every 8 hours for 14 days and gentamicin 7 milligram (mg)/ Kilogram body weight per day slowly IV infusion once daily only for one week, while patients of Group B received ceftazidime 2 grams and avibactam 500 mg every 8 hours for 14 days in solution for injection(sodium chloride 9 mg/mL (0.9%), sodium chloride 4.5 mg/mL, dextrose 25 mg/mL, 0.45% sodium chloride, 2.5% dextrose and/or Lactated Ringer's solution). The solution for injection should be administered over 120 minutes. • Temperature was measured every 3 hours for 2 weeks. • ABG was done every 8 hours for 2 weeks. • CBC including white cell count was done daily and for 2 weeks. • Complete renal functions daily (urea and creatinine serum level) for 2 weeks. Any patient showing rise in the creatinine level was recorded and excluded from the study. • Chest X-ray for all the patients was ordered after intubation and with onset of ventilation and every 24 hours for 2 weeks. • All patients received anti-stress (Omeprazole 20 mg IV every 12 hours). • Oro-gastric tubes were inserted to all patients and feeding was started within 24 hours.Daily evaluation for conscious level and need for sedation and ventilation were done for all patients. • Tracheobronchial lavage was obtained by bronchoscopy 2 times a week and sent for qualitative culture for 2 weeks. • Blood culture was also taken 2 times per week for 2 weeks. • The planned duration of the study is two weeks from diagnosis of VAP and starting the antibiotics so any patients who failed to be weaned within this period were considered morbidity and recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 30, 2019
• Est. primary completion date: December 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria

patients with respiratory failure diagnosed by ABG,chest Xray, and clinical by Arterial oxygen low saturation.

Exclusion Criteria:

• Any other types of respiratory failure rather than trauma

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Drug:
• meropenem
meropenem one gram slowly IV infusion every 8 hours for 14 days
• ceftazidime 2 grams and avibactam 500
received ceftazidime 2 grams and avibactam 500 mg every 8 hours for 14 days in solution for injection(sodium chloride 9 mg/mL (0.9%), sodium chloride 4.5 mg/mL, dextrose 25 mg/mL, 0.45% sodium chloride, 2.5% dextrose and/or Lactated Ringer's solution).

Device:
• ventilator
all patients selected to be ventilated for 14 days

Locations

Country	Name	City	State
Saudi Arabia	King abd el Aziz specialist hospital	Ta'if

Sponsors (1)

Lead Sponsor	Collaborator
King Abdul Aziz Specialist Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systemic change of tissue oxygenation	improvement of arterial partial pressure of oxygen	2 weeks