Usage of Meropenem/Gentamicin Versus Ceftazidime/Avibactam in ARDS

NCT04402359 | Completed DMC FDA Drug

• 1 other identifier: ICU-3-20
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• systemic change of tissue oxygenation

  improvement of arterial partial pressure of oxygen

  2 weeks

Study Arms (2)

Group A

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 after ventilator for 2 weeks

Drug: meropenem; Device: ventilator

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.after ventilator for 2 weeks

Drug: ceftazidime 2 grams and avibactam 500; Device: ventilator

Interventions

meropenem DRUG

meropenem one gram slowly IV infusion every 8 hours for 14 days

Group A

ceftazidime 2 grams and avibactam 500 DRUG

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).

Also known as: Avycaz

Group B

ventilator DEVICE

all patients selected to be ventilated for 14 days

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

200 polytrauma patients admitted to King Abdul-Aziz Specialized Hospital, Taif, KSA between July 2018 and December 2019 in surgical ICU.

You may qualify if:

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

You may not qualify if:

• Any other types of respiratory failure rather than trauma

Sponsors & Collaborators

• King Abdul Aziz Specialist Hospital: lead

Study Sites (1)

King abd el Aziz specialist hospital

Ta'if, 21944, Saudi Arabia

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Meropenem; avibactam, ceftazidime drug combination; Ventilators, Mechanical

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: July 5, 2018
• Primary Completion: December 28, 2019
• Study Completion: December 30, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)