Extended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Gram-Negative Infections

Treatments: Drug: Piperacillin/Tazobactam Intermittent infusion; Drug: Piperacillin/Tazobactam Continuous infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04895657

198

Details and patient eligibility

About

Continuous-infusion of piperacillin/tazobactam over 4 hrs instead of 30-minute intermittent dosage regimen has shown observable outcomes. Our objective is to assess whether continuous infusion of piperacillin/tazobactam is superior in terms of efficacy, safety and cost to the intermittent regimen to treat suspected or proved infections due to gram negative bacteria. The setting is Critical Care Medicine Department at Cairo University Hospitals. Methods A prospective randomized comparative study.

Full description

A total of 56 patients were recruited from ICU- Cairo University Hospitals. All adult critically ill patients admitted to Critical Care Medicine Department with suspected or confirmed bacterial infections on admission or during their ICU stay were assessed for inclusion into the study. All patients were subjected to the following: A. Patient's full history: Age, sex ,medical history ,concurrent diseases, concurrent medications

B. Patient evaluation and assessment:

The following were evaluated at baseline and periodically thereafter until day of stopping antibiotic, discharge and/or death :

1. Kidney functions (Serum creatinine, blood urea nitrogen)
2. Liver functions (ALT, AST, Bil D, Bil T, Albumin)
3. Complete blood count
4. Microbiological Evaluation: Cultures and sensitivity tests from suspected site of infection
5. Clinical signs and symptoms of infection documented by the attending physician on patient's medical record
6. APACHE II Variables

Enrollment: 56 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18-74 years
• Expected ICU stay more than 24 hours

Exclusion criteria

• Allergy or potential allergy to the study medications

  • Pregnancy
  • Patients with CrCl< 20 ml/min or on dialysis
  • Cancer patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Piperacillin/Tazobactam Intermittent infusion

Other group

Description:

4.5 gm Piperacillin/Tazobactam I.V intermittent over 30 min. every 8 hours.

Treatment:

Drug: Piperacillin/Tazobactam Intermittent infusion

Piperacillin/Tazobactam Continuous infusion

Other group

Description:

4.5 gm Piperacillin/Tazobactam I.V extended infusion over 4 hours every 8 hours.

Treatment:

Drug: Piperacillin/Tazobactam Continuous infusion