← Back to Search

Piperacillin-tazobactam administered in a prolonged infusion for Infections

Phase 4

Waitlist Available

Research Sponsored by CR-CSSS Champlain-Charles-Le Moyne

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Adults (18 years and older)

* Patients hospitalized at Hôpital Charles-Le Moyne

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the last dose of the intervention, assessed up to 42 days

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This study aims to evaluate the feasibility of an open randomized controlled study which would assess the proportion patients with obesity who will have a favorable pharmacodynamic parameter (i.e. fT\> 100% MIC) after 24 hours of piperacillin-tazobactam administered as a prolonged intermittent infusion compared to a standard infusion.

Eligible Conditions

Obesity
Infections

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Achievement of a prespecified number of patients recruited per month

Proportion of eligible patients relative to the total population who received a piperacillin-tazobactam for the study period

Rate of adherence to the sampling protocol

+1 more

Secondary study objectives

Incidence of adverse events attributed to the intervention

Need of escalation to carbapenems antibiotics

Number of days of piperacillin-tazobactam treatment under study

+2 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Piperacillin-tazobactam administered in a prolonged infusionExperimental Treatment1 Intervention

Piperacillin-tazobactam dose will be administered over 3 hours for piperacillin-tazobactam dosages every 6 hours or over 4 hours for piperacillin-tazobactam dosages every 8 hours.

Group II: Piperacillin-tazobactam administered in a standard infusionActive Control1 Intervention

Piperacillin-tazobactam dose will be administered over 30 minutes for every piperacilline-tazobactam administered in the study (as instructed by the drug's monograph)

0 / 5Eligibility criteria met