Antibiotics Continuous Infusion at Home (TAID)

March 24, 2021 updated by: Vittorio Montefusco, Ospedale San Carlo Borromeo

TAID Study - A Prospective Interventional Trial on Antibiotics Continuous Infusion at Home

BACKGROUND: The spread of multidrug-resistant bacteria represents a well-known problem, which must be face up by optimizing antibiotic therapy both in terms of choosing the most appropriate drug and of an adequate treatment duration. The method of administration is also a critical element. There are data relating to the maximization of the efficacy of Carbapenems and Piperacillin/Tazobactam by continuous infusion, able to constantly maintain adequate drug concentrations. Several studies, conducted comparing a standard administration of Carbapenem or Piperacillin/Tazobactam to an extended administration or continuous perfusion to evaluate safety and efficacy in terms of mortality reduction, have been documented. The achievement of optimal serum concentrations during continuous infusion has been documented both for Carbapenems and Piperacillin/Tazobactam, and for other types of antibiotics such as Cefepime and Vancomycin. The duration of antibiotic treatment is a critical factor for the prevention of relapses as well as the onset of resistance. The recommended duration of antibiotic treatment varies according to the site of infection and the type of pathogen and is generally between 7 and 14 days, however, in particular cases it is possible that the administration of antibiotics must be longer than one month. In general, the length of hospitalization is associated with a greater likelihood of complications for patients, with a substantial increase in the risk of developing multiple types of complications, such nosocomial infections, bed rest, bedsores, falls, malnutrition and disorientation. It should also be noted that prolonged hospitalization leads to a substantial increase in care costs. The advantage in terms of greater therapeutic success linked to the continuous infusion of some types of antibiotics has been used for the development of home infusion protocols for antibiotic therapy. There are numerous studies that show the feasibility and effectiveness of home infusion antibiotic therapy using elastomeric devices, documenting its substantial equivalence with respect to hospital treatment. The antibiotics for which there is evidence of feasibility are various, including Cefepime, Vancomycin and Piperacillin/Tazobactam.

STUDY DESIGN: The study is aimed to patients with severe bacterial infections who have started an antibiotic treatment and are benefiting from such therapy. The purpose of the study is to move the continuation of antibiotic therapy to the home setting once its efficacy and tolerability during hospitalization have been documented, in order to allow the patient a potentially eradicating treatment, of adequate duration without the need of hospitalization. Patients are enrolled when the efficacy and tolerability of the ongoing antibiotic treatment based on Cefepime, Meropenem, Piperacillin/Tazobactam or Vancomycin has been documented. The protocol requires that the patient go to the hospital every morning to replace the elastomer and to carry out a medical examination. Blood chemistry tests, which include at least blood counts, electrolytes, renal function, liver function and inflammation indices are scheduled to be performed at least once a week. Exams can also be done more frequently based on clinical needs. Antibiotic therapy should be carried out until the infection is cured, as per current clinical practice. For the purposes of the study, the patient remains under observation for 30 days after enrollment. Blood samples for the assessment of antibiotic concentrations will be performed in correspondence with the blood chemistry tests performed routinely for patient assessment. In any case, for each patient, a sample is taken for the dosage of the antibiotic used, which will be a single sample in the event of a continuous infusion, or a downstream sample (within one hour of the new antibiotic administration) and peak (30 minutes after the end of the infusion). The pharmacokinetic sampling relating to the outpatient phase will be carried out on the third or fourth day of continuous infusion therapy at the time of the elastomer change.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

STATISTICAL ANALYSIS: This is an interventional monocentric study. The primary endpoint of the study is a reduction in hospitalization days. The study population is divided into 4 treatment arms: assuming that the average length of hospitalization for the standard treatment of a severe infection, for each of the types of antibiotic studied, is 14 days, with the treatment envisaged by the study it is assumed to reduce this duration,for all 4 treatment arms, to a number equal to or less than 12 days. With these premises, applying the One sample t-test design method, assuming α = 0.05 and β = 0.1, the number of patients expected is 9 for each treatment arm. Considering a 30% dropout, the total population to be enrolled for each type of antibiotic is 12 patients. In total, the study will enroll 48 patients. The study provides for an observation period of 30 days from enrollment. During this period, efficacy, safety and pharmacokinetic data will be collected for each treatment arm.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20153
        • ASST Santi Paolo Carlo - San Carlo Borromeo Hospital - SSd Onco-Hematology
        • Principal Investigator:
          • Vittorio Montefusco, MD
        • Contact:
          • Vittorio Montefusco, MD
        • Principal Investigator:
          • Teresa Bini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18 to 90 years.
  • Ability to understand and sign informed consent.
  • Treatment infection responsive to Cefepime, Meropenem or Piperacillin / Tazobactam, Vancomycin.
  • Absence of allergies to Cefepime, Meropenem or Piperacillin / Tazobactam, Vancomycin.
  • Evidence of clinical response to treatment with Cefepime, Meropenem or Piperacillin / Tazobactam, Vancomycin and at least 3 days of apyrexia with current infusion antibiotic therapy.
  • Good tolerance to ongoing antibiotic treatment with Cefepime, Meropenem or Piperacillin / Tazobactam, Vancomycin.

Exclusion Criteria:

  • Inability for any reason (e.g. absence of caregiver) to manage the elastomeric pump and access the hospital on a daily basis.
  • Lack of adequate venous access.
  • Inability to hydrate themselves properly orally.
  • Infection involving the central nervous system.
  • Creatinine> 2 mg / dL.
  • Neutrophil granulocytes ≤ 1000 / µL.
  • Platelets ≤ 20000 / µL.
  • "aspartate amino transferase" and "alanine amino transferase" > 100 U / L.
  • Bilirubin> 3 mg / dL.
  • Presence of any comorbidities that, in the opinion of the physician, could compromise the safe execution of antibiotic home continuous infusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A - Cefepime
Continuous infusion of Cefepime at home.
Drug: Cefepime
Cefepime from 3 to 6 gr, based on patient's clinical status, reduced dose based on organ function and physician discretion, in 100cc saline solution in elastomer, perfused in 24 hours.
Experimental: Arm B - Piperacillin/tazobactam
Continuous infusion of Piperacillin/tazobactam at home.
Drug: Piperacillin/tazobactam
Piperacillin/Tazobactam 18 gr, based on patient's clinical status, reduced dose based on organ function and physician discretion, in 100cc saline solution in elastomer, perfused in 24 hours.
Experimental: Arm C - Meropenem
Continuous infusion of meropenem at home.
Drug: Meropenem
Meropenem 3 gr, based on patient's clinical status, reduced dose based on organ function and physician discretion, in 100cc saline solution in elastomer, perfused in 24 hours.
Experimental: Arm D - Vancomycin
Continuous infusion of vancomycin at home.
Drug: Vancomycin
Vancomycin 30 mg/kg, based on patient's clinical status, reduced dose based on organ function and physician discretion, in 100cc saline solution in elastomer, perfused in 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of hospitalization days for the treatment of severe bacterial infections
Time Frame: 14 days
The number of hospitalization days for the treatment of severe bacterial infections with continuous infusion antibiotics at home will be compared with the number of hospitalization days for standard antibiotics therapies for severe bacterial infections.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of antibiotic treatment
Time Frame: 30 days from the enrollment
The effectiveness of antibiotic treatment in continuous infusion at home will be compared with the effectiveness of antibiotic standard treatment in terms of the number of patients that have to start a new antibiotic line therapy.
30 days from the enrollment
Number of new hospitalizations days for the same problem in the month following the start of home continuous infusion therapy.
Time Frame: 30 days from the enrollment
The number of new hospitalizations days for the same problem in the month following the start of continuous infusion antibiotic therapy at home will be compared with the number of new hospitalizations for the same problem with antibiotic standard treatment.
30 days from the enrollment
Ongoing adverse events of home continuos infusion therapy.
Time Frame: 30 days from the enrollment
The number of adverse events of each grade will be quantified.
30 days from the enrollment
Adverse events related to the presence of a venous access
Time Frame: 30 days from the enrollment
The number of adverse events related to the presence of a venous access will be quantified.
30 days from the enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Carlo Borromeo

Collaborators

Associazione Oncologica Milanese AmoLaVita ONLUS

Investigators

  • Principal Investigator: Vittorio Motefusco, MD, Ospedale San Carlo Borromeo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAID Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Severe Bacterial Infections

Clinical Trials on Cefepime

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe