Meropenem Dosage Strategy Based on PPK Model

NCT01944319 | Completed Phase 4 Results DMC

• 1 other identifier: 75505-01
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the clinical and economical benefits of a meropenem dosage strategy based on a population pharmacokinetic(PPK)-pharmacodynamic(PD) model in lower respiratory tract infection patients.

Conditions

Lower Respiratory Tract Infection

Keywords

Infection; Meropenem; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Clinical Success Rate

  The clinical success or failure of meropenem therapy will be evaluated one week after stop of antibiotic therapy. Clinical success was defined as cure or improvement of all signs and symptoms caused by the infection and no requirement for additional antibacterial therapy. Clinical failure was defined as a persistence or worsening of any new clinical sign or symptom, development of any new clinical signs or symptoms of infection, or the requirement for other systemic antimicrobial therapy at the end of meropenem therapy.

  One week after antibiotic therapy finished.

Secondary Outcomes (2)

• Amount of Used Antibiotics

  participants will be followed for the duration of antibiotic therapy, an average of 10 days

• Bacteriological Success Rate

  At the end of meropenem therapy, an average of 10 days.

Study Arms (2)

Control group

ACTIVE COMPARATOR

The participants in control group will accept routine meropenem therapy

Drug: Routine meropenem therapy

Study group

EXPERIMENTAL

The participants in study group will accept meropenem therapy based on a PPK and PD model.

Drug: Meropenem therapy based on a PPK and PD model

Interventions

Routine meropenem therapy DRUG

Participants in control group will accept meropenem therapy with regimen routinely decided by attending physician

Also known as: Standard care

Control group

Meropenem therapy based on a PPK and PD model DRUG

Participants in study group will accept meropenem therapy based on a software developed from a PPK and PD model

Also known as: Experimental meropenem therapy

Study group

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sixty years and older patients hospitalized at the Peking University Third Hospital with community-acquired or hospital-acquired lower respiratory tract infection.
• Bacilli was idolated from lower respiratory tract specimens within 48 hours prior to study enrollment.
• The pathogen was sensitive to meropenem.
• Received broad-spectrum antibiotic therapy less than 24 hours, or no improvement after antibiotic therapy and pathogen was resistant to the used antibiotics.

You may not qualify if:

• Had documented hypersensitivity to carbapenems.
• More than one pathogenic Gram-negative bacillus was isolated lower respiratory tract specimens.
• Positive HIV antibody titre.
• Had known or suspected tuberculosis or other infections caused by Gram-positive cocci, viruses or fungi at baseline.

Sponsors & Collaborators

• Qingtao Zhou: lead

Study Sites (1)

Peking University Third Hospita

Haidian District, Beijing Municipality, 100191, China

Location

Related Publications (1)

• Zhou QT, He B, Shen N, Liang Y, Sun LN. Meropenem Dosing Based on a Population Pharmacokinetic-Pharmacodynamic Model in Elderly Patients with Infection of the Lower Respiratory Tract. Drugs Aging. 2017 Feb;34(2):115-121. doi: 10.1007/s40266-016-0431-9.

  PMID: 28097633 DERIVED

MeSH Terms

Conditions

Infections

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Qingtao ZHOU
• Organization: Peking University Third Hospital

zhouqingtaobysy@sina.com

86-10-82265562

Study Officials

• Qingtao Zhou, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: September 17, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 25, 2016
• Results First Posted: February 25, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)