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CompletedNCT01944319Updated Feb 25, 2016Results posted

Meropenem Dosage Strategy Based on PPK Model

A Phase 4 interventional study of Routine meropenem therapy and Meropenem therapy based on a PPK and PD model in Lower Respiratory Tract Infection, sponsored by Qingtao Zhou. Completed at 1 site in China. Open to participants aged 60 Years to 95 Years. Per ClinicalTrials.gov, last updated 2016-02-25.

Sponsored by Qingtao Zhou · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
60 Years to 95 Years
Sex
All
01

Study 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.

Read the detailed description
  • Subjects:lower respiratory tract infection patients
  • Study design:randomized control study.The patients in study group will accept meropenem therapy with the regimen decided by a software developed from a PPK-PD model. The patients in control group will accept meropenem therapy with the regimen decided by attending physician.
  • Primary endpoint: clinical successful rate of meropenem therapy. The clinical efficiency of meropenem therapy will be evaluated one week later from stop of meropenem therapy.
  • Second endpoint: amount of used antibiotics and bacteriological successful rate.
02

Conditions studied

  • Lower Respiratory Tract Infection

Keywords

  • Infection; Meropenem; Pharmacokinetics; Pharmacodynamics
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 79 is below the median of 120 across 4,201 interventional studies indexed under Infections.

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Lead sponsor

This is the only study on the registry with Qingtao Zhou as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
79 participants (actual)

Study arms

  • Active comparator
    Control group

    The participants in control group will accept routine meropenem therapy

    Drug: Routine meropenem therapy

  • Experimental
    Study group

    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

  • DrugRoutine meropenem therapy

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

    Also known as: Standard care

  • DrugMeropenem therapy based on a PPK and PD model

    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

06

What researchers measure

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.

    Time frame: One week after antibiotic therapy finished.

Secondary outcomes

  1. Amount of Used Antibiotics

    Record the amount of antibiotics usage during antibiotic therapy

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

  2. Bacteriological Success Rate

    The bacterial success or failure will be evaluated at the end of meropenem therapy. Bacteriological success including eradication and presumed eradication. Bacteriological failure including persistence and presumed persistence.

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

07

Results

Posted Feb 25, 2016

Participant flow

Participant flow — Overall Study
MilestoneControl GroupStudy Group
Started4039
Completed4039
Not completed00

Outcome measures

PrimaryClinical 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.

Time frame:
One week after antibiotic therapy finished.
Reported as:
Number · participants
Clinical Success Rate
participantsControl GroupStudy Group
Clinical Success Rate2835
SecondaryAmount of Used Antibiotics

Record the amount of antibiotics usage during antibiotic therapy

Time frame:
participants will be followed for the duration of antibiotic therapy, an average of 10 days
Reported as:
Median · grams
Amount of Used Antibiotics
gramsControl GroupStudy Group
Amount of Used Antibiotics19.0 (12.0 to 29.5)15.0 (7.5 to 24.0)
SecondaryBacteriological Success Rate

The bacterial success or failure will be evaluated at the end of meropenem therapy. Bacteriological success including eradication and presumed eradication. Bacteriological failure including persistence and presumed persistence.

Time frame:
At the end of meropenem therapy, an average of 10 days.
Reported as:
Number · participants
Bacteriological Success Rate
participantsControl GroupStudy Group
Bacteriological Success Rate2428

Adverse events

Collected over 1 month. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control Group—4/40 (10%)0/40 (0%)
Study Group—0/39 (0%)0/39 (0%)
Most frequent serious events
Most frequent serious events
EventControl GroupStudy Group
DeathVascular disorders4/400/39

Baseline characteristics

Age, Continuous
Age, Continuous(years)Control GroupStudy GroupTotal
Median79 (74 to 87)78 (76 to 84)79 (76 to 85)
Sex: Female, Male
Sex: Female, Male(Participants)Control GroupStudy GroupTotal
Female161026
Male242953
Region of Enrollment
Region of Enrollment(participants)Control GroupStudy GroupTotal
China403979
08

Study locations

1 site
  • Peking University Third Hospita
    Haidian District, Beijing 100191, China
09

References and documents

Publications

  • 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. PubMed 28097633 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01944319
Lead sponsor
Qingtao Zhou
Responsible party
Qingtao Zhou (Associate professor, Peking University Third Hospital) — Sponsor-investigator
First posted
Sep 17, 2013
Start date
Jul 2013
Primary completion
Oct 2015
Completion
Oct 2015
Results posted
Feb 25, 2016
Last update
Feb 25, 2016

Study contacts

Qingtao Zhou, M.D.
principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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