Meropenem Dosage Strategy Based on PPK Model

• Sponsor: Qingtao Zhou (Other)
• Overall Status: Completed
• CT.gov ID: NCT01944319
• Collaborator: (none)
• Enrollment: 79
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Respiratory Tract Infection	Drug: Routine meropenem therapy; Drug: Meropenem therapy based on a PPK and PD model	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of a Meropenem Dosage Strategy Based on a Population Pharmacokinetic-pharmacodynamic Model in Lower Respiratory Tract Infection Patients
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group The participants in control group will accept routine meropenem therapy	Drug: Routine meropenem therapy; Participants in control group will accept meropenem therapy with regimen routinely decided by attending physician; Other Names: Standard care
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; Participants in study group will accept meropenem therapy based on a software developed from a PPK and PD model; Other Names: Experimental meropenem therapy

Outcome Measures

Primary Outcome Measures

1. Clinical Success Rate [One week after antibiotic therapy finished.]

   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.

Secondary Outcome Measures

1. Amount of Used Antibiotics [participants will be followed for the duration of antibiotic therapy, an average of 10 days]

   Record the amount of antibiotics usage during antibiotic therapy

2. Bacteriological Success Rate [At the end of meropenem therapy, an average of 10 days.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 95 Years
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Third Hospita	Haidian District	Beijing	China	100191

Sponsors and Collaborators

• Qingtao Zhou

Investigators

• Principal Investigator: Qingtao Zhou, M.D., Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qingtao Zhou, Associate professor, Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT01944319
• Other Study ID Numbers: 75505-01
• First Posted: Sep 17, 2013
• Last Update Posted: Feb 25, 2016
• Last Verified: Jan 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Qingtao Zhou, Associate professor, Peking University Third Hospital: Infection; Meropenem; Pharmacokinetics; Pharmacodynamics
• Additional relevant MeSH terms: Infections; Respiratory Tract Infections; Meropenem

Study Results

Participant Flow

Arm/Group Title	Control Group	Study Group
Arm/Group Description	Meropenem therapy with regimen routinely decided by attending physician	Patients in Study group will accept meropenem therapy based on PPK and PD parameter. Meropenem therapy based on PPK and PD: Meropenem therapy with regimen decided by a software developed from a PPK model and clinical PD parameter
Period Title: Overall Study
STARTED	40	39
COMPLETED	40	39
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control Group	Study Group	Total
Arm/Group Description	Meropenem therapy with regimen routinely decided by attending physician	Patients in Study group will accept meropenem therapy based on PPK and PD parameter. Meropenem therapy based on PPK and PD: Meropenem therapy with regimen decided by a software developed from a PPK model and clinical PD parameter	Total of all reporting groups
Overall Participants	40	39	79
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	79	78	79
Sex: Female, Male (Count of Participants)
Female	16 40%	10 25.6%	26 32.9%
Male	24 60%	29 74.4%	53 67.1%
Region of Enrollment (participants) [Number]
China	40 100%	39 100%	79 100%

Outcome Measures

1. Primary Outcome

Title	Clinical Success Rate
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Study Group
Arm/Group Description	The participants in control group will accept routine meropenem therapy.	The participants in stusy group will accept meropenem therapy based on a PPK and PD model.
Measure Participants	40	39
Number [participants]	28 70%	35 89.7%

2. Secondary Outcome

Title	Amount of Used Antibiotics
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Study Group
Arm/Group Description	The participants in control group will accept routine meropenem therapy.	The participants in study group will accept meropenem therapy based on a PPK and PD model.
Measure Participants	40	39
Median (Inter-Quartile Range) [grams]	19.0	15.0

3. Secondary Outcome

Title	Bacteriological Success Rate
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Study Group
Arm/Group Description	The participants in control group will accept routine meropenem therapy.	The participants in study group will accept meropenem therapy based on a PPK and PD model.
Measure Participants	40	39
Number [participants]	24 60%	28 71.8%

Adverse Events

Time Frame	1 month
Arm/Group Title	Control Group		Study Group
Arm/Group Description	The participants in control group will accept routine meropenem therapy.		The participants in study group will accept meropenem therapy based on a PPK and PD model.
All Cause Mortality
	Control Group		Study Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Group		Study Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/40 (10%)		0/39 (0%)
Vascular disorders
Death	4/40 (10%)	4	0/39 (0%)	0
Other (Not Including Serious) Adverse Events
	Control Group		Study Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/39 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.