Meropenem Dosage Strategy Based on PPK Model

Lower Respiratory Tract Infection Clinical Trial

Official title:

Clinical Evaluation of a Meropenem Dosage Strategy Based on a Population Pharmacokinetic-pharmacodynamic Model in Lower Respiratory Tract Infection Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944319
• Other study ID #: 75505-01
• Status: Completed
• Phase: Phase 4
• First received: July 2, 2013
• Last updated: January 28, 2016
• Start date: July 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 95 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Lower Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

Drug:
• Routine meropenem therapy
Participants in control group will accept meropenem therapy with regimen routinely decided by attending physician
• 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

Locations

Country	Name	City	State
China	Peking University Third Hospita	Haidian District	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Qingtao Zhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Amount of Used Antibiotics	Record the amount of antibiotics usage during antibiotic therapy	participants will be followed for the duration of antibiotic therapy, an average of 10 days	Yes
Secondary	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.	At the end of meropenem therapy, an average of 10 days.	Yes