Trial Outcomes & Findings for Meropenem Dosage Strategy Based on PPK Model (NCT NCT01944319)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

79 participants

Primary outcome timeframe

One week after antibiotic therapy finished.

Results posted on

2016-02-25

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group Meropenem therapy with regimen routinely decided by attending physician	Study Group 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
Overall Study STARTED	40	39
Overall Study COMPLETED	40	39
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Meropenem Dosage Strategy Based on PPK Model

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=40 Participants Meropenem therapy with regimen routinely decided by attending physician	Study Group n=39 Participants 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 n=79 Participants Total of all reporting groups
Age, Continuous	79 years n=5 Participants	78 years n=7 Participants	79 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	29 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment China	40 participants n=5 Participants	39 participants n=7 Participants	79 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Group n=40 Participants The participants in control group will accept routine meropenem therapy.	Study Group n=39 Participants The participants in stusy group will accept meropenem therapy based on a PPK and PD model.
Clinical Success Rate	28 participants	35 participants

SECONDARY outcome

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

Record the amount of antibiotics usage during antibiotic therapy

Outcome measures

Outcome measures
Measure	Control Group n=40 Participants The participants in control group will accept routine meropenem therapy.	Study Group n=39 Participants The participants in stusy group will accept meropenem therapy based on a PPK and PD model.
Amount of Used Antibiotics	19.0 grams Interval 12.0 to 29.5	15.0 grams Interval 7.5 to 24.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Group n=40 Participants The participants in control group will accept routine meropenem therapy.	Study Group n=39 Participants The participants in stusy group will accept meropenem therapy based on a PPK and PD model.
Bacteriological Success Rate	24 participants	28 participants

Adverse Events

Control Group

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Control Group n=40 participants at risk The participants in control group will accept routine meropenem therapy.	Study Group n=39 participants at risk The participants in study group will accept meropenem therapy based on a PPK and PD model.
Vascular disorders Death	10.0% 4/40 • Number of events 4 • 1 month	0.00% 0/39 • 1 month

Other adverse events

Adverse event data not reported

Additional Information

Dr. Qingtao ZHOU

Peking University Third Hospital

Phone: 86-10-82265562

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place