Ciprofloxacin pharmacokinetics after IV and oral administration in cachectic elderly patients

Phase 4

Completed

• Conditions: cystitis; Pneumonia; Urinary tract infection; 10004018

• Registration Number: NL-OMON50150
• Lead Sponsor: Tergooiziekenhuizen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

- Treated witch ciprofloxacin as a part of routine clinical care
- >75 years of age
- At least one of the following:
o BMI <19
o Unintended weight loss of >10% of total body weight in the previous 12 months
o weight <60kg and BMI<21
o BMI <21 and a positive MUST score for malnutrition
- Participant is able and willing to sign the Informed consent before screening
evaluations.

Exclusion Criteria

- Subjects may not be critically ill, i.e. not be admitted to the ICU

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A farmacokinetic model using Non Linear Mixed Effects Modelling (NONMEM). Model<br /><br>validation using bootstrap<br /><br>method or Sampling lmportance Resampling (SlR). The final modelwill be used for<br /><br>Monte Carlo simulation for multipledosing<br /><br>regimens and higher dosages.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>