Feasibility of Centralized Therapeutic Drug Monitoring of Fluoroquinolones in Multi-Drug Resistant Tuberculosis Patients (PERFECT)

University Medical Center Groningen (UMCG)

Status: Unknown

Conditions: Tuberculosis, Multidrug-Resistant

Treatments: Procedure: Centralized Therapeutic Drug Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT03409315

CTDM/FQ1

Details and patient eligibility

About

Observational, multi-centre, prospective study to investigate the feasibility of centralized TDM of moxifloxacin and levofloxacin in MDR-TB patients by determining turn-around time between sampling and receiving dosing advice.

In addition, the effect of TDM will be evaluated by comparing treatment results of prospective patients receiving TDM with historical controls without TDM.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pulmonary MDR-TB
• Sputum smear and sputum culture positive at baseline
• Oral administration of either moxifloxacin or levofloxacin
• Written informed consent (for use of the medical data)

Exclusion criteria

• Pregnancy or breast feeding

Trial design

360 participants in 4 patient groups

Moxifloxacin, prospective

Description:

Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of moxifloxacin.

Treatment:

Procedure: Centralized Therapeutic Drug Monitoring

Levofloxacin, prospective

Description:

Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of levofloxacin

Treatment:

Procedure: Centralized Therapeutic Drug Monitoring

Moxifloxacin, historical controls

Description:

Historical controls (n=120) matched to prospective patients, did not receive centralized therapeutic drug monitoring of moxifloxacin.

Levofloxacin, historical controls

Description:

Historical controls (n=120) matched to prospective patients, did not receive centralized therapeutic drug monitoring of levofloxacin.