PERFECT: Feasibility of Centralized Therapeutic Drug Monitoring of Fluoroquinolones in Multi-Drug Resistant Tuberculosis Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Moxifloxacin, prospective Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of moxifloxacin. |
Procedure: Centralized Therapeutic Drug Monitoring
Plasma samples will be drawn at peripheral centres en shipped to a central laboratory for analysis. Results and dosing advice will be returned by email to local physician.
|
| Levofloxacin, prospective Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of levofloxacin |
Procedure: Centralized Therapeutic Drug Monitoring
Plasma samples will be drawn at peripheral centres en shipped to a central laboratory for analysis. Results and dosing advice will be returned by email to local physician.
|
| Moxifloxacin, historical controls Historical controls (n=120) matched to prospective patients, did not receive centralized therapeutic drug monitoring of moxifloxacin. |
|
| Levofloxacin, historical controls Historical controls (n=120) matched to prospective patients, did not receive centralized therapeutic drug monitoring of levofloxacin. |
Outcome Measures
Primary Outcome Measures
- Feasibility of centralized TDM [1 week]
Turn-around time between plasma sampling and receiving dosing advice
Secondary Outcome Measures
- Impact of centralized TDM [2 months]
Comparison of % patients with converted sputum smear and culture between prospective patients with TDM and matched historical controls without TDM (1:2)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Prince Charles and Caboolture Hospitals | Brisbane | Australia | ||
| 2 | Republican Scientific and Practical Centre of Pulmonology and Tuberculosis | Minsk | Belarus | ||
| 3 | Hélio Fraga Reference Center | Rio De Janeiro | Brazil | ||
| 4 | Athens Chest Hospital "Sotiria" | Athens | Greece | ||
| 5 | Alma Mater Studiorum University of Bologna | Bologna | Italy | ||
| 6 | Reuh Tldc | Upeslejas | Latvia | ||
| 7 | Instituto Nacional de Enfermedades Respiratorias | Mexico City | Mexico | ||
| 8 | University Medical Center Groningen Beatrixoord | Haren | Netherlands | ||
| 9 | Vila Nova Gaia/Espinho Medical School | Vila Nova De Gaia | Portugal | ||
| 10 | University of Cape Town, Lung Insitute | Cape Town | South Africa | ||
| 11 | Karolinska University Hospital | Stockholm | Sweden | ||
| 12 | Kibong'oto Infectious Diseases Hospital | Sanya Juu | Tanzania | ||
| 13 | Royal London Hospital | London | United Kingdom |
Sponsors and Collaborators
- University Medical Center Groningen
Investigators
- Principal Investigator: Jan-WIllem Alffenaar, PhD, UMCG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTDM/FQ1