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| Name | Class |
|---|---|
| Republican Scientific and Practical Centre for Pulmonology and TB | UNKNOWN |
| National Institute for Public Health and the Environment (RIVM) | OTHER_GOV |
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This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB).
Patients receive MDR-TB treatment with o.a. Levofloxacin and Capreomycin. At least one week after start of treatment, the PK samples samples will be obtained via an intravenous catheter at 0, 1, 2, 3, 4, 7, and 12 hours after intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PK of Levofloxacin-Capreomycin | Pharmacokinetics (PK) in M/XDR-TB patients receiving at least Levofloxacin and Capreomycin as part of their WHO treatment for M/XDR-TB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacokinetics | Other | multiple blood samples are obtained by means of an indwelling intravenous catheter for calculating PK parameters |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC/MIC ratio of Levofloxacin | The primary outcome parameter is the ratio of the in vitro minimum inhibitory concentration (MIC) to the area under the serum concentration-time curve (AUC) over 24 hours (AUC0-24h ), [AUC0-24h /MIC], after administration of Levofloxacin. | after day 8 of treatment |
| Cmax/MIC ratio of Capreomycin | The primary outcome parameter is the ratio of the in vitro minimum inhibitory concentration (MIC) to the maximum serum concentration, [Cmax/MIC], after administration of Capreomycin. | after day 8 of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of Distribution | Based on the measured drug concentration during the dosing interval and patient characteristics (height, bodyweight and age) the volume of distribution will be calculated | after day 8 of treatment |
| Clearance |
| Measure | Description | Time Frame |
|---|---|---|
| PK-model | A population PK model will be developed using an iterative 2-stage Bayesian procedure. | after day 8 of treatment |
| Limited sampling strategy | Limited sampling strategies were investigated subsequently using a Bayesian analysis. The best possible strategies for will be evaluated by a Bland-Altman analysis for correlation of predicted and observed AUC0-24. |
Inclusion Criteria:
Exclusion Criteria:
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MDR-TB patients
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| Name | Affiliation | Role |
|---|---|---|
| JW C Alffenaar, PhD PharmD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Republican Scientific and Practical Center for TB and Pulmonology | Minsk | 220053 | Belarus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28507117 | Derived | Van't Boveneind-Vrubleuskaya N, Seuruk T, van Hateren K, van der Laan T, Kosterink JGW, van der Werf TS, van Soolingen D, van den Hof S, Skrahina A, Alffenaar JC. Pharmacokinetics of Levofloxacin in Multidrug- and Extensively Drug-Resistant Tuberculosis Patients. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00343-17. doi: 10.1128/AAC.00343-17. Print 2017 Aug. | |
| 28507113 |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D018088 | Tuberculosis, Multidrug-Resistant |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D010599 | Pharmacokinetics |
| ID | Term |
|---|---|
| D008660 | Metabolism |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |
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Based on the drug concetrations during the dosing interval and patient characteristics (height, bodyweight, age) the drug clearance will be calculated
| after day 8 of treatment |
| after day 8 of treatment |
| Velasquez AMA, Ribeiro WC, Venn V, Castelli S, Camargo MS, de Assis RP, de Souza RA, Ribeiro AR, Passalacqua TG, da Rosa JA, Baviera AM, Mauro AE, Desideri A, Almeida-Amaral EE, Graminha MAS. Efficacy of a Binuclear Cyclopalladated Compound Therapy for Cutaneous Leishmaniasis in the Murine Model of Infection with Leishmania amazonensis and Its Inhibitory Effect on Topoisomerase 1B. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00688-17. doi: 10.1128/AAC.00688-17. Print 2017 Aug. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |