Pharmacokinetics of Levofloxacin and Capreomycin in Multidrug-Resistant Tuberculosis Patients

NCT ID: NCT02169141

Last Updated: 2014-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-11-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Tuberculosis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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

Pharmacokinetics

Intervention Type OTHER

multiple blood samples are obtained by means of an indwelling intravenous catheter for calculating PK parameters

Interventions

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Pharmacokinetics

multiple blood samples are obtained by means of an indwelling intravenous catheter for calculating PK parameters

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age\> 18yrs
* culture positive
* diagnosis of MDR-TB

Exclusion Criteria

* DM2
* Pregnancy
* allergy to IV canula material
* insertion of IV canula not possibele
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Republican Scientific and Practical Centre for Pulmonology and TB

UNKNOWN

Sponsor Role collaborator

National Institute for Public Health and the Environment (RIVM)

OTHER_GOV

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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JWC Alffenaar

PhD PharmD Clinical Pharmacologist Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JW C Alffenaar, PhD PharmD

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

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Republican Scientific and Practical Center for TB and Pulmonology

Minsk, , Belarus

Site Status

Countries

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Belarus

References

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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.

Reference Type DERIVED
PMID: 28507117 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28507113 (View on PubMed)

Other Identifiers

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LC-20

Identifier Type: -

Identifier Source: org_study_id

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