NCT02169141

Brief Summary

This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

3 months

First QC Date

June 12, 2014

Last Update Submit

June 20, 2014

Conditions

Tuberculosis

Keywords

pharmacokineticspharmacodynamicsMDR-TBLevofloxacinCapreomycin

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • Volume of Distribution

    after day 8 of treatment

  • Clearance

    after day 8 of treatment

Other Outcomes (2)

  • PK-model

    after day 8 of treatment

  • Limited sampling strategy

    after day 8 of treatment

Study Arms (1)

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

Other: Pharmacokinetics

Interventions

PharmacokineticsOTHER

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

PK of Levofloxacin-Capreomycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MDR-TB patients

You may qualify if:

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

You may not qualify if:

  • DM2
  • Pregnancy
  • allergy to IV canula material
  • insertion of IV canula not possibele

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Republican Scientific and Practical Center for TB and Pulmonology

Minsk, 220053, Belarus

Location

Related Publications (2)

  • 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.

    PMID: 28507117DERIVED

  • 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.

    PMID: 28507113DERIVED

MeSH Terms

Conditions

TuberculosisTuberculosis, Multidrug-Resistant

Interventions

Pharmacokinetics

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

MetabolismPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Officials

  • JW C Alffenaar, PhD PharmD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD PharmD Clinical Pharmacologist Associate Professor

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 23, 2014

Study Start

November 1, 2012

Primary Completion

February 1, 2013

Study Completion

November 1, 2013

Last Updated

June 23, 2014

Record last verified: 2014-06

Locations

BE(1)