Pharmacokinetic evaluation and local tolerability of dry powder amikacin via the Cyclops® in patients with drug susceptible tuberculosis

Completed

• Conditions: Tuberculosis; 10028440

• Registration Number: NL-OMON55683
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

* Age above 18 years
* Diagnosed with DSTB, either by culture or molecular testing
* Obtained written informed consent

Exclusion Criteria

* Pregnancy or breast feeding
* Subjects with known or suspected (by spontaneous reporting or by active
questioning) renal, auditory, vestibular or neuromuscular dysfunction.
* History of adverse events on previous amikacin or other aminoglycoside use
(by spontaneous reporting nor by active questioning)
* Concurrent use of aminoglycosides, cyclosporin, cisplatin, amfotericin B,
cephalosporins, polymyxins and vancomycin

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The following pharmacokinetic parameters will be calculated: actual dose (dose<br /><br>minus remainder in inhaler after inhalation), AUC0-24 (area under the curve<br /><br>from 0-24 h), Cmax (maximum serum concentration), Tmax (time to maximum serum<br /><br>concentration).<br /><br><br /><br>For local tolerability of the inhalation of dry powder amikacin the following<br /><br>procedures will be done. Both points need to have a positive result.<br /><br>* Drop of FEV1 of >15 % (lung function measurement)<br /><br>* Questioning/ registration adverse events </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Inspiratory parameters during the inhalation maneuver. Following parameters<br /><br>will be calculated:<br /><br>* dPmax (maximum pressure drop)<br /><br>* Vi (inhaled volume)<br /><br>* Ti (total inhalation time)<br /><br>* PIF (peak inspiratory flow rate)<br /><br>* MIF (mean inspiratory flow rate)<br /><br>* FIR (average flow increase rate between 20% and 80% of PIF)</p><br>