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

Pharmacokinetic evaluation and local tolerability of dry powder amikacin via the Cyclops® in patients with drug susceptible tuberculosis - Amika-01

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55683

Enrollment

Registered

2019-10-04

Start date

2020-05-27

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

Netherlands

Outcome results