comparison between intravenous aminoglycosides versus nebulize aminoglycosides in cystic fibrosis patients

Clinical trial of comparison between use of intravenous aminoglycosides versus intravenous and nebulize aminoglycosides in cystic fibrosis patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120415009475N10

Enrollment

Registered

2021-06-19

Start date

2021-05-05

Completion date

Unknown

Last updated

2021-06-21

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

Conditions

cystic fibrosis. Cystic fibrosis

Interventions

Intervention 1: Intervention group: Ceftazidime 50 milligrams per kg three times a day as intravenous, Amikacin 20 milligrams per kg one time a day as intravenous and Amikacin 500 milligrams as nebuli

Eligibility

Sex/Gender

All

Age

6 Years to 18 Years

Inclusion criteria

Inclusion criteria: cystic fibrosis flare up

Exclusion criteria

Exclusion criteria: chronic kidney disease hepatic failure metabolic disorder myopathy hearing loss neuromuscular disease electrolyte disturbances

Design outcomes

Primary

Measure	Time frame
Forced expiratory volume in the first second (FEV1). Timepoint: in baseline and 14 days after beginning of treatment. Method of measurement: Spirometer.	—

Secondary

Measure	Time frame
Amikacin blood concentration. Timepoint: Before the 4th dose. Method of measurement: Amikacin ELISA Kit.;Hearing loss. Timepoint: In baseline and 14 days after beginning of treatment. Method of measurement: Auditory Brainstem Response (ABR) testing.;Serum cratinine. Timepoint: Every 48 hours. Method of measurement: Jaffe's Kinetic Method.;Hospital stay. Timepoint: Day. Method of measurement: Counting.	—

Measure

Time frame

Amikacin blood concentration. Timepoint: Before the 4th dose. Method of measurement: Amikacin ELISA Kit.;Hearing loss. Timepoint: In baseline and 14 days after beginning of treatment. Method of measurement: Auditory Brainstem Response (ABR) testing.;Serum cratinine. Timepoint: Every 48 hours. Method of measurement: Jaffe's Kinetic Method.;Hospital stay. Timepoint: Day. Method of measurement: Counting.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmin Rakhshan

Shahid Beheshti University of Medical Sciences

aminrakhshan@gmail.com+98 21 8820 0119

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 9, 2026