Studying the effect of montelukast on amikacin nephrotoxicity in children

Evaluation of the protective effects of montelukast in the prevention of amikacin-induced renal injury in children with urinary tract infection: a randomized, double-blind clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250202064597N1

Enrollment

Registered

2025-09-03

Start date

2026-03-21

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Drug-induced kidney damage. Urinary tract infection, site not specified

Interventions

Intervention 1: Intervention group: Montelukast 5 mg chewable tablet daily (4 mg in children under 6 years of age) plus amikacin 15 mg/kg ampoule daily in three divided doses. Intervention 2: Control

Eligibility

Sex/Gender

All

Age

6 Months to 15 Years

Inclusion criteria

Inclusion criteria: All children aged 6 months to 15 years who have been diagnosed with a urinary tract infection by a pediatric specialist and are scheduled to be treated with amikacin

Exclusion criteria

Exclusion criteria: 1- All sick children whose parents did not agree to cooperate 2- Patients with kidney anomalies 3- Patients with kidney stones 4- Cases of positive urine culture with several types of microbes 5- Cases of positive culture that is resistant to the drug 6- Allergy to the drug montelukast

Design outcomes

Primary

Measure	Time frame
Cystatin C. Timepoint: Day zero before receiving the first dose of amikacin and the last day of treatment. Method of measurement: Laboratory kit and autoanalyzer.;Serum creatinine. Timepoint: Once on day zero before receiving the first dose of amikacin and then every other day until the last day of treatment. Method of measurement: Laboratory kit and autoanalyzer.;Blood urea nitrogen. Timepoint: Once on day zero before receiving the first dose of amikacin and then every other day until the last day of treatment. Method of measurement: Laboratory kit.;Serum malondialdehyde level (MDA). Timepoint: Day zero before receiving the first dose of amikacin and the last day of treatment. Method of measurement: Laboratory kit.;Glutathione level (GSH). Timepoint: Day zero before receiving the first dose of amikacin and the last day of treatment. Method of measurement: Laboratory kit.;Tissue necrosis factor (TNF-a). Timepoint: Day zero before receiving the first dose of amikacin and the last day of treatment. Method of measurement: Laboratory kit.	—

Measure

Time frame

Cystatin C. Timepoint: Day zero before receiving the first dose of amikacin and the last day of treatment. Method of measurement: Laboratory kit and autoanalyzer.;Serum creatinine. Timepoint: Once on day zero before receiving the first dose of amikacin and then every other day until the last day of treatment. Method of measurement: Laboratory kit and autoanalyzer.;Blood urea nitrogen. Timepoint: Once on day zero before receiving the first dose of amikacin and then every other day until the last day of treatment. Method of measurement: Laboratory kit.;Serum malondialdehyde level (MDA). Timepoint: Day zero before receiving the first dose of amikacin and the last day of treatment. Method of measurement: Laboratory kit.;Glutathione level (GSH). Timepoint: Day zero before receiving the first dose of amikacin and the last day of treatment. Method of measurement: Laboratory kit.;Tissue necrosis factor (TNF-a). Timepoint: Day zero before receiving the first dose of amikacin and the last day of treatment. Method of measurement: Laboratory kit.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Nazari Taloki

Babol University of Medical Sciences

zahra_nazari_taloki@yahoo.com+98 11 3219 9592

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026