Aminoglycoside Plasma Level Measurement in Neonates With Infection

• Conditions: Nephrotoxicity; Ototoxicity

• Registration Number: NCT01624324
• Lead Sponsor: Indonesia University

Brief Summary

The aim of this study is to determine whether the plasma concentration of aminoglycoside in Indonesia neonates with infection are within safe and effective range and its association with cochlear toxicity and nephrotoxicity.

Detailed Description

Aminoglycosides are toxic antibiotics, but they are urgently needed to treat newborns with severe infections. Aminoglycosides are well known for their nephrotoxicity and ototoxicity, meanwhile the renal function of the newborns is not yet fully developed.The aminoglycoside dosage currently applied in Indonesia is derived from studies done in Caucasian populations. The safety and efficacy of this dosage regimen, however, have never been evaluated till date. The pharmacokinetic profile of drugs may vary between populations and this may be influenced by genetic factors, lifestyle, drug interactions, etc. The detection of aminoglycoside toxicity in newborns is usually problematic. The present study aims to know the proportion of nephrotoxicity and ototoxicity in newborns in the Cipto Mangunkusumo Hospital treated with gentamicin or amikacin in relation to their trough serum concentration. The serum level of gentamicin and amikacin is assumed to be safe if the trough serum concentrations are \< 2 mcg/mL and effective if its is between 5-12 mcg/mL. For amikacin the desired trough serum concentrations are \<10 mcg/mL and the peak is between 20-30 mcg/mL. The nephrotoxicity was assessed by measuring the level of kidney injury molecule-1 in urine while the ototoxicity was assessed by Distortion Product Otoacoustic Emission (DPOE) instrument.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-20
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-08
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• neonates with infection treated with gentamicin or amikacin

Exclusion Criteria

• neonates who hypersensitive to gentamicin and amikacin
• neonates who also treated with other nephrotoxic drugs (vancomycin, furosemide, amphotericin B, meropenem)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Perinatology Division, Pediatric Department, Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia