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NCT01624324 Clinical Trial

Aminoglycoside Plasma Level Measurement in Neonates With Infection

Ototoxicity Clinical Trial

Official title:
Aminoglycoside Plasma Level Measurement in Neonates With Infection

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01624324
Other study ID # Aminoglycoside
Secondary ID
Status Recruiting
Phase N/A
First received June 18, 2012
Last updated July 8, 2012
Start date November 2010

Study information
Verified date July 2012
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority Indonesia: The National Agency of Drug and Food Control
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Month
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Indonesia Perinatology Division, Pediatric Department, Cipto Mangunkusumo Hospital Jakarta Pusat DKI Jakarta

Sponsors (1)
Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

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