Aminoglycoside Plasma Level Measurement in Neonates With Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01624324
Recruitment Status : Unknown
Verified July 2012 by Rianto Setiabudy, Indonesia University.
Recruitment status was:  Recruiting
First Posted : June 20, 2012
Last Update Posted : July 10, 2012
Information provided by (Responsible Party):
Rianto Setiabudy, 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.

Condition or disease
Nephrotoxicity Ototoxicity

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 Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aminoglycoside Plasma Level Measurement in Neonates With Infection
Study Start Date : November 2010

Biospecimen Description:
Plasma, Urine

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
neonates hospitalized in Perinatology Division, Pediatric Department, Cipto Mangunkusumo Hospital with severe infection requiring an aminoglycoside therapy

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01624324

Perinatology Division, Pediatric Department, Cipto Mangunkusumo Hospital Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Adisti Dwijayanti, MD    0817840307   
Sub-Investigator: Adisti Dwijayanti, MD         
Sponsors and Collaborators
Indonesia University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rianto Setiabudy, Prof. Dr. dr. SpFK(K), Indonesia University Identifier: NCT01624324     History of Changes
Other Study ID Numbers: Aminoglycoside
First Posted: June 20, 2012    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Rianto Setiabudy, Indonesia University: