Aminoglycoside Plasma Level Measurement in Neonates With Infection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Indonesia University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Rianto Setiabudy, Indonesia University
ClinicalTrials.gov Identifier:
NCT01624324
First received: June 18, 2012
Last updated: July 8, 2012
Last verified: July 2012
  Purpose

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
Nephrotoxicity
Ototoxicity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aminoglycoside Plasma Level Measurement in Neonates With Infection

Further study details as provided by Indonesia University:

Biospecimen Description:

Plasma, Urine


Estimated Enrollment: 25
Study Start Date: November 2010
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.

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624324

Locations
Indonesia
Perinatology Division, Pediatric Department, Cipto Mangunkusumo Hospital Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Adisti Dwijayanti, MD    0817840307    adistimiltiades@gmail.com   
Sub-Investigator: Adisti Dwijayanti, MD         
Sponsors and Collaborators
Indonesia University
  More Information

No publications provided by Indonesia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rianto Setiabudy, Prof. Dr. dr. SpFK(K), Indonesia University
ClinicalTrials.gov Identifier: NCT01624324     History of Changes
Other Study ID Numbers: Aminoglycoside
Study First Received: June 18, 2012
Last Updated: July 8, 2012
Health Authority: Indonesia: The National Agency of Drug and Food Control

Keywords provided by Indonesia University:
aminoglycoside
KIM-1
DPOAE
nephrotoxicity
ototoxicity

ClinicalTrials.gov processed this record on August 01, 2014