Clinical trial NCT01624324: Aminoglycoside Plasma Level Measurement in Neonates With Infection
Official title: Aminoglycoside Plasma Level Measurement in Neonates With Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nephrotoxicity
Ototoxicity
Keywords: aminoglycoside
KIM-1
DPOAE
nephrotoxicity
ototoxicity
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 25
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: neonates hospitalized in Perinatology Division, Pediatric Department, Cipto Mangunkusumo Hospital with severe infection requiring an aminoglycoside therapy

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.

Eligibility 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Perinatology Division, Pediatric Department, Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
References:
citation: Setiabudy R, Suwento R, Rundjan L, Yasin FH, Louisa M, Dwijayanti A, Simanjuntak E. Lack of a relationship between the serum concentration of aminoglycosides and ototoxicity in neonates. Int J Clin Pharmacol Ther. 2013 May;51(5):401-6. doi: 10.5414/CP201833.