NCT01624324

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

First QC Date

June 18, 2012

Last Update Submit

July 8, 2012

Conditions

NephrotoxicityOtotoxicity

Keywords

aminoglycosideKIM-1DPOAEnephrotoxicityototoxicity

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

neonates hospitalized in Perinatology Division, Pediatric Department, Cipto Mangunkusumo Hospital with severe infection requiring an aminoglycoside therapy

You may qualify if:

  • neonates with infection treated with gentamicin or amikacin

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Perinatology Division, Pediatric Department, Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23557866DERIVED

Biospecimen

Plasma, Urine

MeSH Terms

Conditions

Ototoxicity

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. dr. SpFK(K)

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 20, 2012

Study Start

November 1, 2010

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

ID(1)