Efficacy and safety of a single daily dose of gentamicin in hospitalized Indian children: a quasi-randomized trial

Tiwari, Soumya; Rehan, Harmeet Singh; Chandra, Jagdish; Mathur, N. N.; Singh, Varinder

doi:10.1093/jac/dkp330

Cited by 11 publications

(8 citation statements)

References 18 publications

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“…Once-daily dosing of gentamycin was safe and efficacious with a more favorable clinical response (89% versus 76%) and more favorable peak concentrations (100% in once-daily dosing versus 87% in multiple-daily dosing). Moreover, undesirable range of trough concentrations was 0% and 17% in once-daily dosing and multiple daily dosing, respectively (25). Similar results were reported in febrile neutropenic children who received stem cell transplantation.…”

Section: Review Of Trialssupporting

confidence: 83%

Extended-Interval Dosing of Aminoglycosides in Pediatrics: A Narrative Review

Salehifar¹,

Rafati

2015

J Pediatr Rev

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Aminoglycosides (AGs) are frequently used in pediatric settings, especially for empiric treatment of early-onset neonatal sepsis. Although AGs are used for several decades, the optimum method of administration and their dosing schemes needs more clarification. The risks of ototoxicity and nephrotoxicity, two main toxicities associated with AGs, have been contributed to the peak and trough plasma levels, respectively. One approach to decrease these potential toxicities of AGs is to administer higher doses with a prolonged interval, named extended-interval dosing (EID). Post-antibiotic effect (PAE) and concentration-dependent killing of AGs provide rational basis for the efficacy of EID. PAE refers to the extended bactericidal activity of AGs against many Gram-negative organisms after the drug was removed by metabolism. One concern is that the higher initial peak concentration with EID may be accompanied with more toxicities, especially ototoxicity. It was demonstrated that due to saturation of binding site of AGs in renal and cochlear tissues, transiently higher concentration of AGs does not cause additional nephrotoxicity or ototoxicity. Experience and clinical evidence regarding EID in pediatrics is suboptimal. In this review, we presented the rational and studies focusing on EID in pediatric setting. The overall finding of trials is that in pediatric setting, EID is a safe and effective dosing method. The risk of serum drug concentration outside the therapeutic range is lower in neonates treated with EID, leading to less need of therapeutic drug monitoring (TDM) with EID. Moreover, there are evidences supporting lower chance of bacterial resistance with EID compared with traditional dosing approach.

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Section: Review Of Trialssupporting

confidence: 83%

Extended-Interval Dosing of Aminoglycosides in Pediatrics: A Narrative Review

Salehifar¹,

Rafati

2015

J Pediatr Rev

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“…Therefore, amikacin can be considered to be the aminoglycoside active against gentamicinresistant (GM-R) Enterobacteriaceae. 4,26 Though it has been recognized by clinicians that aminoglycosides such as gentamicin or amikacin are effective in the treatment of APN, 22,25,27 a few clinical studies have been focusing on the use of gentamicin as initial empiric antibiotic therapy of APN patients during the last 10 years. It is important to understand the therapeutic efficacy and safety of gentamicin in the treatment of APN, considering its low cost, its postantibiotic effect, and its concentration-dependent bactericidal action.…”

Section: Introductionmentioning

confidence: 99%

Use of Gentamicin for Women with Community-Acquired Uncomplicated Acute Pyelonephritis Caused by Gentamicin-Susceptible or -ResistantEscherichia coli:10-Year Experience

Wie

Kim

Chang

2013

Microbial Drug Resistance

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The objectives of this study were to evaluate the clinical effectiveness of gentamicin as an initial empirical antimicrobial agent and to determine the effects of gentamicin resistance on clinical outcomes in women with uncomplicated acute pyelonephritis (APN). We analyzed data of 2,033 women with a diagnosis of APN admitted to Catholic University St. Vincent's Hospital. Of those, we enrolled 274 cases of community-acquired uncomplicated APN due to Escherichia coli who received gentamicin as initial antibiotics. Of these 274 patients, 47 patients had gentamicin-resistant (GM-R) E. coli APN, and 227 patients had gentamicin-susceptible (GM-S) E. coli APN. The early clinical response rates were 55.3% (26/47) versus 81.5% (185/227) at 72 hours; 61.7% (29/47) versus 96.9% (220/227) at 96 hours in the GM-R and GM-S groups, which was significantly higher in the GM-S group (p<0.001). Overall clinical cure rates were 100% (47/47) and 99.6% (226/227) in the GM-R and GM-S groups, respectively. APN patients in the GM-R group had longer hospitalization (9.72 ± 3.46 and 7.89 ± 2.27 days; p<0.001) than those in the GM-S group. Resistance of E. coli to gentamicin, bacteremia, and C-reactive protein level showed independent effects on early clinical failure. Aminoglycoside such as gentamicin can be an alternative antibiotic option for initial empirical therapy of community-acquired uncomplicated APN as the fluoroquinolone-sparing or broad-spectrum cephalosporin-sparing agents in an era of increasing antimicrobial resistance, especially in areas where medical resources are limited or antibiotic resistance rate of the uropathogens is high.

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“…Use of high-dose, extended-interval aminoglycoside therapy was commonly reported for disease states beyond cystic fibrosis, urinary tract infection, and febrile neutropenia, including pneumonia, meningitis, and (in some institutions) all infections in which suspected pathogens might be susceptible. There is evidence demonstrating the efficacy and safety of this approach in these additional disease states as mentioned by respondents, 19,[25][26][27][28] although the evidence for its use in pediatric patients is more established for the disease states that were specifically questioned.…”

Section: Discussionmentioning

confidence: 99%

High-Dose, Extended-Interval Gentamicin and Tobramycin for Pediatric Inpatients: A Survey of Canadian Hospital Pharmacists

Roy

Gray

Ruda

et al. 2016

CJHP

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ABSTRACTBackground: The use of high-dose, extended-interval aminoglycosides, a common practice in adult populations, is less well established for pediatric patients. In younger populations, these drugs are often administered according to a multiple daily dosing method.Objective: To characterize prescribing practices for aminoglycosides in pediatric inpatients across Canada, with a focus on high-dose, extended interval regimens.Methods: This study was based on an electronic survey of pharmacists representing Canadian health care delivery organizations that provided pediatric inpatient services, which was distributed in March 2015. Questions focused on demographic characteristics; indications for highdose, extended-interval tobramycin or gentamicin; use of these regimens in patients with particular comorbidities; empiric dosing; monitoring parameters; and the extent of pharmacists’ authority to independently prescribe doses and order monitoring parameters for aminoglycosides at their respective institutions.Results: Forty-five (48%) of the 94 prospective participants responded to the survey. Of these 45 respondents, 35 (78%) indicated that their respective health regions used high-dose, extended-interval tobramycin or gentamicin in pediatric inpatients. The patient characteristics for use of such regimens were varied. The median reported doses were 10 mg/kgfor pulmonary exacerbation in cystic fibrosis, 7 mg/kg for urinary tract infection, and 8 mg/kg for febrile neutropenia. Thirty-one (89%) of the 35 respondents using these regimens reported that they monitored serum levels, and 27 (77%) reported monitoring for nephrotoxicity. With regard to prescriptive authority, 7 (16%) of the 45 respondents indicated that pharmacists were authorized to independently adjust dosing at their institutions, and pharmacists at 14 (31%) of 45 sites were authorized to order monitoring parameters.Conclusions: High-dose, extended-interval aminoglycoside therapy was frequently used for pediatric patients across Canada, although the dosages and monitoring practices varied greatly. The information from this study can be used for cross-comparison of practice by other centres across Canada.RÉSUMÉContexte : L’utilisation de doses élevées d’aminosides administrées à intervalle prolongé est une pratique répandue chez l’adulte, mais moins bien établie chez l’enfant. Dans les populations plus jeunes, ces médicaments sont souvent donnés selon une méthode d’administration multiquotidienne.Objectif : Offrir un portrait des habitudes de prescription d’aminosides chez des enfants hospitalisés à l’échelle du Canada en accordant une attention aux schémas posologiques avec administration d’une dose élevée à intervalle prolongé.Méthodes : La présente étude s’appuie sur une enquête électronique réalisée en mars 2015 auprès de pharmaciens représentant des organisms canadiens de prestation de soins de santé qui offrent des services d’hospitalisation pour les enfants. Les questions portaient sur : les caractéristiques démographiques; les indications pour les doses élevées à intervalle posologique prolongé de gentamicine ou de tobramycine; l’emploi de ces schémas chez les patients atteints de certaines comorbidités; les posologies empiriques; les paramètres de surveillance; et l’étendue du droit que détiennent les pharmaciens de prescrire les doses d’aminosides de façon indépendante et les paramètres de surveillance connexes dans leurs établissements respectifs.Résultats : Quarante-cinq (48 %) des 94 potentiels participants ont répondu au sondage. Parmi les 45 répondants, 35 (78 %) ont indiqué que leur régie régionale de la santé faisait l’emploi de schémas avec administration d’une dose élevée à intervalle prolongé de tobramycine ou de gentamicine chez des enfants hospitalisés. Les caractéristiques des patients pour l’utilisation de tels schémas variaient. Les doses medians signalées étaient de 10 mg/kg pour les exacerbations pulmonaires liées à une fibrose kystique, de 7 mg/kg pour les infections urinaires et de 8 mg/kg pour les neutropénies fébriles. Trente et un (89 %) des 35 répondants utilisant ces schémas ont indiqué qu’ils surveillaient les taux sériques et 27 (77 %) ont signalé exercer un suivi pour déceler une néphrotoxicité. En ce qui touche au droit de prescrire, 7 (16 %) des 45 répondants ont indiqué que les pharmaciens étaient autorisés à modifier eux-mêmes la posologie dans leurs établissements et des pharmaciens dans 14 (31 %) des 45 établissements étaient autorisés à prescrire des paramètres de surveillance.Conclusions : Les traitements par aminosides avec administration d’une dose élevée à intervalle prolongé étaient fréquemment utilisés pour les enfants partout au Canada, mais les posologies et les habitudes de surveillance variaient beaucoup. L’information contenue dans la présente étude peut servir à faire la comparaison des habitudes au sein d’autres centres à l’échelle du Canada.

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Efficacy and safety of a single daily dose of gentamicin in hospitalized Indian children: a quasi-randomized trial

Abstract: The study supports extended-interval (single daily) dosing in hospitalized Indian children due to its efficacy and safety with the added advantage of needing fewer injections.

Cited by 11 publications

References 18 publications

Extended-Interval Dosing of Aminoglycosides in Pediatrics: A Narrative Review

Extended-Interval Dosing of Aminoglycosides in Pediatrics: A Narrative Review

Use of Gentamicin for Women with Community-Acquired Uncomplicated Acute Pyelonephritis Caused by Gentamicin-Susceptible or -ResistantEscherichia coli:10-Year Experience

High-Dose, Extended-Interval Gentamicin and Tobramycin for Pediatric Inpatients: A Survey of Canadian Hospital Pharmacists

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