Safety and Effectiveness of Meropenem in Infants With Suspected or Complicated Intra-abdominal Infections

Cohen‐Wolkowiez, Michael; Poindexter, Brenda B.; Bidegain, Margarita; Weitkamp, Jörn-Hendrik; Schelonka, Robert L.; Randolph, David A.; Ward, Robert M.; Wade, Kelly C.; Valencia, Gloria; Burchfield, David J.; Arrieta, Antonio; Mehta, Varsha; Walsh, Michele C.; Kantak, Anand; Rasmussen, Maynard; Sullivan, Janice E.; Finer, Neil N.; Rich, Wade; Brozanski, Beverly; Anker, John van den; Blumer, Jeffrey L.; Laughon, Matthew M.; Watt, Kevin M.; Kearns, Gregory L.; Capparelli, Edmund V.; Martz, Karen; Berezny, Katherine; Benjamin, Daniel K.; Smith, P. Brian

doi:10.1093/cid/cis758

Cited by 58 publications

(50 citation statements)

References 18 publications

(21 reference statements)

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“…The high therapeutic outcomes reported in this study was constant with a results reported by Cohen et al, which found that the majority of patients treated with meropenem met the therapeutic success [21].…”

Section: Discussionsupporting

confidence: 89%

Evaluation of Meropenem Utilization in Intensive Care Unit in Sudan

Sanhoury¹,

Eldalo²

2016

Int J Clin Pharmacol Pharmacother

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Background: Antimicrobial agents are one of the frequently utilized drug classes in anIntensive Care Unit setting (ICU). Objective: was to evaluate the meropenem utilization among Sudanese patients in the ICU in military hospital. Method: A retrospective study was carried out in the ICU in military hospital during the period from September 2014 to February 2015.A well designed pretested questionnaire was used to collect the data. The collected data was analyzed using SPSS software version 17. Results: A total of 135 patients' files were encountered. The results showed that, no culture was done for any patient before meropenem used. Overall 80% of meropenem was prescribed empirically, Out of the patients who's having meropenem, 7.41% were diagnosed pneumonias and 12.59% septicemia. Creatinine clearance was ranged from 50 to137 ml/min in a total 40.8% of patients used meropenem, so they didn't need dose adjustment, while 59.2 % of them needed dose adjustment since their creatinine clearance was range from 50 to 10 ml/min. The therapeutic response was high 65.2% among the patients who using meropenem, while only 14.8% of them were not cured by this antibiotic. The dose was 0.5-1 gm meropenem twelve hourly for most of patients. Conclusion: Meropenem use in ICU appears to be inconsistent with evidence based assessment criteria. The most evident inappropriateness was observed in empirical therapy. The study also detected other potential problematic areas where concordance with standard guidelines is yet to be achieved. Continuous medical education, functional drug and therapeutic committees and regular drug utilization evaluation programs could help in accomplishing the milestone of rational medication use.

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Section: Discussionsupporting

confidence: 89%

Evaluation of Meropenem Utilization in Intensive Care Unit in Sudan

Sanhoury¹,

Eldalo²

2016

Int J Clin Pharmacol Pharmacother

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“…Conducting an adequately powered prospective safety study of ampicillin and measuring drug plasma levels would not be feasible in infants. An alternative, more focused approach to studying the safety of drugs in infants previously was published for the antibiotic meropenem(25, 26). …”

Section: Discussionmentioning

confidence: 99%

Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates

Hornik

Benjamin

Smith

et al. 2016

The Journal of Pediatrics

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Objective To evaluate the relationship between ampicillin dosing, exposure, and seizures. Study design Retrospective observational cohort study of electronic health record (EHR) data combined with pharmacokinetic model derived drug exposure predictions. EHR from 348 Pediatrix Medical Group neonatal intensive care units from 1997 to 2012. All infants 24–41 weeks gestational age, 500–5400 g birth weight, first exposed to ampicillin prior to 25 days postnatal age. Using a 1-compartment pharmacokinetic model and her data, we simulated maximum ampicillin concentration at steady state (Cmaxss, µg/mL) and area under the concentration time curve from 0 to 24 hours (AUC24, µg*h/dL). Using multivariable logistic regression, we evaluated association between ampicillin dosing, exposure and seizures as documented in the EHR. Results We identified 131,723 infants receiving 134,041 courses of ampicillin for 653,506 infant-days of exposure. The median daily dose was 200 mg/kg/day (25th, 75th percentile; 100, 200). Median Cmaxss and AUC24 were 256.6 µg/mL (164.3, 291.5) and 2593 µg*h/dL (1917, 3334). On multivariable analysis, dosing was not associated with seizures. However increasing Cmaxss [Odds ratio (OR) = 1.10, (95% confidence interval (CI) 1.03, 1.17] and AUC24 [OR = 1.11, (95% CI 1.05, 1.18)] were associated with increased odds of seizures. Conclusions In this cohort of hospitalized infants, higher ampicillin exposure was associated with seizures as documented in the EHR.

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“…No other carbapenems have been approved by the U.S. Food and Drug Administration or European Medicines Agency for neonates or young infants Յ3 months of age, although investigations with meropenem have been conducted in neonates and are ongoing (6)(7)(8)(9). Meropenem is approved for bacterial meningitis or complicated intra-abdominal infections in adults and infants aged Ͼ3 months, and ertapenem is approved for complicated intra-abdominal, urinary tract, and (sub)cutaneous infections, and community-acquired pneumonia in adults and children (Ͼ3 months) (6).…”

mentioning

confidence: 99%

Open-Label Study To Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Doripenem in Infants Less than 12 Weeks in Chronological Age

Cirillo

Vaccaro

Castaneda-Ruiz

et al. 2015

Antimicrob Agents Chemother

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e Doripenem, a parenteral carbapenem with broad-spectrum activity against aerobic Gram-negative and Gram-positive and anaerobic pathogens, is currently approved for use in adults in the United States and European Union. Single-dose doripenem pharmacokinetics in 52 infants <12 weeks in chronological age were investigated in this phase 1 study. Hospitalized, medically stable infants <12 weeks in chronological age were stratified into 6 groups based on chronological and gestational age designed to reflect increasing renal maturation and decreasing volume of distribution (

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Safety and Effectiveness of Meropenem in Infants With Suspected or Complicated Intra-abdominal Infections

Abstract: NCT00621192.

Cited by 58 publications

References 18 publications

Evaluation of Meropenem Utilization in Intensive Care Unit in Sudan

Evaluation of Meropenem Utilization in Intensive Care Unit in Sudan

Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates

Open-Label Study To Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Doripenem in Infants Less than 12 Weeks in Chronological Age

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