A prospective, double-blind, randomized study comparing the efficacy and safety of low-dose ciprofloxacin with ampicillin in the treatment of bronchitis

Chmel, Herman; Emmanuel, George; Lie, T.; Anderson, Lynn L.; Ireland, J. C.

doi:10.1016/0732-8893(90)90098-g

Diagnostic Microbiology and Infectious Disease

1990

DOI: 10.1016/0732-8893(90)90098-g

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A prospective, double-blind, randomized study comparing the efficacy and safety of low-dose ciprofloxacin with ampicillin in the treatment of bronchitis

Herman Chmel

George Emmanuel

T. Lie

et al.

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Cited by 7 publications

(1 citation statement)

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“…The PK of ampicillin have been studied in children and adults (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14), but data on dosing in the neonatal population are sparse. Current dosing regimens take into account the gestational age (GA)-and postmenstrual age (PMA)-related variation in renal drug clearance and recommend lower doses and less frequent dosing in the most premature neonates (1).…”

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confidence: 99%

Characterization of the Population Pharmacokinetics of Ampicillin in Neonates Using an Opportunistic Study Design

Tremoulet

Lê

Poindexter

et al. 2014

Antimicrob Agents Chemother

107

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iAlthough ampicillin is the most commonly used drug in neonates, developmental pharmacokinetic (PK) data to guide dosing are lacking. Ampicillin is primarily renally eliminated, and developmental changes are expected to influence PK. We conducted an open-label, multicenter, opportunistic, prospective PK study of ampicillin in neonates stratified by gestational age (GA) (<34 or >34 weeks) and postnatal age (PNA) (<7 or >7 days). Drug concentrations were measured by tandem mass spectrometry. PK data were analyzed using population nonlinear mixed-effects modeling in NONMEM 7.2. Monte Carlo simulations were conducted to determine the probability of target attainment for the time in which the total steady-state ampicillin concentrations remained above the MIC (T>MIC) for 50%, 75%, and 100% of the dosing interval. A total of 142 PK samples from 73 neonates were analyzed (median [range] GA, 36 [24 to 41] weeks; PNA, 5 [0 to 25] days). The median ampicillin dose was 200 (100 to 350) mg/kg/day. Postmenstrual age and serum creatinine were covariates for ampicillin clearance (CL). A simplified dosing regimen of 50 mg/kg every 12 h for GA of <34 weeks and PNA of <7 days, 75 mg/kg every 12 h for GA of <34 weeks and PNA of >8 and <28 days, and 50 mg/kg every 8 h for GA of >34 weeks and PNA of <28 days achieved the prespecified surrogate efficacy target in 90% of simulated subjects. Ampicillin CL was associated with neonatal development. A simplified dosing regimen stratified by GA and PNA achieves the desired surrogate therapeutic target in the vast majority of neonates.

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mentioning

confidence: 99%

Characterization of the Population Pharmacokinetics of Ampicillin in Neonates Using an Opportunistic Study Design

Tremoulet

Lê

Poindexter

et al. 2014

Antimicrob Agents Chemother

107

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Use of quinolones for the treatment of acute exacerbations of chronic bronchitis

Chodosh

1991

The American Journal of Medicine

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Overview of fluoroquinolone safety

Wolfson¹,

Hooper

1991

The American Journal of Medicine

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A prospective, double-blind, randomized study comparing the efficacy and safety of low-dose ciprofloxacin with ampicillin in the treatment of bronchitis

Cited by 7 publications

References 5 publications

Characterization of the Population Pharmacokinetics of Ampicillin in Neonates Using an Opportunistic Study Design

Characterization of the Population Pharmacokinetics of Ampicillin in Neonates Using an Opportunistic Study Design

Use of quinolones for the treatment of acute exacerbations of chronic bronchitis

Overview of fluoroquinolone safety

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