Treatment of complicated urinary tract infection in adults: Combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy

Wilbur G. Wells; Gail L. Woods; Qi Jiang; Richard M. Gesser; Elizabeth A. Albertson; Mohamed S. Al-Ibrahim; Emmanuel A. Burdman; Thomas F. Burke; Stacy Childs; Clair Cox; Robert H.K. Eng; Elliot Frank; Robert Brooks Gainer; Fernando Gonzalez Fuenzalida; John A. Gezon; Theodore Herman; Karny Jacoby; Andrew H. Krinsky; Richard E. Landau; William Moseley; M. Sigfrido Rangel-Frausto; Gilbert Recinos-Mijangos; John F. Reinchardt; Oscar G. Pamo Reyna; Stuart Sarshik; Albretch Schilling; Kevin M. Tomera; Yair Walzer; John Tuttle; Glen Wells; Alfredo Amenabar; Ian Baird; J. Eric Bauwens; Gary Bergen; Paul Brownstone; Jaime Cajigas; Daniel Coto; Joshua Fierer; Nicolas Flores; Juan Gallego-Gomez; Lionel Gatien; David Gilbert; Abel Jasovich; Fernando Jimenez-Cruz; Danny Keiller; Nancy Khardori; Karl Kreder; Jose Mansa-Pueyo; Michael Marberger; Simon Mirelman; Daniel Pryluka; Michael Rauchenwald; Lybon T. Rikhotso; Miguel Tallada-Bunnuel; Williams Weems; John Wegenke

doi:10.1093/jac/dkh208

Treatment of complicated urinary tract infection in adults: Combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy

Wilbur G. Wells
, Gail L. Woods
, Qi Jiang
, Richard M. Gesser
, Elizabeth A. Albertson
, Mohamed S. Al-Ibrahim
, Emmanuel A. Burdman
, Thomas F. Burke
, Stacy Childs
, Clair Cox
, Robert H.K. Eng
, Elliot Frank
, Robert Brooks Gainer
, Fernando Gonzalez Fuenzalida
, John A. Gezon
, Theodore Herman
, Karny Jacoby
, Andrew H. Krinsky
, Richard E. Landau
, William Moseley

M. Sigfrido Rangel-Frausto, Gilbert Recinos-Mijangos, John F. Reinchardt, Oscar G. Pamo Reyna, Stuart Sarshik, Albretch Schilling, Kevin M. Tomera, Yair Walzer, John Tuttle, Glen Wells, Alfredo Amenabar, Ian Baird, J. Eric Bauwens, Gary Bergen, Paul Brownstone, Jaime Cajigas, Daniel Coto, Joshua Fierer, Nicolas Flores, Juan Gallego-Gomez, Lionel Gatien, David Gilbert, Abel Jasovich, Fernando Jimenez-Cruz, Danny Keiller, Nancy Khardori, Karl Kreder, Jose Mansa-Pueyo, Michael Marberger, Simon Mirelman, Daniel Pryluka, Michael Rauchenwald, Lybon T. Rikhotso, Miguel Tallada-Bunnuel, Williams Weems, John Wegenke

School of Medicine

Hackensack Meridian School of Medicine

Research output: Contribution to journal › Article › peer-review

Abstract

The efficacy and safety of parenteral ertapenem, a Group 1 carbapenem, 1 g once a day, for the treatment of complicated urinary tract infections (UTIs; i.e. acute pyelonephritis, UTI in men, or UTI associated with obstruction, foreign body or a urological abnormality interfering with normal voiding) in adults, were compared with those of parenteral ceftriaxone, 1 g once a day, in two similarly designed prospective, double-blind, randomized studies. In both studies, patients could be switched to an oral agent after ≥3 days of parenteral study therapy. At entry, 850 patients were stratified according to whether they had acute pyelonephritis or other complicated UTI without acute pyelonephritis. Two hundred and fifty-six patients in the ertapenem group and 224 in the ceftriaxone group were microbiologically evaluable. Ninety-six per cent of these patients were switched to oral therapy, usually ciprofloxacin; the median (range) duration of parenteral and total therapy, respectively, was 4 (2-14) days and 13 (14-18) days for ertapenem and 4 (2-14) days and 13 (3-17) days for ceftriaxone. The most common pathogens were Escherichia coli and Klebsiella pneumoniae, which accounted for 64.7% and 9.8% of isolates, respectively. At the primary efficacy endpoint 5-9 days after treatment, 229 (89.5%) patients who received ertapenem and 204 (91.1%) patients who received ceftriaxone had a favourable microbiological response (95% confidence interval, -7.4 to 4.0), indicating that outcomes in the two treatment groups were equivalent. Success rates in both treatment groups were similar when compared by stratum and severity of infection. The frequency and severity of drug-related adverse events were generally similar in both treatment groups. In this combined analysis, ertapenem was highly effective therapy for the treatment of complicated UTIs in adults with moderate-to-severe disease. JAC

Original language	English
Pages (from-to)	ii67-ii74
Journal	Journal of Antimicrobial Chemotherapy
Volume	53
Issue number	SUPPL. 2
DOIs	https://doi.org/10.1093/jac/dkh208
State	Published - Jun 2004

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

ASJC Scopus subject areas

Pharmacology
Microbiology (medical)
Pharmacology (medical)
Infectious Diseases

Keywords

Acute pyelonephritis
Antimicrobial agents
Carbapenems
Efficacy
Safety

Access to Document

10.1093/jac/dkh208

Cite this

Wells, W. G., Woods, G. L., Jiang, Q., Gesser, R. M., Albertson, E. A., Al-Ibrahim, M. S., Burdman, E. A., Burke, T. F., Childs, S., Cox, C., Eng, R. H. K., Frank, E., Brooks Gainer, R., Gonzalez Fuenzalida, F., Gezon, J. A., Herman, T., Jacoby, K., Krinsky, A. H., Landau, R. E., ... Wegenke, J. (2004). Treatment of complicated urinary tract infection in adults: Combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy. Journal of Antimicrobial Chemotherapy, 53(SUPPL. 2), ii67-ii74. https://doi.org/10.1093/jac/dkh208

@article{1236e044b22741149ef24be3fe8a7084,

title = "Treatment of complicated urinary tract infection in adults: Combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy",

abstract = "The efficacy and safety of parenteral ertapenem, a Group 1 carbapenem, 1 g once a day, for the treatment of complicated urinary tract infections (UTIs; i.e. acute pyelonephritis, UTI in men, or UTI associated with obstruction, foreign body or a urological abnormality interfering with normal voiding) in adults, were compared with those of parenteral ceftriaxone, 1 g once a day, in two similarly designed prospective, double-blind, randomized studies. In both studies, patients could be switched to an oral agent after ≥3 days of parenteral study therapy. At entry, 850 patients were stratified according to whether they had acute pyelonephritis or other complicated UTI without acute pyelonephritis. Two hundred and fifty-six patients in the ertapenem group and 224 in the ceftriaxone group were microbiologically evaluable. Ninety-six per cent of these patients were switched to oral therapy, usually ciprofloxacin; the median (range) duration of parenteral and total therapy, respectively, was 4 (2-14) days and 13 (14-18) days for ertapenem and 4 (2-14) days and 13 (3-17) days for ceftriaxone. The most common pathogens were Escherichia coli and Klebsiella pneumoniae, which accounted for 64.7\% and 9.8\% of isolates, respectively. At the primary efficacy endpoint 5-9 days after treatment, 229 (89.5\%) patients who received ertapenem and 204 (91.1\%) patients who received ceftriaxone had a favourable microbiological response (95\% confidence interval, -7.4 to 4.0), indicating that outcomes in the two treatment groups were equivalent. Success rates in both treatment groups were similar when compared by stratum and severity of infection. The frequency and severity of drug-related adverse events were generally similar in both treatment groups. In this combined analysis, ertapenem was highly effective therapy for the treatment of complicated UTIs in adults with moderate-to-severe disease. JAC",

keywords = "Acute pyelonephritis, Antimicrobial agents, Carbapenems, Efficacy, Safety",

author = "Wells, \{Wilbur G.\} and Woods, \{Gail L.\} and Qi Jiang and Gesser, \{Richard M.\} and Albertson, \{Elizabeth A.\} and Al-Ibrahim, \{Mohamed S.\} and Burdman, \{Emmanuel A.\} and Burke, \{Thomas F.\} and Stacy Childs and Clair Cox and Eng, \{Robert H.K.\} and Elliot Frank and \{Brooks Gainer\}, Robert and \{Gonzalez Fuenzalida\}, Fernando and Gezon, \{John A.\} and Theodore Herman and Karny Jacoby and Krinsky, \{Andrew H.\} and Landau, \{Richard E.\} and William Moseley and Rangel-Frausto, \{M. Sigfrido\} and Gilbert Recinos-Mijangos and Reinchardt, \{John F.\} and \{Pamo Reyna\}, \{Oscar G.\} and Stuart Sarshik and Albretch Schilling and Tomera, \{Kevin M.\} and Yair Walzer and John Tuttle and Glen Wells and Alfredo Amenabar and Ian Baird and Bauwens, \{J. Eric\} and Gary Bergen and Paul Brownstone and Jaime Cajigas and Daniel Coto and Joshua Fierer and Nicolas Flores and Juan Gallego-Gomez and Lionel Gatien and David Gilbert and Abel Jasovich and Fernando Jimenez-Cruz and Danny Keiller and Nancy Khardori and Karl Kreder and Jose Mansa-Pueyo and Michael Marberger and Simon Mirelman and Daniel Pryluka and Michael Rauchenwald and Rikhotso, \{Lybon T.\} and Miguel Tallada-Bunnuel and Williams Weems and John Wegenke",

year = "2004",

month = jun,

doi = "10.1093/jac/dkh208",

language = "English",

volume = "53",

pages = "ii67--ii74",

journal = "Journal of Antimicrobial Chemotherapy",

issn = "0305-7453",

publisher = "Oxford University Press",

number = "SUPPL. 2",

}

Wells, WG, Woods, GL, Jiang, Q, Gesser, RM, Albertson, EA, Al-Ibrahim, MS, Burdman, EA, Burke, TF, Childs, S, Cox, C, Eng, RHK, Frank, E, Brooks Gainer, R, Gonzalez Fuenzalida, F, Gezon, JA, Herman, T, Jacoby, K, Krinsky, AH, Landau, RE, Moseley, W, Rangel-Frausto, MS, Recinos-Mijangos, G, Reinchardt, JF, Pamo Reyna, OG, Sarshik, S, Schilling, A, Tomera, KM, Walzer, Y, Tuttle, J, Wells, G, Amenabar, A, Baird, I, Bauwens, JE, Bergen, G, Brownstone, P, Cajigas, J, Coto, D, Fierer, J, Flores, N, Gallego-Gomez, J, Gatien, L, Gilbert, D, Jasovich, A, Jimenez-Cruz, F, Keiller, D, Khardori, N, Kreder, K, Mansa-Pueyo, J, Marberger, M, Mirelman, S, Pryluka, D, Rauchenwald, M, Rikhotso, LT, Tallada-Bunnuel, M, Weems, W & Wegenke, J 2004, 'Treatment of complicated urinary tract infection in adults: Combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy', Journal of Antimicrobial Chemotherapy, vol. 53, no. SUPPL. 2, pp. ii67-ii74. https://doi.org/10.1093/jac/dkh208

Treatment of complicated urinary tract infection in adults: Combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy. / Wells, Wilbur G.; Woods, Gail L.; Jiang, Qi et al.
In: Journal of Antimicrobial Chemotherapy, Vol. 53, No. SUPPL. 2, 06.2004, p. ii67-ii74.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Treatment of complicated urinary tract infection in adults

T2 - Combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy

AU - Wells, Wilbur G.

AU - Woods, Gail L.

AU - Jiang, Qi

AU - Gesser, Richard M.

AU - Albertson, Elizabeth A.

AU - Al-Ibrahim, Mohamed S.

AU - Burdman, Emmanuel A.

AU - Burke, Thomas F.

AU - Childs, Stacy

AU - Cox, Clair

AU - Eng, Robert H.K.

AU - Frank, Elliot

AU - Brooks Gainer, Robert

AU - Gonzalez Fuenzalida, Fernando

AU - Gezon, John A.

AU - Herman, Theodore

AU - Jacoby, Karny

AU - Krinsky, Andrew H.

AU - Landau, Richard E.

AU - Moseley, William

AU - Rangel-Frausto, M. Sigfrido

AU - Recinos-Mijangos, Gilbert

AU - Reinchardt, John F.

AU - Pamo Reyna, Oscar G.

AU - Sarshik, Stuart

AU - Schilling, Albretch

AU - Tomera, Kevin M.

AU - Walzer, Yair

AU - Tuttle, John

AU - Wells, Glen

AU - Amenabar, Alfredo

AU - Baird, Ian

AU - Bauwens, J. Eric

AU - Bergen, Gary

AU - Brownstone, Paul

AU - Cajigas, Jaime

AU - Coto, Daniel

AU - Fierer, Joshua

AU - Flores, Nicolas

AU - Gallego-Gomez, Juan

AU - Gatien, Lionel

AU - Gilbert, David

AU - Jasovich, Abel

AU - Jimenez-Cruz, Fernando

AU - Keiller, Danny

AU - Khardori, Nancy

AU - Kreder, Karl

AU - Mansa-Pueyo, Jose

AU - Marberger, Michael

AU - Mirelman, Simon

AU - Pryluka, Daniel

AU - Rauchenwald, Michael

AU - Rikhotso, Lybon T.

AU - Tallada-Bunnuel, Miguel

AU - Weems, Williams

AU - Wegenke, John

PY - 2004/6

Y1 - 2004/6

N2 - The efficacy and safety of parenteral ertapenem, a Group 1 carbapenem, 1 g once a day, for the treatment of complicated urinary tract infections (UTIs; i.e. acute pyelonephritis, UTI in men, or UTI associated with obstruction, foreign body or a urological abnormality interfering with normal voiding) in adults, were compared with those of parenteral ceftriaxone, 1 g once a day, in two similarly designed prospective, double-blind, randomized studies. In both studies, patients could be switched to an oral agent after ≥3 days of parenteral study therapy. At entry, 850 patients were stratified according to whether they had acute pyelonephritis or other complicated UTI without acute pyelonephritis. Two hundred and fifty-six patients in the ertapenem group and 224 in the ceftriaxone group were microbiologically evaluable. Ninety-six per cent of these patients were switched to oral therapy, usually ciprofloxacin; the median (range) duration of parenteral and total therapy, respectively, was 4 (2-14) days and 13 (14-18) days for ertapenem and 4 (2-14) days and 13 (3-17) days for ceftriaxone. The most common pathogens were Escherichia coli and Klebsiella pneumoniae, which accounted for 64.7% and 9.8% of isolates, respectively. At the primary efficacy endpoint 5-9 days after treatment, 229 (89.5%) patients who received ertapenem and 204 (91.1%) patients who received ceftriaxone had a favourable microbiological response (95% confidence interval, -7.4 to 4.0), indicating that outcomes in the two treatment groups were equivalent. Success rates in both treatment groups were similar when compared by stratum and severity of infection. The frequency and severity of drug-related adverse events were generally similar in both treatment groups. In this combined analysis, ertapenem was highly effective therapy for the treatment of complicated UTIs in adults with moderate-to-severe disease. JAC

AB - The efficacy and safety of parenteral ertapenem, a Group 1 carbapenem, 1 g once a day, for the treatment of complicated urinary tract infections (UTIs; i.e. acute pyelonephritis, UTI in men, or UTI associated with obstruction, foreign body or a urological abnormality interfering with normal voiding) in adults, were compared with those of parenteral ceftriaxone, 1 g once a day, in two similarly designed prospective, double-blind, randomized studies. In both studies, patients could be switched to an oral agent after ≥3 days of parenteral study therapy. At entry, 850 patients were stratified according to whether they had acute pyelonephritis or other complicated UTI without acute pyelonephritis. Two hundred and fifty-six patients in the ertapenem group and 224 in the ceftriaxone group were microbiologically evaluable. Ninety-six per cent of these patients were switched to oral therapy, usually ciprofloxacin; the median (range) duration of parenteral and total therapy, respectively, was 4 (2-14) days and 13 (14-18) days for ertapenem and 4 (2-14) days and 13 (3-17) days for ceftriaxone. The most common pathogens were Escherichia coli and Klebsiella pneumoniae, which accounted for 64.7% and 9.8% of isolates, respectively. At the primary efficacy endpoint 5-9 days after treatment, 229 (89.5%) patients who received ertapenem and 204 (91.1%) patients who received ceftriaxone had a favourable microbiological response (95% confidence interval, -7.4 to 4.0), indicating that outcomes in the two treatment groups were equivalent. Success rates in both treatment groups were similar when compared by stratum and severity of infection. The frequency and severity of drug-related adverse events were generally similar in both treatment groups. In this combined analysis, ertapenem was highly effective therapy for the treatment of complicated UTIs in adults with moderate-to-severe disease. JAC

KW - Acute pyelonephritis

KW - Antimicrobial agents

KW - Carbapenems

KW - Efficacy

KW - Safety

UR - https://www.scopus.com/pages/publications/3042546497

U2 - 10.1093/jac/dkh208

DO - 10.1093/jac/dkh208

M3 - Article

C2 - 15150185

SN - 0305-7453

VL - 53

SP - ii67-ii74

JO - Journal of Antimicrobial Chemotherapy

JF - Journal of Antimicrobial Chemotherapy

IS - SUPPL. 2

ER -

Wells WG, Woods GL, Jiang Q, Gesser RM, Albertson EA, Al-Ibrahim MS et al. Treatment of complicated urinary tract infection in adults: Combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy. Journal of Antimicrobial Chemotherapy. 2004 Jun;53(SUPPL. 2):ii67-ii74. doi: 10.1093/jac/dkh208

Treatment of complicated urinary tract infection in adults: Combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy

Abstract

UN SDGs

ASJC Scopus subject areas

Keywords

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