TY - JOUR
T1 - The efficacy and safety of gentamicin plus azithromycin and gemifloxacin plus azithromycin as treatment of uncomplicated gonorrhea
AU - Participated in study conception and design, served as initial principal investigator; CDC
AU - Kirkcaldy, Robert D.
AU - Weinstock, Hillard S.
AU - Moore, Page C.
AU - Philip, Susan S.
AU - Wiesenfeld, Harold C.
AU - Papp, John R.
AU - Kerndt, Peter R.
AU - Johnson, Shacondra
AU - Ghanem, Khalil G.
AU - Hook, Edward W.
AU - Dowell, Deborah
AU - Harvey, Alesia
AU - Pettus, Kevin
AU - Sharpe, Samera
AU - Deal, Carolyn
AU - Glock, Jonathan
AU - Long, Jill
AU - Venkatasubramanian, Lalitha
AU - McNeil, Linda
AU - Perlowski, Linda Mc Neilcharlotte
AU - Lee, Jeannette Y.
AU - Lensing, Shelly
AU - Trainor, Nikole
AU - Fuller, Shannon
AU - Herrera, Amelia
AU - Carlson, Jonathan S.
AU - Harbison, Hanne
AU - Lenderman, Connie
AU - Dixon, Paula
AU - Whittington, Allison
AU - Macio, Ingrid
AU - Priest, Carol
AU - Jett, Abi
AU - Campbell, Tracy
AU - Uniyal, Apurva
AU - Royal, Lashawnda
AU - Mejia, Marisol
AU - Vonghack, Jennifer
AU - Tobias, Susan
AU - Zenilman, Jonathan
N1 - Funding Information:
Acknowledgments. The authors thank the patients involved in the study. Author contributions. R. D. K. and P. C. M. had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Disclaimer. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Financial support. This work was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (grant number HHSN 26620040073C). Potential conflicts of interest. All authors: No reported conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
Funding Information:
The study was designed by the investigators, the CDC, and the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health; sponsored by NIAID; and funded by NIAID and the CDC.
Funding Information:
Financial support. This work was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (grant number HHSN 26620040073C).
PY - 2014/10/15
Y1 - 2014/10/15
N2 - Background. Ceftriaxone is the foundation of currently recommended gonorrhea treatment. There is an urgent need for backup treatment options for patients with cephalosporin allergy or infections due to suspected cephalosporin- resistant Neisseria gonorrhoeae. We evaluated the efficacy and tolerability of 2 combinations of existing noncephalosporin antimicrobials for treatment of patients with urogenital gonorrhea. Methods. We conducted a randomized, multisite, open-label, noncomparative trial in 5 outpatient sexually transmitted disease clinic sites in Alabama, California, Maryland, and Pennsylvania. Patients aged 15 60 years diagnosed with uncomplicated urogenital gonorrhea were randomly assigned to either gentamicin 240 mg intramuscularly plus azithromycin 2 g orally, or gemifloxacin 320 mg orally plus azithromycin 2 g orally. The primary outcome was microbiological cure of urogenital infections (negative follow-up culture) at 10 17 days after treatment among 401 participants in the per protocol population. Results. Microbiological cure was achieved by 100% (lower 1-sided exact 95% confidence interval [CI] bound, 98.5%) of 202 evaluable participants receiving gentamicin/azithromycin, and 99.5% (lower 1-sided exact 95% CI bound, 97.6%) of 199 evaluable participants receiving gemifloxacin/azithromycin. Gentamicin/azithromycin cured 10 of 10 pharyngeal infections and 1 of 1 rectal infection; gemifloxacin/azithromycin cured 15 of 15 pharyngeal and 5 of 5 rectal infections. Gastrointestinal adverse events were common in both arms. Conclusions. Gentamicin/azithromycin and gemifloxacin/azithromycin were highly effective for treatment of urogenital gonorrhea. Gastrointestinal adverse events may limit routine use. These non-cephalosporin-based regimens may be useful alternative options for patients who cannot be treated with cephalosporin antimicrobials. Additional treatment options for gonorrhea are needed. Clinical Trials Registration. NCT00926796.
AB - Background. Ceftriaxone is the foundation of currently recommended gonorrhea treatment. There is an urgent need for backup treatment options for patients with cephalosporin allergy or infections due to suspected cephalosporin- resistant Neisseria gonorrhoeae. We evaluated the efficacy and tolerability of 2 combinations of existing noncephalosporin antimicrobials for treatment of patients with urogenital gonorrhea. Methods. We conducted a randomized, multisite, open-label, noncomparative trial in 5 outpatient sexually transmitted disease clinic sites in Alabama, California, Maryland, and Pennsylvania. Patients aged 15 60 years diagnosed with uncomplicated urogenital gonorrhea were randomly assigned to either gentamicin 240 mg intramuscularly plus azithromycin 2 g orally, or gemifloxacin 320 mg orally plus azithromycin 2 g orally. The primary outcome was microbiological cure of urogenital infections (negative follow-up culture) at 10 17 days after treatment among 401 participants in the per protocol population. Results. Microbiological cure was achieved by 100% (lower 1-sided exact 95% confidence interval [CI] bound, 98.5%) of 202 evaluable participants receiving gentamicin/azithromycin, and 99.5% (lower 1-sided exact 95% CI bound, 97.6%) of 199 evaluable participants receiving gemifloxacin/azithromycin. Gentamicin/azithromycin cured 10 of 10 pharyngeal infections and 1 of 1 rectal infection; gemifloxacin/azithromycin cured 15 of 15 pharyngeal and 5 of 5 rectal infections. Gastrointestinal adverse events were common in both arms. Conclusions. Gentamicin/azithromycin and gemifloxacin/azithromycin were highly effective for treatment of urogenital gonorrhea. Gastrointestinal adverse events may limit routine use. These non-cephalosporin-based regimens may be useful alternative options for patients who cannot be treated with cephalosporin antimicrobials. Additional treatment options for gonorrhea are needed. Clinical Trials Registration. NCT00926796.
KW - Azithromycin
KW - Gemifloxacin
KW - Gentamicin
KW - Gonorrhea treatment
KW - Neisseria gonorrhoeae
UR - http://www.scopus.com/inward/record.url?scp=84986268624&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84986268624&partnerID=8YFLogxK
U2 - 10.1093/cid/ciu521
DO - 10.1093/cid/ciu521
M3 - Article
C2 - 25031289
AN - SCOPUS:84986268624
SN - 1058-4838
VL - 59
SP - 1083
EP - 1091
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 8
ER -