178
Views
0
CrossRef citations to date
0
Altmetric
REVIEW

Safety Aspects and Rational Use of Single Intramuscular Dose Ceftriaxone: Clinical Insights on the Management of Uncomplicated Gonococcal Infections

ORCID Icon &
Pages 159-170 | Received 06 Jul 2023, Accepted 27 Oct 2023, Published online: 03 Nov 2023

References

  • World Health Organization. Multi-drug resistant gonorrhoea. Geneva: World Health Organization; 2023. Available from: https://www.who.int/news-room/fact-sheets/detail/multi-drug-resistant-gonorrhoea. Accessed June 16, 2023.
  • Centers for Disease Control and Prevention. Sexually transmitted disease surveillance 2021. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2023. Available from: https://www.cdc.gov/std/statistics/2021/default.htm. Accessed June 16, 2023.
  • Kirkcaldy RD, Weston E, Segurado AC, Hughes G. Epidemiology of gonorrhoea: a global perspective. Review Sex Health. 2019;16(5):401–411. doi:10.1071/SH19061
  • Rubin HF, Ross JDC, Grad YH. The frontiers of addressing antibiotic resistance in Neisseria gonorrhoeae. Transl Res. 2020;220:122–137. doi:10.1016/j.trsl.2020.02.002
  • Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States, 2013. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2013. Available from: https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf. Accessed June 17, 2023.
  • World Health Organization. Global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics. Geneva: World Health Organization; 2017. Available from: https://www.who.int/publications/i/item/WHO-EMP-IAU-2017.12. Accessed June 17, 2023.
  • Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States, 2019. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2019. Available from: https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf. Accessed June 17, 2023.
  • Dalke B, Ivers T, O’Brien KK, Castillo S, Hoie E, Begley K. Gonorrhea: treatment and management considerations for the male patient. US Pharm. 2016;41(8):41–44.
  • Detels R, Green AM, Klausner JD, et al. The incidence and correlates of symptomatic and asymptomatic Chlamydia trachomatis and Neisseria gonorrhoeae infections in selected populations in five countries. Sex Transm Dis. 2011;38(6):503–509. doi:10.1097/OLQ.0b013e318206c288
  • Morris SR, Klausner JD, Buchbinder SP, et al. Prevalence and incidence of pharyngeal gonorrhea in a longitudinal sample of men who have sex with men: the EXPLORE study. Clin Infect Dis. 2006;43(10):1284–1289. doi:10.1086/508460
  • Nettleton WD, Kent JB, Macomber K, et al. Ongoing cluster of highly related disseminated gonococcal infections—southwest Michigan, 2019. MMWR Morb Mortal Wkly Rep. 2020;69(12):353–354. doi:10.15585/mmwr.mm6912a5
  • Petro J. Sulphonamide resistance in gonorrhoea. Lancet. 1943;241(6228):35–38. doi:10.1016/S0140-6736(00)89071-6
  • Kampmeier RH. Introduction of sulfonamide therapy for gonorrhea. Sex Transm Dis. 1983;10(2):81–84. doi:10.1097/00007435-198304000-00007
  • Herrell WE, Cook EN, Thompson L. Use of penicillin in sulfonamide resistant gonorrheal infections. JAMA. 1943;122(5):289–292. doi:10.1001/jama.1943.02840220021005
  • Mahoney JF, Ferguson C, Buchholtz M, Van Slyke CJ. The use of penicillin sodium in the treatment of sulfonamide resistant gonorrhea in men. Am J Syph Gonor Ven Dis. 1943;27(5):525–528.
  • Thayer JD, Field FW, Magnuson HJ, Garson W. The sensitivity of Gonococci to penicillin and its relationship to penicillin failures. Antibiot Chemother. 1957;7(6):306–310.
  • Martin JE, Lester A, Price EV, Schmale JD. Comparative study of gonococcal susceptibility to penicillin in the United States, 1955–1969. J Infect Dis. 1970;122(5):459–461. doi:10.1093/infdis/122.5.459
  • Jaffe HW, Biddle JW, Thornsberry C, et al. National gonorrhea therapy monitoring study: in vitro antibiotic susceptibility and its correlation with treatment results. N Engl J Med. 1976;294(1):5–9. doi:10.1056/NEJM197601012940102
  • Centers for Disease Control and Prevention. Recommended treatment schedules for gonorrhea - March 1972. Morb Mortal Wkly Rep. 1972;21(10):82.
  • Boger WP, Beatty JO, Pitts FW, Flippin HF. The influence of a new benzoic acid derivative on the metabolism of para-aminosalicylic acid (PAS) and penicillin. Ann Intern Med. 1950;33(1):18–31.
  • Catlin BW. Probenecid: antibacterial action against Neisseria gonorrhoeae and interaction with benzylpenicillin. Antimicrob Agents Chemother. 1984;25(6):676–682. doi:10.1128/AAC.25.6.676
  • Centers for Disease Control and Prevention. 1985 STD treatment guidelines. MMWR Morb Mortal Wkly Rep. 1985;34(Suppl 4):75S–108S.
  • Centers for Disease Control and Prevention. Sentinel surveillance system for antimicrobial resistance in clinical isolates of Neisseria gonorrhoeae. MMWR Morb Mortal Wkly Rep. 1987;36(35):585–586,591–593.
  • Centers for Disease Control and Prevention. 1989 Sexually transmitted diseases treatment guidelines. MMWR Morb Mortal Wkly Rep. 1989;38(Suppl 8):1–43.
  • Centers for Disease Control and Prevention. 1993 Sexually transmitted diseases treatment guidelines. MMWR Recomm Rep. 1993;42(RR–14):1–102.
  • Centers for Disease Control and Prevention. 1998 Guidelines for treatment of sexually transmitted diseases. MMWR Recomm Rep. 1998;47(RR–1):1–118.
  • WHO Western Pacific Region Gonococcal Antimicrobial Surveillance Programme. Surveillance of antimicrobial resistance in Neisseria gonorrhoeae in the WHO Western Pacific Region, 1999. Commun Dis Intell. 2000;24(9):269–271.
  • Knapp JS, Neal SW, Parekh MC, Ohye R, Higa H, Rice RJ. Emerging in vitro resistance to quinolones in penicillinase-producing Neisseria gonorrhoeae strains in Honolulu, Hawaii. Antimicrob Agents Chemother. 1994;38(9):2200–2203. doi:10.1128/AAC.38.9.2200
  • Centers for Disease Control and Prevention. Fluoroquinolone-resistance in Neisseria gonorrhoeae, Hawaii, 1999, and decreased susceptibility to azithromycin in N. gonorrhoeae, Missouri, 1999. MMWR Morb Mortal Wkly Rep. 2002;49(37):833–837.
  • Centers for Disease Control and Prevention. Increases in fluoroquinolone-resistant Neisseria gonorrhoeae --- Hawaii and California, 2001. MMWR Morb Mortal Wkly Rep. 2002;51(46):1041–1044.
  • Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2002. MMWR Morb Mortal Wkly Rep. 2002;51(RR06):1–80.
  • Centers for Disease Control and Prevention. Increases in fluoroquinolone-resistant Neisseria gonorrhoeae among men who have sex with men --- United States, 2003, and revised recommendations for gonorrhea treatment, 2004. MMWR Morb Mortal Wkly Rep. 2004;53(16):335–338.
  • Centers for Disease Control and Prevention. Update to CDC’s sexually transmitted diseases treatment guidelines, 2006: fluoroquinolones no longer recommended for treatment of gonococcal infections. MMWR Morb Mortal Wkly Rep. 2007;56(14):332–336.
  • Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2010. MMWR Morb Mortal Wkly Rep. 2010;59(RR–12):1–110.
  • Centers for Disease Control and Prevention. Update to CDC’s sexually transmitted diseases treatment guidelines, 2010: oral cephalosporins no longer a recommended treatment for gonococcal infections. MMWR Morb Mortal Wkly Rep. 2012;61(31):590–594.
  • Allen VG, Seah C, Martin I, Melano RG. Azithromycin resistance is coevolving with reduced susceptibility to cephalosporins in Neisseria gonorrhoeae in Ontario, Canada. Antimicrob Agents Chemother. 2014;58(5):2528–2534. doi:10.1128/AAC.02608-13
  • Katz AR, Komeya AY, Soge OO, et al. Neisseria gonorrhoeae with high-level resistance to azithromycin: case report of the first isolate identified in the United States. Clin Infect Dis. 2012;54(6):841–843. doi:10.1093/cid/cir929
  • Centers for Disease Control and Prevention. Sexually transmitted disease surveillance 2018. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2019. Available from: https://www.cdc.gov/std/stats18/STDSurveillance2018-full-report.pdf. Accessed June 19, 2023.
  • Chisholm SA, Mouton JW, Lewis DA, Nichols T, Ison CA, Livermore DM. Cephalosporin MIC creep among gonococci: time for a pharmacodynamic rethink? J Antimicrob Chemother. 2010;65(10):2141–2148. doi:10.1093/jac/dkq289
  • Cyr S S, Barbee L, Workowski KA, et al. Update to CDC’s treatment guidelines for gonococcal infection, 2020. MMWR Morb Mortal Wkly Rep. 2020;69(50):1911–1916. doi:10.15585/mmwr.mm6950a6
  • Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1–187. doi:10.15585/mmwr.rr7004a1
  • Ong JJ, Bourne C, Dean JA. Australian sexually transmitted infection (STI) management guidelines for use in primary care 2022 update. Sex Health. 2023;20(1):1–8. doi:10.1071/SH22134
  • Public Health Agency of Canada. Sexually transmitted and blood-borne infections: Guides for health professionals. Ottowa, ON: Public Health Agency of Canada; 2023. Available from: https://www.canada.ca/en/public-health/services/infectious-diseases/sexual-health-sexually-transmitted-infections/canadian-guidelines.html. Accessed July 3, 2023.
  • Unemo M, Ross JDC, Serwin AB, Gomberg M, Cusini M, Jensen JS. 2020 European guideline for the diagnosis and treatment of gonorrhoea in adults. Int J STD AIDS. 2020;1:1–17.
  • Fifer H, Saunders J, Soni S, Sadiq ST, FitzGerald M. 2018 UK national guideline for the management of infection with Neisseria gonorrhoeae. Int J STD AIDS. 2020;31(1):4–15. doi:10.1177/0956462419886775
  • World Health Organization. WHO guidelines for the treatment of Neisseria gonorrhoeae. Geneva: World Health Organization; 2016. Available from: https://www.who.int/publications/i/item/9789241549691. Accessed June 16, 2023.
  • Unemo M, Shafer WM. Antimicrobial resistance in Neisseria gonorrhoeae in the 21st century: past, evolution, and future. Clin Microbiol Rev. 2014;27(3):587–613. doi:10.1128/CMR.00010-14
  • Unemo M, Del Rio C, Shafer WM. Antimicrobial resistance expressed by Neisseria gonorrhoeae: a major global public health problem in the 21st century. Microbiol Spectr. 2016;4(3):10.1128/microbiolspec.EI10-0009–2015.
  • Johnson SR, Morse SA. Antibiotic resistance in Neisseria gonorrhoeae: genetics and mechanisms of resistance. Sex Transm Dis. 1988;15(4):217–224. doi:10.1097/00007435-198810000-00008
  • Averett DR, Roth B, Burchall JJ, Baccanari DP. Dihydrofolate reductase from Neisseria sp. Antimicrob Agents Chemother. 1979;15(3):428–435. doi:10.1128/AAC.15.3.428
  • González N, Gyonne J, Laumen E, et al. Pre-exposure to azithromycin enhances gonococcal resilience to subsequent ciprofloxacin exposure: an in vitro study. F1000Res. 2022;11:1464. doi:10.12688/f1000research.126078.1
  • Zhao S, Duncan M, Tomberg J, Davies C, Unemo M, Nicholas RA. Genetics of chromosomally mediated intermediate resistance to ceftriaxone and cefixime in Neisseria gonorrhoeae. Antimicrob Agents Chemother. 2009;53(9):3744–3751. doi:10.1128/AAC.00304-09
  • Balduck M, Gyonne J, Laumen E, et al. Tolerance to ceftriaxone in Neisseria gonorrhoeae: rapid Induction in WHO P reference strain and detection in clinical isolates. Antibiotics. 2022;11(11):1480. doi:10.3390/antibiotics11111480
  • Kueakulpattana N, Wannigama DL, Luk-In S, et al. Multidrug-resistant Neisseria gonorrhoeae infection in heterosexual men with reduced susceptibility to ceftriaxone, first report in Thailand. Sci Rep. 2021;11(1):21659. doi:10.1038/s41598-021-00675-y
  • Handsfield HH, McCutchan JA, Corey L, Ronald AR. Evaluation of new anti-infective drugs for the treatment of uncomplicated gonorrhea in adults and adolescents. Infectious Diseases Society of America and the Food and Drug Administration. Clin Infect Dis. 1992;15(Suppl 1):S123–S130. doi:10.1093/clind/15.Supplement_1.S123
  • Moran JS, Levine WC. Drugs of choice for the treatment of uncomplicated gonococcal infections. Clin Infect Dis. 1995;20(Suppl 1):S47–S65. doi:10.1093/clinids/20.Supplement_1.S47
  • Newman LM, Moran JS, Workowski KA. Update on the management of gonorrhea in adults in the United States. Clin Infect Dis. 2007;44(Suppl 3):S84–S101. doi:10.1086/511422
  • Hook EW, Newman L, Drusano G, et al. Development of new antimicrobials for urogenital gonorrhea therapy: clinical trial design considerations. Clin Infect Dis. 2020;70(7):1495–1500. doi:10.1093/cid/ciz899
  • Handsfield HH, Murphy V. Comparative study of ceftriaxone and spectinomycin for treatment of uncomplicated gonorrhoea in men. Lancet. 1983;322(8341):67–70. doi:10.1016/S0140-6736(83)90058-2
  • Judson F, Ehret J, Root C. Comparative study of ceftriaxone and aqueous procaine penicillin G in the treatment of uncomplicated gonorrhea in women. Antimicrob Agents Chemother. 1983;23(2):218–220. doi:10.1128/AAC.23.2.218
  • Zajdowicz T, Sanches P, Berg S, Kerbs S, Newquist R, Harrison W. Comparison of ceftriaxone with cefoxitin in the treatment of penicillin-resistant gonococcal urethritis. Sex Transm Infect. 1983;59(3):176–178. doi:10.1136/sti.59.3.176
  • Judson FN, Ehret JM, Handsfield HH. Comparative study of ceftriaxone and spectinomycin for treatment of pharyngeal and anorectal gonorrhea. JAMA. 1985;253(10):1417–1419. doi:10.1001/jama.1985.03350340069019
  • Panikabutra K, Ariyarit C, Chitwarakorn A, Saensanoh C, Wongba C. Randomised comparative study of ceftriaxone and spectinomycin in gonorrhoea. Sex Transm Infect. 1985;61(2):106–108. doi:10.1136/sti.61.2.106
  • Dixon CA, Bittiner JB, Shahidullah M, Slack RC, Sulaiman MZ. Randomised observer blind comparative trial of ceftriaxone and penicillin in treating uncomplicated gonorrhoea in men and women. Genitourin Med. 1986;62(2):78–81. doi:10.1136/sti.62.2.78
  • Baddour LM, Busby L, Shapiro E, Cox KB, Glassco S, Johnson JK. Evaluation of treatment with single-dose ampicillin/sulbactam with probenecid or ceftriaxone in patients with uncomplicated gonorrhea. Sex Transm Dis. 1992;19(6):341–345. doi:10.1097/00007435-199211000-00009
  • McCormack WM, Mogabgab WJ, Jones RB, Wendel JG, Handsfield H. Multicenter, comparative study of cefotaxime and ceftriaxone for treatment of uncomplicated gonorrhea. Sex Transm Dis. 1993;20(5):269–273. doi:10.1097/00007435-199309000-00006
  • de Vries HJC, de Laat M, Jongen VW, et al. Efficacy of ertapenem, gentamicin, fosfomycin, and ceftriaxone for the treatment of anogenital gonorrhoea (NABOGO): a randomised, non-inferiority trial. Lancet Infect Dis. 2022;22:706–717. doi:10.1016/S1473-3099(21)00625-3
  • Ross JDC, Brittain C, Cole M, et al. Gentamicin compared with ceftriaxone for the treatment of gonorrhoea (G-ToG): a randomised non-inferiority trial. Lancet. 2019;393(10190):2511–2520. doi:10.1016/S0140-6736(18)32817-4
  • Eyre DW, Sanderson ND, Lord E, et al. Gonorrhoea treatment failure caused by a Neisseria gonorrhoeae strain with combined ceftriaxone and high-level azithromycin resistance, England, February 2018. Euro Surveill. 2018;23(27):1800323. doi:10.2807/1560-7917.ES.2018.23.27.1800323
  • Eyre DW, Town K, Street T, et al. Detection in the United Kingdom of the Neisseria gonorrhoeae FC428 clone, with ceftriaxone resistance and intermediate resistance to azithromycin, October to December 2018. Euro Surveill. 2019;24(10):1900147. doi:10.2807/1560-7917.ES.2019.24.10.1900147
  • Hook EW, Golden MR, Taylor SN, et al. Efficacy and safety of single-dose oral delafloxacin compared with intramuscular ceftriaxone for uncomplicated gonorrhea treatment: an open-label, noninferiority, Phase 3, multicenter, randomized study. Sex Transm Dis. 2019;46(5):279–286. doi:10.1097/OLQ.0000000000000971
  • Taylor SN, Morris DH, Avery AK, et al. Gepotidacin for the treatment of uncomplicated urogenital gonorrhea: a phase 2, randomized, dose-ranging, single-oral dose evaluation. Clin Infect Dis. 2018;67(4):504–512. doi:10.1093/cid/ciy145
  • Taylor SN, Marrazzo J, Batteiger BE, et al. Single-dose zoliflodacin (ETX0914) for treatment of urogenital gonorrhea. N Engl J Med. 2018;379(19):1835–1845. doi:10.1056/NEJMoa1706988
  • Centers for Disease Control and Prevention. Sexually transmitted disease surveillance 2020: Gonococcal Isolate Surveillance Project National Profile. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2022. Available from: https://www.cdc.gov/std/statistics/gisp-profiles/default.htm. Accessed June 16, 2023.
  • Van Gerwen OT, Muzny CA, Marrazzo JM. Sexually transmitted infections and female reproductive health. Nat Microbiol. 2022;7(8):1116–1126. doi:10.1038/s41564-022-01177-x
  • Ohnishi M, Saika T, Hoshina S, et al. Ceftriaxone-resistant Neisseria gonorrhoeae, Japan. Emerg Infect Dis. 2011;17(1):148–149. doi:10.3201/eid1701.100397
  • Ohnishi M, Golparian D, Shimuta K, et al. Is Neisseria gonorrhoeae initiating a future era of untreatable gonorrhea?: detailed characterization of the first strain with high-level resistance to ceftriaxone. Antimicrob Agents Chemother. 2011;55(7):3538–3545. doi:10.1128/AAC.00325-11
  • Pleininger S, Indra A, Golparian D, et al. Extensively drug-resistant (XDR) Neisseria gonorrhoeae causing possible gonorrhoea treatment failure with ceftriaxone plus azithromycin in Austria, April 2022. Euro Surveill. 2022;27(24):2200455. doi:10.2807/1560-7917.ES.2022.27.24.2200455
  • Berçot B, Caméléna F, Mérimèche M, et al. Ceftriaxone-resistant, multidrug-resistant Neisseria gonorrhoeae with a novel mosaic penA-237.001 gene, France, June 2022. Euro Surveill. 2022;27(50):2200899. doi:10.2807/1560-7917.ES.2022.27.50.2200899
  • Caruso C, Valluzzi RL, Colantuono S, Gaeta F, Romano A. β-Lactam allergy and cross-reactivity: a clinician’s guide to selecting an alternative antibiotic. J Asthma Allergy. 2021;14:31–46. doi:10.2147/JAA.S242061
  • Jani YH, Williams I, Krishna MT. Sustaining and spreading penicillin allergy delabelling: a narrative review of the challenges for service delivery and patient safety. Br J Clin Pharmacol. 2020;86(3):548–559. doi:10.1111/bcp.14190
  • Macy E, Blumenthal KG. Are cephalosporins safe for use in penicillin allergy without prior allergy evaluation? J Allergy Clin Immunol Pract. 2018;6(1):82–89. doi:10.1016/j.jaip.2017.07.033