Evidence map›Paper›PMID 25031289›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2014

The efficacy and safety of gentamicin plus azithromycin and gemifloxacin plus azithromycin as treatment of uncomplicated gonorrhea.

Robert D Kirkcaldy, Hillard S Weinstock, Page C Moore, Susan S Philip, Harold C Wiesenfeld, John R Papp, Peter R Kerndt, Shacondra Johnson, Khalil G Ghanem, Edward W Hook

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00926796 (Randomized Clinical Trial Evaluating the Efficacy of Gentamicin/Azithromycin and Gemifloxacin/Azithromycin Combination Therapies as an Alternative Regimen for Uncomplicated Urogenital Gonorrhea), which is not on this map. Cited by 58 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 4 pooled it
11.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00926796 phase4completednot on this map

Randomized Clinical Trial Evaluating the Efficacy of Gentamicin/Azithromycin and Gemifloxacin/Azithromycin Combination Therapies as an Alternative Regimen for Uncomplicated Urogenital Gonorrhea

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2010 to 2013Enrolled614ConditionsGonorrhoeaArmsAzithromycin, Gentamicin, Gemifloxacin
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 4 syntheses or guidelines pooled it, 145 citations in OpenAlex.

  1. Pooled it
  2. Sexually Transmitted Infections Treatment Guidelines, 2021.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2021
    Guideline
  3. Pooled it
  4. Sexually transmitted diseases treatment guidelines, 2015.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2015
    Guideline
  5. Trial
  6. Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea: A Phase 2, Randomized, Dose-Ranging, Single-Oral Dose Evaluation.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Trial
  7. Trial
  8. Article
  9. Article
  10. Review
  11. Review
  12. Veterinary world · 2024
    Review
  13. Review
  14. Journal of clinical medicine · 2023
    Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Update to CDC's Treatment Guidelines for Gonococcal Infection, 2020.MMWR. Morbidity and mortality weekly report · 2020
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 1 country.

Robert D KirkcaldyDivision of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
Hillard S WeinstockDivision of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
Page C MooreDepartment of Biostatistics, University of Arkansas Medical Sciences, Little Rock.
Susan S PhilipSan Francisco Department of Public Health, California.
Harold C WiesenfeldUniversity of Pittsburgh and Allegheny County Health Department, Pennsylvania.
John R PappDivision of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
Peter R KerndtCounty of Los Angeles, Department of Public Health, California.
Shacondra JohnsonFHI360, Durham, North Carolina.
Khalil G GhanemJohns Hopkins University School of Medicine, Baltimore, Maryland.
Edward W HookUniversity of Alabama at Birmingham Jefferson County Department of Health, Birmingham, Alabama.
Centers for Disease Control and Prevention · USSan Francisco Department of Public Health · USAllegheny County · USFamily Health International 360 · USJefferson County Department of Health · USJohns Hopkins Medicine · USLos Angeles County Department of Public Health · USUniversity of Arkansas for Medical Sciences · US

Funding

PHS HHS HHSN 26620040073C
6 · The paper itself

Abstract

backgroundCeftriaxone 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.

methodsWe 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.

resultsMicrobiological 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.

conclusionsGentamicin/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.

Indexed as

Administration, OralAdolescentAdultAnti-Bacterial AgentsAzithromycinDrug-Related Side Effects and Adverse ReactionsDrug Therapy, CombinationFemaleFluoroquinolonesGastrointestinal DiseasesGemifloxacinGentamicinsGonorrheaHumansInjections, IntramuscularMaleAnti-Bacterial AgentsAzithromycinFluoroquinolonesGemifloxacinGentamicinsNaphthyridinesazithromycingemifloxacingentamicingonorrhea treatmentNeisseria gonorrhoeae

Identifiers

PMID25031289
PMCPMC4271098
OpenAlexW2097148145

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.