Evidence map›Paper›PMID 30418536›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2019

Disseminated Gonococcal Infections in Patients Receiving Eculizumab: A Case Series.

Page E Crew, Winston E Abara, Lynda McCulley, Peter E Waldron, Robert D Kirkcaldy, Emily J Weston, Kyle T Bernstein, S Christopher Jones, Susan J Bersoff-Matcha

Open access · bronzeAbstract readCase Reports
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
5.2field-weighted citation impact, top 4% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 85 citations in OpenAlex.

  1. Sexually Transmitted Infections Treatment Guidelines, 2021.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2021
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  13. Sexually Transmitted Infections in People with Human Immunodeficiency Virus.Infectious disease clinics of North America · 2024
    Review
  14. Article
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  16. Journal of clinical medicine · 2023
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Page E CrewDivision of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland.
Winston E AbaraDivision of Sexually Transmitted Disease (STD) Prevention, National Center for Human Immunodeficiency Virus (HIV)/AIDS, Viral Hepatitis, STD and Tuberculosis Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
Lynda McCulleyDivision of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland.
Peter E WaldronDivision of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland.
Robert D KirkcaldyDivision of Sexually Transmitted Disease (STD) Prevention, National Center for Human Immunodeficiency Virus (HIV)/AIDS, Viral Hepatitis, STD and Tuberculosis Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
Emily J WestonDivision of Sexually Transmitted Disease (STD) Prevention, National Center for Human Immunodeficiency Virus (HIV)/AIDS, Viral Hepatitis, STD and Tuberculosis Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
Kyle T BernsteinDivision of Sexually Transmitted Disease (STD) Prevention, National Center for Human Immunodeficiency Virus (HIV)/AIDS, Viral Hepatitis, STD and Tuberculosis Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
S Christopher JonesDivision of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland.
Susan J Bersoff-MatchaDivision of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland.
United States Food and Drug Administration · USCenters for Disease Control and Prevention · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

backgroundGonorrhea is the second most commonly reported notifiable condition in the United States. Infrequently, Neisseria gonorrhoeae can cause disseminated gonococcal infection (DGI). Eculizumab, a monoclonal antibody, inhibits terminal complement activation, which impairs the ability of the immune system to respond effectively to Neisseria infections. This series describes cases of N. gonorrhoeae infection among patients receiving eculizumab.

methodsPre- and postmarketing safety reports of N. gonorrhoeae infection in patients receiving eculizumab worldwide were obtained from US Food and Drug Administration safety databases and the medical literature, including reports from the start of pivotal clinical trials in 2004 through 31 December 2017. Included patients had at least 1 eculizumab dose within the 3 months prior to N. gonorrhoeae infection.

resultsNine cases of N. gonorrhoeae infection were identified; 8 were classified as disseminated (89%). Of the disseminated cases, 8 patients required hospitalization, 7 had positive blood cultures, and 2 required vasopressor support. One patient required mechanical ventilation. Neisseria gonorrhoeae may have contributed to complications prior to death in 1 patient; however, the fatality was attributed to underlying disease per the reporter.

conclusionsPatients receiving eculizumab may be at higher risk for DGI than the general population. Prescribers are encouraged to educate patients receiving eculizumab on their risk for serious gonococcal infections and perform screening for sexually transmitted diseases (STDs) per the Centers for Disease Control and Prevention STD treatment guidelines or in suspected cases. If antimicrobial prophylaxis is used during eculizumab therapy, prescribers should consider trends in gonococcal antimicrobial susceptibility due to emerging resistance concerns.

Indexed as

Neisseriaceae InfectionsAdolescentAdultAntibodies, Monoclonal, HumanizedComplement Inactivating AgentsFemaleGonorrheaHumansImmunocompromised HostYoung AdultAntibodies, Monoclonal, HumanizedComplement Inactivating Agentseculizumabdisseminated gonococcal infectioneculizumabgonorrhea

Identifiers

PMID30418536
PMCPMC6744347
OpenAlexW2901128710

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.