Evidence map›Paper›PMID 33298143›Full record

ArticleTrials2020

Clinical trial protocol to evaluate the efficacy of cefixime in the treatment of early syphilis.

Shivani N Mehta, Chrysovalantis Stafylis, David M Tellalian, Pamela L Burian, Cliff M Okada, Carl E Millner, Christopher M Mejia, Jeffrey D Klausner

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03660488 (Clinical Trial Evaluating the Clinical Efficacy of Cefixime for Treatment of Early Syphilis), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 38% 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.

NCT03660488 phase2completednot on this map

Clinical Trial Evaluating the Clinical Efficacy of Cefixime for Treatment of Early Syphilis

TypeinterventionalSponsorUniversity of California, Los AngelesRan2018 to 2021Enrolled58ConditionsSyphilis, Early SyphilisArmsCefixime 400 milligram Oral Capsule [Suprax], Benzathine Penicillin G
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Shivani N MehtaDepartment of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.ORCID http://orcid.org/0000-0002-5347-0159
Chrysovalantis StafylisDepartment of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
David M TellalianDepartment of Medicine, AIDS Healthcare Foundation, Los Angeles, CA, USA.
Pamela L BurianDepartment of Medicine, AIDS Healthcare Foundation, Los Angeles, CA, USA.
Cliff M OkadaDepartment of Medicine, AIDS Healthcare Foundation, Los Angeles, CA, USA.
Carl E MillnerDepartment of Medicine, AIDS Healthcare Foundation, Los Angeles, CA, USA.
Christopher M MejiaPublic Health Division, AIDS Healthcare Foundation, Los Angeles, CA, USA.
Jeffrey D KlausnerDepartment of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. JDKlausner@mednet.ucla.edu.
AIDS Healthcare Foundation · USUniversity of California, Los Angeles · US

Funding

UCLA Clinical Translational Science InstituteUL1TR001881 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ARLEEN F. BROWN, ARASH NAEIM · 2016 to 2026
$118.1M
NCATS NIH HHS UL1 TR001881
6 · The paper itself

Abstract

backgroundSyphilis rates have been increasing both in the USA and internationally with incidence higher among men-who-have-sex-with-men and people living with human immunodeficiency virus (HIV) infection. Currently, benzathine penicillin is the recommended treatment for syphilis in all patients. Global shortages and cost increases in benzathine penicillin call for alternative treatment options. This study evaluates the efficacy of oral cefixime for the treatment of early syphilis.

methodsWe are conducting a randomized, multisite, open-label, non-comparative clinical trial in Los Angeles and Oakland, CA. Eligible participants are ≥ 18 years old, with primary, secondary, or early latent syphilis (rapid plasma reagin [RPR] titer ≥ 1:8). Patients with HIV infection must have a viral load ≤ 200 copies/mL and CD4+ T cell count ≥ 350 cells/μL during the past 6 months. Participants are randomized to receive either 2.4 M IU benzathine penicillin G intramuscularly once or cefixime 400 mg orally twice a day for 10 days. Participants return at 3, 6, and 12 months post-treatment for follow-up RPR serological testing. The primary outcome is the proportion of participants who achieve ≥ 4-fold RPR titer decrease at 3 or 6 months post-treatment. DISCUSSION: Clinical trials evaluating the efficacy of alternative antibiotics to penicillin are urgently needed.

trial registrationClinicaltrials.gov NCT03660488 . Registered on 4 September 2018.

Indexed as

HIV InfectionsSexual and Gender MinoritiesSyphilisAdolescentAnti-Bacterial AgentsCefiximeHomosexuality, MaleHumansMaleRandomized Controlled Trials as TopicAnti-Bacterial AgentsCefiximeCefiximeClinical trialEarly syphilisPenicillinSyphilisTreponema pallidum

Identifiers

PMID33298143
PMCPMC7725115
OpenAlexW3113322610

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.