Evidence map›Paper›PMID 25526757›Full record

Trial reportThe Journal of infectious diseases2015

Randomized Trial of Periodic Presumptive Treatment With High-Dose Intravaginal Metronidazole and Miconazole to Prevent Vaginal Infections in HIV-negative Women.

R Scott McClelland, Jennifer E Balkus, Jeannette Lee, Omu Anzala, Joshua Kimani, Jane Schwebke, Vivian Bragg, Shelly Lensing, Lale Kavak

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
3.1field-weighted citation impact, top 9% 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

26 citing papers in PubMed, 49 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Mycoplasma genitalium Infection in Kenyan and US Women.Sexually transmitted diseases · 2018
    Trial
  5. Trial
  6. Trial
  7. Home Screening for Bacterial Vaginosis to Prevent Sexually Transmitted Diseases.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
    Trial
  8. Article
  9. Article
  10. Article
  11. Article
  12. A phase 3, randomized, controlled trial of Astodrimer 1% Gel for preventing recurrent bacterial vaginosis.European journal of obstetrics & gynecology and reproductive biology: X · 2021
    Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Vaginal microbiota and susceptibility to HIV.AIDS (London, England) · 2018
    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

9 authors at 7 institutions in 3 countries.

R Scott McClellandDepartment of Medicine Department of Epidemiology Department of Global Health, University of Washington Institute of Tropical and Infectious Diseases.
Jennifer E BalkusDepartment of Global Health, University of Washington Department of Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Jeannette LeeDepartment of Biostatistics, University of Arkansas for Medical Sciences, Little Rock.
Omu AnzalaKenya AIDS Vaccine Initiative, University of Nairobi.
Joshua KimaniInstitute of Tropical and Infectious Diseases.
Jane SchwebkeDivision of Infectious Diseases, University of Alabama at Birmingham.
Vivian BraggFHI360, Durham, North Carolina.
Shelly LensingDepartment of Biostatistics, University of Arkansas for Medical Sciences, Little Rock.
Lale KavakEmbil Pharmaceutical Company, Istanbul, Turkey.
University of Arkansas for Medical Sciences · USFamily Health International 360 · USHospital for Tropical Diseases · VNInfectious Disease Research Institute · USKenya AIDS Vaccine Initiative · KEUniversity of Alabama at Birmingham · USUniversity of Washington · US

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI EDWIN ROBERTO ORELLANA · 1988 to 2026
$104.9M
NIAID NIH HHS N01 AI040073NIAID NIH HHS P30 AI027757NIAID NIH HHS P30-AI27757PHS HHS HHSN266200400073C
6 · The paper itself

Abstract

backgroundVaginal infections are common, frequently recur, and may increase women's risk for sexually transmitted infections (STIs). We tested the efficacy of a novel regimen to prevent recurrent vaginal infections.

methodsHuman immunodeficiency virus (HIV)-negative women 18-45 years old with 1 or more vaginal infections, including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), or Trichomonas vaginalis (TV), were randomly assigned to receive vaginal suppositories containing metronidazole 750 mg plus miconazole 200 mg or matching placebo for 5 consecutive nights each month for 12 months. Primary endpoints, evaluated every 2 months, were BV (Gram stain) and VVC (positive wet mount and culture).

resultsParticipants (N = 234) were randomly assigned to the intervention (N = 118) or placebo (N = 116) arm. Two hundred seventeen (93%) women completed an end-of-study evaluation. The intervention reduced the proportion of visits with BV compared to placebo (21.2% vs 32.5%; relative risk [RR] 0.65, 95% confidence interval [CI] .48-.87). In contrast, the proportion of visits with VVC was similar in the intervention (10.4%) versus placebo (11.3%) arms (RR 0.92, 95% CI .62-1.37).

conclusionsMonthly treatment with intravaginal metronidazole plus miconazole reduced the proportion of visits with BV during 12 months of follow-up. Further study will be important to determine whether this intervention can reduce women's risk of STIs.

Indexed as

AdolescentAdultAnti-Infective AgentsCandidiasis, VulvovaginalChemopreventionFemaleHumansMetronidazoleMiconazoleMiddle AgedPlacebosPre-Exposure ProphylaxisTreatment OutcomeTrichomonas VaginitisVaginosis, BacterialYoung AdultAnti-Infective AgentsMetronidazoleMiconazolePlacebosbacterial vaginosismetronidazolemiconazoleperiodic presumptive treatmentTrichomonas vaginalisvulvovaginal candidiasis

Identifiers

PMID25526757
PMCPMC4836721
OpenAlexW2135769723

What OpenQuestion holds

Textmetadata
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.