Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.
Administration, Intravaginal
Adolescent
Adult
Anti-Bacterial Agents
/ administration & dosage
Antibiosis
Double-Blind Method
Female
Gels
Humans
Incidence
Lactobacillus crispatus
/ isolation & purification
Metronidazole
/ therapeutic use
Middle Aged
Secondary Prevention
Vagina
/ microbiology
Vaginosis, Bacterial
/ epidemiology
Young Adult
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
14 05 2020
14 05 2020
Historique:
entrez:
14
5
2020
pubmed:
14
5
2020
medline:
23
5
2020
Statut:
ppublish
Résumé
Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis. We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).
Sections du résumé
BACKGROUND
Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis.
METHODS
We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of
RESULTS
A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit,
CONCLUSIONS
The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).
Identifiants
pubmed: 32402161
doi: 10.1056/NEJMoa1915254
pmc: PMC7362958
mid: NIHMS1597460
doi:
Substances chimiques
Anti-Bacterial Agents
0
Gels
0
Metronidazole
140QMO216E
Banques de données
ClinicalTrials.gov
['NCT02766023']
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
1906-1915Subventions
Organisme : NIAID NIH HHS
ID : HHSN272201300011C
Pays : United States
Organisme : NIAID NIH HHS
ID : HHSN272201300014C
Pays : United States
Organisme : NIAID NIH HHS
ID : HHSN272201300014I
Pays : United States
Organisme : National Institute of Allergy and Infectious Diseases
ID : HHSN272201300014I/HHSN27200007
Pays : International
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2020 Massachusetts Medical Society.
Références
J Infect Dis. 2006 Jun 1;193(11):1478-86
pubmed: 16652274
Placenta. 2019 Apr;79:30-39
pubmed: 31047708
Sex Transm Dis. 2012 Sep;39(9):710-2
pubmed: 22902667
Immunity. 2017 Jan 17;46(1):29-37
pubmed: 28087240
FEMS Microbiol Lett. 2019 Feb 1;366(4):
pubmed: 30715301
N Engl J Med. 1988 Oct 13;319(15):972-8
pubmed: 3262199
J Infect Dis. 1999 Dec;180(6):1863-8
pubmed: 10558942
Cochrane Database Syst Rev. 2009 Oct 07;(4):CD006289
pubmed: 19821358
Trials. 2015 Jul 26;16:315
pubmed: 26210791
J Clin Microbiol. 2003 May;41(5):1881-7
pubmed: 12734221
J Int AIDS Soc. 2019 May;22(5):e25300
pubmed: 31144462
J Infect Dis. 2009 May 15;199(10):1506-13
pubmed: 19331578
Sci Rep. 2020 Mar 3;10(1):3884
pubmed: 32127550
J Clin Microbiol. 1991 Feb;29(2):297-301
pubmed: 1706728
Sex Transm Dis. 2010 Dec;37(12):745-50
pubmed: 20644497
Am J Obstet Gynecol. 1996 Aug;175(2):435-41
pubmed: 8765265
Sex Transm Dis. 2009 Sep;36(9):564-9
pubmed: 19543144
Clin Infect Dis. 2011 May;52(10):1212-7
pubmed: 21498386
Am J Obstet Gynecol. 1988 Apr;158(4):819-28
pubmed: 3259075
Obstet Gynecol. 2007 Jan;109(1):114-20
pubmed: 17197596
Infect Dis Obstet Gynecol. 2007;2007:35387
pubmed: 18288237
J Infect Dis. 2015 Jun 15;211(12):1875-82
pubmed: 25526757
PLoS Med. 2012;9(6):e1001251
pubmed: 22745608
PLoS One. 2013 Sep 11;8(9):e74378
pubmed: 24040236
BJOG. 2020 Jan;127(2):287-299
pubmed: 31299136
Sex Transm Dis. 2019 May;46(5):304-311
pubmed: 30624309
Sex Transm Dis. 2011 Nov;38(11):1020-7
pubmed: 21992977