The outcomes of a randomized managed trial carried out in Europe point out {that a} widespread bacterial an infection in girls may very well be handled with out antibiotics.
The trial investigated the efficacy of the broad-spectrum antiseptic dequalinium chloride for treating bacterial vaginosis (BV), which impacts an estimated 25% of reproductive-age girls and has a excessive recurrence charge attributed to bacterial biofilm. The usual remedies are the antibiotics clindamycin and metronidazole.
The outcomes, printed yesterday in JAMA Community Open, confirmed that compared with metronidazole, dequalinium chloride was not solely noninferior but additionally had higher tolerability and fewer antagonistic occasions. The investigators additionally be aware that whereas dequalinium chloride has been in the marketplace for 30 years, there aren’t any stories of clinically related resistance.
“Dequalinium chloride might assist cut back antibiotic consumption and thus warrants consideration as first-line remedy for BV as a result of its broad spectrum, efficacy, security, tolerability, and fewer probability of resistance,” the examine authors wrote.
Equally efficient, extra tolerable than antibiotics
The part 4 trial enrolled girls aged 18 and older with symptomatic BV from 11 gynecology practices and 1 hospital in Poland, the Czech Republic, and Slovakia from July 29, 2021, to August 25, 2022, with a 1-month follow-up. Sufferers had been randomized 1:1 to obtain dequalinium chloride vaginal tablets (10 mg as soon as each day for six days) or oral metronidazole (500 mg each day for 7 days).
The first end result measure was a noninferiority margin of 15 proportion factors within the absolute distinction in medical treatment charges between dequalinium chloride and metronidazole 7 to 11 days after remedy within the intention-to-treat (ITT) and per-protocol (PP) populations. Investigators additionally assessed tolerability and security.
Of the 147 girls (imply age, 36.7 years) enrolled within the trial, 72 had been handled with dequalinium chloride and 75 with metronidazole. The medical treatment charge within the ITT inhabitants was 64 of 69 (92.8%) within the dequalinium chloride group and 69 of 74 (93.2%) within the metronidazole group, with an absolute distinction in treatment charges of –0.5 proportion factors (95% confidence interval [CI], –10.8% to 9.8%).Â
Dequalinium chloride might assist cut back antibiotic consumption and thus warrants consideration as first-line remedy for BV as a result of its broad spectrum, efficacy, security, tolerability, and fewer probability of resistance.
Within the PP inhabitants, the medical treatment charges had been 54 of 58 (93.1%) for the dequalinium chloride group and 48 of 53 (90.6%) within the metronidazole group, with an absolute distinction of two.5 proportion factors (95% CI, –9.4 to 14.4 proportion factors).
“These outcomes verify the noninferiority of dequalinium chloride,” the authors wrote.
Evaluation at a second go to 20 to 40 days after remedy discovered that the treatment charges had been decrease for each remedies (79.7% vs 87.3%), however dequalinium chloride remained noninferior.
Thirty of fifty (60%) sufferers rated the tolerability of dequalinium chloride as excellent, in contrast with solely 21 of 54 (38.9%) sufferers who acquired metronidazole. Remedy-emergent antagonistic occasions had been reported by 8 sufferers within the dequalinium chloride group and 15 within the metronidazole group. None had been thought of severe, however three sufferers handled with metronidazole suspended remedy as a result of antagonistic occasions.
Various remedies wanted
The trial is the second to seek out that dequalinium chloride is noninferior to the first-line antibiotic remedies for BV. An earlier trial discovered it was as efficient as clindamycin. Though it is not authorized by the US Meals and Drug Administration, dequalinium chloride has been utilized in Europe for many years and is really useful by worldwide and European tips instead remedy for BV.
In a commentary that accompanies the examine, researchers from the College of Maryland Faculty of Drugs and the Johns Hopkins College Faculty of Drugs say the findings from the 2 trials counsel dequalinium chloride may very well be a much-needed various remedy for BV. However they spotlight three necessary proof gaps.
The primary is that the 2 trials had been carried out in Europe, and vaginal microbiota composition and response to dequalinium chloride could differ regionally. The second is the shortage of long-term information on BV recurrence following remedy with dequalinium chloride. Lastly, information on the protection of intravaginal dequalinium chloride in pregnant girls is restricted.
They name for strong medical trials to assist fill these gaps and increase remedy choices.
“It’s crucial that we increase the toolkit of accessible BV remedies,” the authors wrote. “Alternate options which might be at the very least as efficient as nitroimidazoles and clindamycin could be welcome additions. Therapies that impact a long-lasting treatment could be paradigm-shifting.”
