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Expert Review of Anti-infective Therapy Aug 2022Single-dose 2-g oral secnidazole (SEC), newly approved by the U.S. Food and Drug administration (FDA) for treatment of trichomoniasis, is a potent 5-nitroimidazole with...
INTRODUCTION
Single-dose 2-g oral secnidazole (SEC), newly approved by the U.S. Food and Drug administration (FDA) for treatment of trichomoniasis, is a potent 5-nitroimidazole with selective toxicity against various micro-organisms. It has been used internationally to treat trichomoniasis, bacterial vaginosis, and other infections for decades. Trichomoniasis is the most common non-viral sexually transmitted infection worldwide and is associated with significant morbidity. In comparison to the only other FDA-approved treatments for trichomoniasis in the United States - metronidazole and tinidazole - SEC has favorable pharmacokinetics, including a longer half-life and a lower minimal lethal concentration.
AREAS COVERED
This work summarizes the chemistry and pharmacology of SEC and reviews the evidence on its efficacy, tolerability, and safety for the treatment of trichomoniasis.
EXPERT OPINION
SEC is an efficacious, well tolerated, and safe treatment for patients aged ≥12 years with trichomoniasis. Single-dose administration makes it a favorable treatment option, especially in cases where adherence to multi-dose treatment regimens may be low.
Topics: Adolescent; Adult; Female; Humans; Metronidazole; Nitroimidazoles; Trichomonas Infections; Trichomonas Vaginitis; Trichomonas vaginalis; United States; Vaginosis, Bacterial
PubMed: 35642509
DOI: 10.1080/14787210.2022.2080656 -
The Lancet. Microbe Jun 2022Bacterial vaginosis might increase HIV risk by eliciting genital inflammation and epithelial barrier disruption, whereas vaginal Lactobacillus crispatus is associated... (Randomized Controlled Trial)
Randomized Controlled Trial
Sustained effect of LACTIN-V (Lactobacillus crispatus CTV-05) on genital immunology following standard bacterial vaginosis treatment: results from a randomised, placebo-controlled trial.
BACKGROUND
Bacterial vaginosis might increase HIV risk by eliciting genital inflammation and epithelial barrier disruption, whereas vaginal Lactobacillus crispatus is associated with immune quiescence and HIV protection. We investigated the effect of a live biotherapeutic containing L crispatus CTV-05 (LACTIN-V) on genital immunology and key vaginal bacteria.
METHODS
This substudy included women aged 18-45 years who participated in the randomised, placebo-controlled, phase 2b trial of LACTIN-V to reduce bacterial vaginosis recurrence, conducted at four universities and hospitals in the USA. Women with negative results for sexually transmitted infection, pregnancy, and urinary tract infection were provided a 5-day course of vaginal metronidazole 0·75% gel. Those who met at least three of four clinical Amsel criteria for bacterial vaginosis and had a Nugent score of 4-10 from Gram staining were eligible. Participants in the LACTIN-V trial were randomly assigned (2:1) to receive either LACTIN-V or placebo, applied vaginally once per day for 5 days during the first week and then twice per week for 10 more weeks. Follow-up visits occurred 4, 8, 12, and 24 weeks after enrolment. Soluble immune factors and the absolute abundance of bacterial taxa were assayed by mutliplex ELISA and quantitative PCR. The primary outcomes were vaginal levels of IL-1α and soluble E-cadherin at 24 weeks (ie, 13 weeks after treatment cessation).
FINDINGS
Between Feb 21, 2020 and March 18, 2021, we characterised genital immune parameters and the vaginal microbiota in a subset of 66 highly adherent participants who were randomly selected, with no exclusion criteria, from those who had attended all study follow-up visits (n=166) in the larger LACTIN-V clinical trial (n=288). 32 (48%) participants received LACTIN-V and 34 (52%) received placebo. LACTIN-V treatment was significantly associated with lower concentrations of the proinflammatory cytokine IL-1α (β coefficient 0·310, SE 0·149; p=0·042) and soluble E-cadherin (0·429, 0·199; p=0·035), a biomarker of epithelial barrier disruption.
INTERPRETATION
Vaginal administration of LACTIN-V following standard bacterial vaginosis therapy resulted in a sustained reduction in genital inflammation and a biomarker of epithelial integrity. The potential of LACTIN-V to reduce HIV susceptibility merits further investigation.
FUNDING
Canadian Institutes of Health Research and the National Institutes of Health National Institute of Allergy and Infectious Diseases.
Topics: Bacteria; Cadherins; Canada; Female; HIV Infections; Humans; Inflammation; Lactobacillus crispatus; Metronidazole; United States; Vagina; Vaginosis, Bacterial
PubMed: 35659905
DOI: 10.1016/S2666-5247(22)00043-X -
Journal of Infection in Developing... Mar 2020Endolimax nana is a commensal protozoan of the colon. We report a case of chronic urticaria associated with E. nana in a 34-year-old Italian woman. The patient suffered...
Endolimax nana is a commensal protozoan of the colon. We report a case of chronic urticaria associated with E. nana in a 34-year-old Italian woman. The patient suffered from abdominal pain, diarrhoea and weight loss. The disease appeared after a trip to Vietnam. Laboratory examinations showed mild blood eosinophilia. Three coproparasitological examinations were positive for cysts of E. nana. The patient was successfully treated with two courses of metronidazole (2 g/day for 10 days each). No antihistamines were used. Three coproparasitological examinations, carried out at the end of the therapy, were negative. Follow up (six months) was negative. E. nana can be responsible for very rare cases of abdominal pain, diarrhoea, polyarthritis and urticaria.
Topics: Abdominal Pain; Adult; Antiprotozoal Agents; Dysentery, Amebic; Endolimax; Feces; Female; Humans; Italy; Metronidazole; Travel; Urticaria
PubMed: 32235095
DOI: 10.3855/jidc.12389 -
BMC Women's Health May 2023Bacterial vaginosis is a common and distressing condition for women. Short-term antibiotic treatment is usually clinically effective, but recurrence is common. We... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Bacterial vaginosis is a common and distressing condition for women. Short-term antibiotic treatment is usually clinically effective, but recurrence is common. We assessed the effectiveness of intravaginal lactic acid gel versus oral metronidazole for treating recurrent bacterial vaginosis.
METHODS
We undertook an open-label, multicentre, parallel group, randomised controlled trial in nineteen UK sexual health clinics and a university health centre. Women aged ≥ 16 years, with current bacterial vaginosis symptoms and a preceding history of bacterial vaginosis, were randomised in a 1:1 ratio using a web-based minimisation algorithm, to 400 mg twice daily oral metronidazole tablets or 5 ml once daily intravaginal lactic acid gel, for 7 days. Masking of participants was not possible. The primary outcome was participant-reported resolution of symptoms within 2 weeks. Secondary outcomes included time to first recurrence of symptoms, number of recurrences and repeat treatments over 6 months and side effects.
RESULTS
Five hundred and eighteen participants were randomised before the trial was advised to stop recruiting by the Data Monitoring Committee. Primary outcome data were available for 79% (204/259) allocated to metronidazole and 79% (205/259) allocated to lactic acid gel. Resolution of bacterial vaginosis symptoms within 2 weeks was reported in 70% (143/204) receiving metronidazole versus 47% (97/205) receiving lactic acid gel (adjusted risk difference -23·2%; 95% confidence interval -32.3 to -14·0%). In those participants who had initial resolution and for whom 6 month data were available, 51 of 72 (71%) women in the metronidazole group and 32 of 46 women (70%) in the lactic acid gel group had recurrence of symptoms, with median times to first recurrence of 92 and 126 days, respectively. Reported side effects were more common following metronidazole than lactic acid gel (nausea 32% vs. 8%; taste changes 18% vs. 1%; diarrhoea 20% vs. 6%, respectively).
CONCLUSIONS
Metronidazole was more effective than lactic acid gel for short-term resolution of bacterial vaginosis symptoms, but recurrence is common following both treatments. Lactic acid gel was associated with fewer reported side effects.
TRIAL REGISTRATION
ISRCTN14161293 , prospectively registered on 18 September 2017.
Topics: Humans; Female; Male; Metronidazole; Vaginosis, Bacterial; Drug-Related Side Effects and Adverse Reactions; Ambulatory Care Facilities; Lactic Acid
PubMed: 37161454
DOI: 10.1186/s12905-023-02303-5 -
The Turkish Journal of Gastroenterology... Apr 2023The purpose of this study was to determine the antimicrobial status of stocked clinical Helicobacter pylori isolates by using antibiotic gradient test and subsequently...
BACKGROUND
The purpose of this study was to determine the antimicrobial status of stocked clinical Helicobacter pylori isolates by using antibiotic gradient test and subsequently identify the mutations that cause clarithromycin resistance by DNA sequencing. Turkey is a transition zone between Europe and Asia; therefore, we also aimed to show both continents' mutations in Turkish isolates.
METHODS
One hundred forty-seven H. pylori isolates that had been stocked at -80°C between 1998 and 2008 were randomly selected and included in the study. Antibiotic susceptibility tests were performed using antibiotic gradient test for clarithromycin, amoxicillin, tetracycline, metronidazole, and levofloxacin. A polymerase chain reaction targeting the region of 23S rRNA gene domain V of H. pylori was performed and the mutations responsible for resistance against clarithromycin were defined by sequencing.
RESULTS
All of the tested isolates were found susceptible to amoxicillin and tetracycline. However, clarithromycin, metronidazole, and levofloxacin resistance were detected in 28.5% (42/147), 44.8% (66/147), and 23.1% (34/147) of the isolates, respectively. Point mutations were detected in 46 isolates (46/147, 31.2%). The majority of mutations were defined as A2143G (19/46, 41.3%), A2142G (14/46, 30.4%), and A2142C (7/46, 15.2%), respectively. T2188C, T2182C, G1949A, G1940A, and C1944T mutations were also identified in the isolates.
CONCLUSION
In conclusion, the most common mutations associated with clarithromycin resistance in H. pylori have been identified as A2143G, A2142G, and A2142C which are the most frequently detected mutations in European countries. Same mutations and other mutations like T2182C have also been detected frequently in north-eastern countries and China. Since Turkey is a transition zone between Europe and Asia, Turkey might have strains that carry mutations found in both continents.
Topics: Humans; Clarithromycin; Helicobacter pylori; Metronidazole; Levofloxacin; Helicobacter Infections; Drug Resistance, Bacterial; Anti-Bacterial Agents; Amoxicillin; Tetracycline; RNA, Ribosomal, 23S; Microbial Sensitivity Tests
PubMed: 36789980
DOI: 10.5152/tjg.2023.21954 -
Journal of Primary Care & Community... 2024Clostridioides difficile infection (CDI) is one of the most common and severe nosocomial infections worldwide. It can also affect healthy individuals in the community.... (Review)
Review
Clostridioides difficile infection (CDI) is one of the most common and severe nosocomial infections worldwide. It can also affect healthy individuals in the community. The incidence of CDI has been on the rise globally for the past decade, necessitating a proactive approach to combat its spread; new strategies are being developed to enhance diagnostic accuracy and optimize treatment outcomes. Implementing the 2-step testing has increased diagnostic specificity, reducing the usage of CD-specific antibiotics with no concomitant increase in surgical complication rates. In 2021, the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America (IDSA/SHEA) shifted its preference for initial treatment to fidaxomicin over vancomycin and metronidazole due to its lower recurrence rate. It also prioritized fidaxomicin for the treatment of recurrent CDI. There are new developments on the frontiers of fecal microbiota therapies, with RBX2660 and SER-109 approved recently by the FDA for prevention, with other microbiome-based therapies in various development and clinical trials. This review offers providers an updated and practical guide for CDI management.
Topics: Humans; Clostridium Infections; Anti-Bacterial Agents; Clostridioides difficile; Fecal Microbiota Transplantation; Cross Infection; Practice Guidelines as Topic; Fidaxomicin; Metronidazole
PubMed: 38726585
DOI: 10.1177/21501319241249645 -
Microbiology Spectrum Aug 2022Clostridioides difficile is one of the most important human pathogens. The identification of its possible sources is important for the understanding of C. difficile...
Clostridioides difficile is one of the most important human pathogens. The identification of its possible sources is important for the understanding of C. difficile infection (CDI) epidemiology. A total of 16 water samples from wastewater and surface water in South Moravia in the Czech Republic and 82 samples of fish and gulls were collected between May and July 2019. C. difficile isolates were cultured by direct plating and after enrichment on chromogenic media. Susceptibility testing to eight antimicrobials was performed by Etest. C. difficile isolates were characterized by ribotyping, multilocus sequence typing, multilocus tandem repeats analysis, and toxin gene detection. Samples from fish and gulls were C. difficile negative; a total of 15 C. difficile isolates from 8 out of 16 water samples were cultured (6 out of 14 surface water samples yielded 6 isolates, and 2 out of 2 wastewater samples yielded 9 isolates). Direct plating was culture positive in 6 out of 16 samples (12 isolates), and enrichment culture was positive in an additional 2 out of 16 samples (3 isolates). Twelve different ribotyping profiles and 14 sequence types of clades 1, 4, and 5 were identified. Five isolates did not carry genes for toxins, and eight isolates carried genes for toxins A and B; the remaining two isolates (RT078) carried the genes for toxins A, B, and binary. All C. difficile isolates were susceptible to amoxicillin, moxifloxacin, tetracycline, and vancomycin and resistant to ciprofloxacin. A high level of erythromycin resistance (>256 mg/L) was detected in eight isolates. Clindamycin resistance was found in 14 isolates, 6 of which showed a high level of resistance (>256 mg/L) and carried . Surprisingly, one isolate (RT010, ST15) showed resistance to metronidazole (12 mg/L) with the presence of the plasmid pCD-METRO. In conclusion, a diverse spectrum of C. difficile strains was found in wastewater and surface water. A recently discovered plasmid-bound resistance to metronidazole was detected in C. difficile from the surface water sample. The combination of direct plating and culture after enrichment was used in order to gain a spectrum of C. difficile ribotypes present in the water samples. Toxigenic C. difficile ribotypes detected in surface water and in wastewater treatment plants overlapped with those derived from patients with CDI and/or animals. Importantly, a recently discovered plasmid-mediated resistance to metronidazole, a drug used for the treatment of CDI, was detected in C. difficile from river water.
Topics: Animals; Anti-Bacterial Agents; Clostridioides; Clostridioides difficile; Clostridium Infections; Drug Resistance, Bacterial; Humans; Metronidazole; Microbial Sensitivity Tests; Plasmids; Rivers; Wastewater; Water
PubMed: 35950844
DOI: 10.1128/spectrum.00806-22 -
The Journal of Dermatology Mar 2022Topical metronidazole is not currently approved in Japan as a treatment for the indication of rosacea, although 0.75% metronidazole gel was authorized in 2014 for the... (Randomized Controlled Trial)
Randomized Controlled Trial
Topical metronidazole is not currently approved in Japan as a treatment for the indication of rosacea, although 0.75% metronidazole gel was authorized in 2014 for the management of cancerous skin ulcers. We conducted a randomized, double-blind, vehicle-controlled study to evaluate the efficacy and safety of 0.75% metronidazole gel in Japanese patients with inflammatory lesions (papules/pustules) and erythema associated with moderate to severe rosacea. Overall, 130 patients were randomly assigned to receive 0.75% metronidazole gel (n = 65) or vehicle (n = 65), and 120 patients completed 12 weeks of treatment. The primary efficacy outcome was the proportion of patients who achieved both of the following at week 12: an improvement of >50% in the number of inflammatory lesions (papules/pustules) and a positive change of at least one degree in erythema severity. This composite outcome was achieved by 72.3% of metronidazole-treated patients versus 36.9% of vehicle-treated patients, with the between-group difference demonstrating significant improvement with 0.75% metronidazole gel (p < 0.0001). All secondary efficacy endpoints (patients achieving a score of ≥3 for percent change in the number of inflammatory lesions at week 12; patients achieving a score of ≥3 for change in erythema severity at week 12; patients achieving an Investigator's Global Assessment score of 0 or 1 at week 12; percent change over time in the number of inflammatory lesions; change over time in erythema severity) also showed improvement in the 0.75% metronidazole gel group. The incidence of adverse events was higher with metronidazole (40.0%) than with vehicle (29.2%). Of these, treatment-related, treatment-emergent adverse events occurred in 9.2% and 6.2% in the metronidazole and the vehicle group, respectively, but there were no new safety concerns. Overall, the results of this study have confirmed the efficacy and safety of 0.75% metronidazole gel in Japanese patients with rosacea.
Topics: Dermatologic Agents; Double-Blind Method; Humans; Japan; Metronidazole; Rosacea; Treatment Outcome
PubMed: 34854112
DOI: 10.1111/1346-8138.16254 -
BMC Oral Health May 2021Treating periodontitis through non-surgical periodontal therapy (NSPT) may improve glycemic control in type-2 Diabetes Mellitus (T2DM) patients. However, the evidence to... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Treating periodontitis through non-surgical periodontal therapy (NSPT) may improve glycemic control in type-2 Diabetes Mellitus (T2DM) patients. However, the evidence to maintain this improvement beyond four months is insufficient. Hence, this trial was conducted to assess clinical efficacy of NSPT on glycemic control in T2DM patients.
METHODS
This three-arm randomized controlled trial recruited 150 known T2DM participants (35-65 years), suffering from moderate to severe periodontitis, having HbA1c level ≥ 6.5% at baseline. Participants were followed up at 3 and 6 months. Intervention for test group-1 included scaling and root planing (SRP) with metronidazole (MET) and oral hygiene instructions (OHI). Test group-2 was intervened with SRP + OHI and control group with OHI only. Stata v. 14 was used to observe inter and intragroup mean changes in glycemic [glycated hemoglobin (HbA1c), fasting blood glucose (FBG)] and periodontal variables [bleeding on probing (BOP), periodontal pocket depth (PPD), clinical attachment loss (CAL)] using ANOVA and RMANOVA. Proportion of change in outcome variable (HbA1c) was assessed between treatment groups using chi-square test. Change was considered significant at p-value ≤ 0.05.
RESULTS
A significant reduction was observed in BOP, PPD, CAL, HbA1c and FBG over time [p < 0.05]. Significant reductions were observed in same variables in both test groups in comparison to control arm [p < 0.05]. No change between the two test groups was observed [p > 0.05].
CONCLUSION
Scaling and root planing improves glycemic control of T2DM patients independently of the use of MET. Therefore, SRP after every 6 months may be suggested and included as a part of overall diabetes management for patients suffering from T2DM. Clinical trial registration NCT 03,343,366 [Date of Registration: 17/11/2017].
Topics: Blood Glucose; Chronic Periodontitis; Dental Scaling; Humans; Metronidazole; Periodontal Attachment Loss; Root Planing; Treatment Outcome
PubMed: 33980234
DOI: 10.1186/s12903-021-01620-1 -
Journal of Korean Medical Science Sep 2023The lack of well-established operational definitions is a major limitation of eradication studies that use secondary databases. We aimed to develop and validate...
BACKGROUND
The lack of well-established operational definitions is a major limitation of eradication studies that use secondary databases. We aimed to develop and validate operational definitions related to eradication therapy.
METHODS
Operational definitions were developed by analyzing a nationwide eradication registry and validated using real-world data from hospital medical records. The primary endpoint was the sensitivity of the operational definitions in identifying individuals who received eradication therapy. The secondary endpoint was the sensitivity and specificity of the operational definition in identifying successful eradication therapy.
RESULTS
eradication therapy was defined as a prescription for one of the following combinations: 1) proton pump inhibitor (PPI) + amoxicillin + clarithromycin, 2) PPI + amoxicillin + metronidazole, 3) PPI + metronidazole + tetracycline, 4) PPI + amoxicillin + levofloxacin, 5) PPI + amoxicillin + moxifloxacin, or 6) PPI + amoxicillin + rifabutin. In the validation set, the sensitivity of the operational definition for identifying individuals who received eradication therapy was 99.7% and 99.8% for the first- and second-line therapies, respectively. Operational definition to determine success or failure of the eradication therapy was developed based on a confirmatory test and the prescription of rescue therapy. The sensitivity and specificity of the operational definition for predicting successful eradication were 97.6% and 91.4%, respectively, in first-line therapy and 98.6% and 54.8%, respectively, in second-line therapy.
CONCLUSION
We developed and validated operational definitions related to eradication therapy. These definitions will help researchers perform various eradication-related studies using secondary databases.
Topics: Humans; Helicobacter pylori; Metronidazole; Research Design; Anti-Bacterial Agents; Amoxicillin; Proton Pump Inhibitors
PubMed: 37667583
DOI: 10.3346/jkms.2023.38.e278