scholarly journals Doxycycline is a safe alternative to Hydroxychloroquine + Azithromycin to prevent clinical worsening and hospitalization in mild COVID-19 patients: An open label randomized clinical trial (DOXYCOV)

2021 ◽  
Author(s):  
Eugene Sobngwi ◽  
Sylvain Zemsi ◽  
Magellan Guewo-Fokeng ◽  
Jean Claude Katte ◽  
Charles Kouanfack ◽  
...  
Keyword(s):  
Clinical Cure ◽  
Primary Outcome ◽  
Clinical Cure Rate ◽  
Treatment Initiation ◽  
National Standard ◽  
Cure Rate ◽  
Open Label ◽  
Safe Alternative ◽  
Percentage Points ◽  
Clinical Worsening

Objective: We aimed to compare the safety and efficacy of a doxycycline-based regimen against the national standard guidelines (Hydroxychloroquine plus Azithromycin) for the treatment of mild symptomatic COVID-19. Methods: We conducted an open-label, randomized, non-inferiority trial, in Cameroon comparing Doxycycline 100mg, twice daily for 7 days versus Hydroxychloroquine, 400 mg daily for 5 days and Azithromycin 500mg at day 1 and 250mg from day 2 through 5, in mild COVID-19 patients. Clinical improvement, biological parameters and adverse events were assessed. The primary outcome was the proportion of clinical cure at day 3, 10 and 30. Non-inferiority was determined by the clinical cure rate between protocols with a 20 percentage points margin. Results: 194 participants underwent randomization and were treated with Doxycycline (n=97) or Hydroxychloroquine-Azithromycin (n=97). At day 3, 74/92 (80.4%) participants on Doxycycline versus 77/95 (81.1%) on Hydroxychloroquine-Azithromycin -based protocols were asymptomatic (p=0.91). At day 10, 88/92 (95.7%) participants on Doxycycline versus 93/95 (97.9%) on Hydroxychloroquine-Azithromycin were asymptomatic (p=0.44). At day 30 all participants were asymptomatic. SARS-CoV2 PCR was negative at Day 10 in 60/92 (65.2%) participants allocated to Doxycycline and 63/95 (66.3%) participants allocated to Hydroxychloroquine-Azithromycin. None of the participants were admitted for worsening of the disease after treatment initiation. Conclusion: Doxycycline 100 mg twice daily for 7 days is as effective and safe as Hydroxychloroquine-Azithromycin, for preventing clinical worsening of mild symptomatic or asymptomatic COVID-19, and achieving virological suppression

scholarly journals 1692. Retrospective Review on the Safety and Efficacy of Nitrofurantoin for the Treatment of Cystitis in the Veteran Population With or Without Renal Insufficiency

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S829-S830
Author(s):  
Elwyn W Welch ◽  
Shaila Sheth ◽  
Chester Ashong ◽  
Caroline Pham
Keyword(s):  
Renal Function ◽  
Renal Dysfunction ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Retrospective Chart Review ◽  
Outpatient Setting ◽  
Secondary Outcome ◽  
Cure Rate ◽  
Acute Cystitis ◽  
Significant Difference

Abstract Background Nitrofurantoin has been used to treat cystitis in women; however, data supporting its use in men is lacking. In addition, recent retrospective studies have challenged the manufacturer’s recommendation to avoid nitrofurantoin with creatinine clearances (CrCl) less than 60 mL/min. The purpose of this study is to compare the efficacy and safety of nitrofurantoin for the treatment of acute cystitis in male and female veterans with variable degrees of renal dysfunction. Methods A retrospective chart review was conducted in adult patients who received nitrofurantoin for acute cystitis in the outpatient setting between May 1, 2018 and May 1, 2019. The primary outcomes were rates of clinical cure as compared between males and females, and across various renal function groups (CrCl greater than 60 mL/min, 30 to 60 mL/min, and less than 30 mL/min) following treatment with nitrofurantoin. The secondary outcome was adverse event rates. Results A total of 446 patients were included with 278 females and 168 males. Overall clinical cure rate was 86.5% (n=386). Clinical cure rate did not vary between genders (p=0.0851) or CrCl ranges (p=1.0) as shown in the tables. Benign prostatic hyperplasia (BPH) was associated with decreased odds of clinical cure (OR 0.50 [95% CI 0.26-0.97], p=0.0404) in addition to cirrhosis (OR 0.22 [95% CI 0.06-0.91], p=0.0357). Adverse events occurred in 2% of patients and did not vary based on gender or renal function. RATES OF CLINICAL CURE Conclusion There was no statistically significant difference in clinical cure with nitrofurantoin between genders and various renal impairments. However, history of BPH and cirrhosis were associated with decreased efficacy. Subgroup analysis also revealed lower efficacy in males with CrCl greater than 60 mL/min versus females with similar renal function. This study adds to the growing body of literature suggesting that renal dysfunction with CrCl of 30 to 60 mL/min may not carry the risk of treatment failure and adverse effects previously associated with nitrofurantoin, but large randomized trials are needed to confirm these results. Disclosures All Authors: No reported disclosures

scholarly journals Phase 2 Study of Ceftaroline versus Standard Therapy in Treatment of Complicated Skin and Skin Structure Infections

2007 ◽  
Vol 51 (10) ◽  
pp. 3612-3616 ◽  
Author(s):  
George H. Talbot ◽  
Dirk Thye ◽  
Anita Das ◽  
Yigong Ge
Keyword(s):  
Success Rate ◽  
Standard Therapy ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Tolerability Profile ◽  
Clinical Relapse ◽  
Cure Rate ◽  
Ceftaroline Fosamil ◽  
Skin Structure ◽  
Complicated Skin

ABSTRACT Ceftaroline, the bioactive metabolite of ceftaroline fosamil (previously PPI-0903, TAK-599), is a broad-spectrum cephalosporin with potent in vitro activity against multidrug-resistant gram-positive aerobic pathogens, including methicillin-resistant Staphylococcus aureus. A randomized, observer-blinded study to evaluate the safety and efficacy of ceftaroline versus standard therapy in treating complicated skin and skin structure infections (cSSSI) was performed. Adults with cSSSI, including at least one systemic marker of inflammation, were randomized (2:1) to receive intravenous (i.v.) ceftaroline (600 mg every 12 h) or i.v. vancomycin (1 g every 12 h) with or without adjunctive i.v. aztreonam (1 g every 8 h) for 7 to 14 days. The primary outcome measure was the clinical cure rate at a test-of-cure (TOC) visit 8 to 14 days after treatment. Secondary outcomes included the microbiological success rate (eradication or presumed eradication) at TOC and the clinical relapse rate 21 to 28 days following treatment. Of 100 subjects enrolled, 88 were clinically evaluable; the clinical cure rate was 96.7% (59/61) for ceftaroline versus 88.9% (24/27) for standard therapy. Among the microbiologically evaluable subjects (i.e., clinically evaluable and having had at least one susceptible pathogen isolated at baseline), the microbiological success rate was 95.2% (40/42) for ceftaroline versus 85.7% (18/21) for standard therapy. Relapse occurred in one subject in each group (ceftaroline, 1.8%; standard therapy, 4.3%). Ceftaroline exhibited a very favorable safety and tolerability profile, consistent with that of marketed cephalosporins. Most adverse events from ceftaroline were mild and not related to treatment. Ceftaroline holds promise as a new therapy for treatment of cSSSI and other serious polymicrobial infections.

scholarly journals Impact of Colistin Dosing on the Incidence of Nephrotoxicity in a Tertiary Care Hospital in Saudi Arabia

Antibiotics ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. 485 ◽  
Author(s):  
Reem Almutairy ◽  
Waad Aljrarri ◽  
Afnan Noor ◽  
Pansy Elsamadisi ◽  
Nour Shamas ◽  
...  
Keyword(s):  
Serum Albumin ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Serum Albumin Level ◽  
Tertiary Care ◽  
Multivariable Analysis ◽  
Severity Of Illness ◽  
Albumin Level ◽  
Care Hospital ◽  
Cure Rate

Colistin therapy is associated with the development of nephrotoxicity. We examined the incidence and risk factors of nephrotoxicity associated with colistin dosing. We included adult hospitalized patients who received intravenous (IV) colistin for >72 h between January 2014 and December 2015. The primary endpoint was the incidence of colistin-associated acute kidney injury (AKI). The secondary analyses were predictors of nephrotoxicity, proportions of patients inappropriately dosed with colistin according to the Food and Drug Administration (FDA), European Medicines Agency (EMA), and Garonzik formula and clinical cure rate. We enrolled 198 patients with a mean age of 55.67 ± 19.35 years, 62% were men, and 60% were infected with multidrug-resistant organisms. AKI occurred in 44.4% (95% CI: 37.4–51.7). Multivariable analysis demonstrated that daily colistin dose per body weight (kg) was associated with AKI (OR: 1.57, 95% CI: 1.08–2.30; p = 0.02). Other significant predictors included serum albumin level, body mass index (BMI), and severity of illness. None of the patients received loading doses, however FDA-recommended dosing was achieved in 70.2% and the clinical cure rate was 13%. The incidence of colistin-associated AKI is high. Daily colistin dose, BMI, serum albumin level, and severity of illness are independent predictors of nephrotoxicity.

scholarly journals The Efficacy and Safety of Eravacycline in the Treatment of Complicated Intra-Abdominal Infections: A Systemic Review and Meta-Analysis of Randomized Controlled Trials

2019 ◽  
Vol 8 (6) ◽  
pp. 866 ◽  
Author(s):  
Shao-Huan Lan ◽  
Shen-Peng Chang ◽  
Chih-Cheng Lai ◽  
Li-Chin Lu ◽  
Chien-Ming Chao
Keyword(s):  
Adverse Event ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Clinical Failure ◽  
Efficacy And Safety ◽  
Cure Rate ◽  
Randomized Controlled ◽  
Evaluable Population ◽  
Intent To Treat ◽  
Treat Population

This study aims to assess the clinical efficacy and safety of eravacycline for treating complicated intra-abdominal infection (cIAI) in adult patients. The PubMed, Web of Science, EBSCO, Cochrane databases, Ovid Medline, Embase, and ClinicalTrials.gov were searched up to May 2019. Only randomized controlled trials (RCTs) that evaluated eravacycline and other comparators for the treatment of cIAI were included. The primary outcome was the clinical cure rate at the test-of-cure visit based on modified intent-to-treat population, microbiological intent-to-treat population, clinically evaluable population, and microbiological evaluable population, and the secondary outcomes were clinical failure rate and the risk of adverse event. Three RCTs were included. Overall, eravacycline had a clinical cure rate (88.7%, 559/630) at test-of-cure in modified intent-to-treat population similar to comparators (90.1%, 492/546) in the treatment of cIAIs (risk ratio (RR), 0.99; 95% confidence interval (CI), 0.95–1.03; I2 = 0%, Figure 3). In the microbiological intent-to-treat, clinically evaluable, and microbiological evaluable populations, no difference was found between eravacycline and comparators in terms of clinical cure rate at test-of-cure (microbiological intent-to-treat population, RR, 0.99; 95% CI, 0.95–1.04; I2 = 0%, clinically evaluable population, RR, 1.00; 95% CI, 0.97–1.03; I2 = 0%, microbiological evaluable population, RR, 0.98; 95% CI, 0.95–1.02; I2 = 0%). In addition, eravacycline had clinical failure rate similar to comparators at test-of-cure in modified intent-to-treat population (RR, 1.01; 95% CI, 0.61–0.69; I2 = 0%), microbiological intent-to-treat population (RR, 1.34; 95% CI, 0.77–2.31; I2 = 16%), clinically evaluable population (RR, 1.03; 95% CI, 0.61–1.76; I2 = 0%), and microbiological evaluable population (RR, 1.32; 95% CI, 0.75–2.32; I2 = 10%). Although eravacycline was associated with higher risk of treatment-emergent adverse event than comparators (RR, 1.34; 95% CI, 1.13–1.58; I2 = 0%), no significant differences were found between eravacycline and comparators for the risk of serious adverse event (RR, 1.04; 95% CI, 0.65–1.65; I2 = 0%), discontinuation of study drug because of adverse event (RR, 0.68; 95% CI, 0.23–1.99; I2 = 13%), and all-cause mortality (RR, 1.09; 95% CI, 0.41–2.9; I2 = 28%). In conclusion, the clinical efficacy of eravacycline is as high as that of the comparator drugs in the treatment of cIAIs and this antibiotic is as well tolerated as the comparators.

scholarly journals Ceftazidime–Avibactam versus Meropenem for the Treatment of Complicated Intra-Abdominal Infections

Antibiotics ◽  
2019 ◽  
Vol 8 (4) ◽  
pp. 255 ◽  
Author(s):  
Che-Kim Tan ◽  
Chih-Cheng Lai ◽  
Chien-Ming Chao
Keyword(s):  
Adverse Events ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Study Drug ◽  
Comparable Efficacy ◽  
Integrated Analysis ◽  
Cure Rate ◽  
Serious Adverse Events ◽  
Mitt Population ◽  
Abdominal Infections

This study reports an integrated analysis of three randomized controlled trials to compare the clinical efficacies and safety of the ceftazidime–avibactam (CAZ–AVI) combination and meropenem in the treatment of adult patients with complicated intra-abdominal infections (cIAIs). Overall, a total of 1677 patients (CAZ–AVI: 835 patients; meropenem: 842 patients) were included in this analysis. CAZ–AVI had a clinical cure rate at test of cure in the clinically evaluable (CE) population similar to that of meropenem (OR, 0.88; 95% CI, 0.58–1.32; I2 = 0%). Similar trends were also observed in the modified intent-to-treat (MITT) population (OR, 0.80; 95% CI, 0.59–1.09; I2 = 0%) and microbiological evaluable (ME) population (OR, 0.73; 95% CI, 0.32–1.68; I2 = 0%). In terms of clinical cure rate at the end of treatment, the efficacy of CAZ–AVI was comparable to that of meropenem in the CE population (OR, 0.77; 95% CI, 0.47–1.25; I2 = 0%), MITT population (OR, 0.70; 95% CI, 0.47–1.06; I2 = 5%), and ME population (OR, 1.26; 95% CI, 0.39–4.08; I2 = 0%). CAZ–AVI had a similar risk of (i) treatment emergent adverse events (TEAEs) (OR, 1.03; 95% CI, 0.79–1.36; I2 = 38%), (ii) any serious adverse events (OR, 0.97; 95% CI, 0.67–1.40; I2 = 0%), (iii) discontinuation of study drug due to TEAE (OR, 2.14; 95% CI, 1.00–4.57), and iv) all-cause mortality (OR, 1.66; 95% CI, 0.78–3.53; I2 = 0%) when compared with meropenem. In conclusion, CAZ–AVI had comparable efficacy and safety profile to those of meropenem in the treatment of cIAI.

scholarly journals Cethromycin versus Clarithromycin for Community-Acquired Pneumonia: Comparative Efficacy and Safety Outcomes from Two Double-Blinded, Randomized, Parallel-Group, Multicenter, Multinational Noninferiority Studies

2012 ◽  
Vol 56 (4) ◽  
pp. 2037-2047 ◽  
Author(s):  
Marci L. English ◽  
Christine E. Fredericks ◽  
Nancy A. Milanesio ◽  
Nestor Rohowsky ◽  
Ze-Qi Xu ◽  
...  
Keyword(s):  
Clinical Cure ◽  
Clinical Cure Rate ◽  
The United States ◽  
Community Acquired Pneumonia ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Cure Rate ◽  
Content Type ◽  
Dosing Regimens ◽  
Double Blinded

ABSTRACTCommunity-acquired pneumonia (CAP) continues to be a major health challenge in the United States and globally. Factors such as overprescribing of antibiotics and noncompliance with dosing regimens have added to the growing antibacterial resistance problem. In addition, several agents available for the treatment of CAP have been associated with serious side effects. Cethromycin is a new ketolide antibiotic that may provide prescribing physicians with an additional agent to supplement a continually limited armamentarium. Two global phase III noninferiority studies (CL05-001 and CL06-001) to evaluate cethromycin safety and efficacy were designed and conducted in patients with mild to moderate CAP. Study CL05-001 demonstrated an 83.1% clinical cure rate in the cethromycin group compared with 81.1% in the clarithromycin group (95% confidence interval [CI], −4.8%, +8.9%) in the intent to treat (ITT) population and a 94.0% cethromycin clinical cure rate compared with a 93.8% clarithromycin cure rate (95% CI, −4.5%, +5.1%) in the per protocol clinical (PPc) population. Study CL06-001 achieved an 82.9% cethromycin clinical cure rate in the ITT population compared with an 88.5% clarithromycin cure rate (95% CI, −11.9%, +0.6%), whereas the clinical cure rate in the PPc population was 91.5% in cethromycin group compared with 95.9% in clarithromycin group (95% CI, −9.1%, +0.3%). Both studies met the primary endpoints for clinical cure rate based on predefined, sliding-scale noninferiority design. Therefore, in comparison with clarithromycin, these two noninferiority studies demonstrated the efficacy and safety of cethromycin, with encouraging findings of efficacy in subjects withStreptococcus pneumoniaebacteremia. No clinically significant adverse events were observed during the studies. Cethromycin may be a potential oral therapy for the outpatient treatment of CAP.

scholarly journals Prospective Study of the Wilson Severity-of-Illness Scoring System for Complicated Skin and Skin Structure Infections

2012 ◽  
Vol 57 (1) ◽  
pp. 647-650 ◽  
Author(s):  
George H. Talbot ◽  
Tanya O'Neal ◽  
Anita F. Das ◽  
Dirk Thye
Keyword(s):  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Severity Of Illness ◽  
Cure Rate ◽  
Two Phase ◽  
Ceftaroline Fosamil ◽  
Risk Class ◽  
Skin Structure ◽  
Complicated Skin ◽  
Cure Rates

ABSTRACTWilson et al. (Am. J. Surg.185:369–375, 2003) developed a disease severity classification system for use in complicated skin and skin structure infections (cSSSI). Two phase 3 trials of ceftaroline fosamil in cSSSI provided the opportunity to evaluate the association between Wilson Severity Risk Class and clinical cure rates. Our analyses did not confirm that an association exists between Wilson Severity Risk Class and clinical cure rate and, thus, did not validate its predictive utility.

scholarly journals Comparing Several Treatments with Antibiotics for CommunityAcquired Pneumonia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Author(s):  
Fusheng Bai ◽  
Xinming Li
Keyword(s):  
Randomized Controlled Trials ◽  
Subgroup Analysis ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Clinical Effects ◽  
Cure Rate ◽  
Ceftaroline Fosamil ◽  
Randomized Controlled

Background: We aimed to review relevant randomized controlled trials to assess the relative clinical effects of antibiotic treatment of patients with community-acquired pneumonia (CAP). Methods: In this meta-analysis, we identified relevant studies from PubMed, Cochrane, and Embase using appropriate keywords. Key pertinent sources in the literature were also reviewed and all articles published through Oct 2019 were considered for inclusion. For each study, we assessed the risk ratios (RRs) or mean difference combined with the 95% confidence interval (CI) to assess and synthesize outcomes. Results: Overall, 36 studies were consistent with the meta-analysis, involving 17,076 patients. There was no significant difference in the mortality after subgroup analysis: individualized treatment vs. standard treatment; β-lactams plus macrolides vs. β-lactam and/or fluoroquinolone; ceftaroline fosamil vs. ceftriaxone; combination therapy vs. monotherapy or high-dose vs. low-dose. The drug-related adverse event incidence was significantly higher in the ceftriaxone group than in the other drug groups (P<0.05) and also higher in the tigecyline group than in the levofloxacin group (P<0.05). Compared with ceftriaxone, ceftaroline fosamil significantly increased the clinical cure rate at the test-of-cure (TOC) visit in the clinically evaluable population, modified intent-to-treat efficacy (MITTE) population, microbiologically evaluable (ME) population and the microbiological MITTE (mMITTE) population (all P<0.05). Compared with ceftriaxone, ceftaroline fosamil significantly increased the clinical cure rate at the TOC visit in the mMITTE population of Gram positiveStreptococcus pneumoniae (P<0.05) and multidrug-resistant S. pneumoniae (P<0.05). Conclusion: There was a limited number of included studies in the subgroup analysis, but it will still be necessary to conduct more high-quality randomized controlled trials to confirm the clinical efficacy of different antibiotics used to treat CAP.

scholarly journals Ceftaroline Efficacy and Safety in Treatment of Complicated Skin and Soft Tissue Infection: A Systemic Review and Meta-Analysis of Randomized Controlled Trials

2019 ◽  
Vol 8 (6) ◽  
pp. 776 ◽  
Author(s):  
Shao-Huan Lan ◽  
Shen-Peng Chang ◽  
Chih-Cheng Lai ◽  
Li-Chin Lu ◽  
Chien-Ming Chao
Keyword(s):  
Randomized Controlled Trials ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Meta Analysis ◽  
Adult Patients ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Cure Rate ◽  
Randomized Controlled ◽  
Complicated Skin

This study aims to assess the clinical efficacy and safety of ceftaroline for the treatment of complicated skin and skin structure infections (cSSSIs) in adult patients through meta-analysis. PubMed, Embase, ClinicalTrials.gov, and Cochrane databases were searched up to April 2019. Only randomized controlled trials (RCTs) that evaluated ceftaroline and other comparators for treating cSSSIs in adult patients were included. The primary outcome was the clinical cure rate, whereas the secondary outcomes were clinical failure rate, microbiological eradication rate, relapse rate, and risk of an adverse event (AE). Five RCTs were included. Overall, ceftaroline had a clinical cure rate similar to comparators in the treatment of cSSSIs in the modified intent-to-treat population (risk ratio (RR), 1.00; 95% confidence interval (CI), 0.97–1.04; I2 = 0%) and in the clinically evaluable population (RR, 1.00; 95% CI, 0.97–1.03; I2 = 0%). In addition, no significant difference was observed between ceftaroline and comparators for the treatment of infection with Staphylococcus aureus (RR, 1.01; 95% CI, 0.98–1.05; I2 = 0%), methicillin-resistant S. aureus (RR, 0.99; 95% CI, 0.94–1.05; I2 = 0%), methicillin-susceptible S. aureus (RR, 1.01; 95% CI, 0.96–1.06; I2 = 26%), Streptococcus spp. (RR, 1.07; 95% CI, 0.92–1.24; I2 = 73%), and Gram-negative bacteria (RR, 0.94; 95% CI, 0.83–1.08; I2 = 0%). Furthermore, ceftaroline had a similar rate of microbiological eradication (92.2% vs. 92.6%, RR, 1.00; 95% CI, 0.97–1.03; I2 = 9%) and relapse (6.9% vs. 9.1%, RR, 0.48; 95% CI, 0.14–1.74; I2 = 0%) as comparators. Finally, the risks of treatment-emergent AEs (RR, 0.96; 95% CI, 0.88–1.05; I2 = 0%), serious AEs (RR, 1.03; 95% CI, 0.63–1.68; I2 = 0%), and discontinuation of study drug due to an AE (RR, 0.86; 95% CI, 0.50–1.49; I2 = 34%) did not differ significantly between ceftaroline and comparators. In conclusion, the clinical efficacy of ceftaroline is as high as that of comparators in the treatment of cSSSIs in adult patients, and this antibiotic is well tolerated like the comparators.

scholarly journals Efficacy of Propolis on the Denture Stomatitis Treatment in Older Adults: A Multicentric Randomized Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-9 ◽  
Author(s):  
Gisela de M. S. Pina ◽  
Erica N. Lia ◽  
Andresa A. Berretta ◽  
Andresa P. Nascimento ◽  
Elina C. Torres ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Control Group ◽  
Cure Rate ◽  
Denture Stomatitis ◽  
Propolis Extract ◽  
Before And After ◽  
Baseline Characteristics ◽  
Brazilian Propolis

Our hypothesis tested the efficacy and safety of a mucoadhesive oral gel formulation of Brazilian propolis extract compared to miconazole oral gel for the treatment of denture stomatitis due toCandidaspp. infection in older adults. Forty patients were randomly allocated in a noninferiority clinical trial into two groups. The control group (MIC) received 20 mg/g miconazole oral gel and the study group (PROP) received mucoadhesive formulation containing standardized extract of 2% (20 mg/g) propolis (EPP-AF®) during 14 days. Patients were examined on days 1, 7, and 14. The Newton’s score was used to classify the severity of denture stomatitis. The colony forming unity count (CFU/mL) was quantified and identified (CHROMagarCandida®) before and after the treatment. Baseline characteristics did not differ between groups. Both treatments reduced Newton’s score (P<0.0001), indicating a clinical improvement of the symptoms of candidiasis with a clinical cure rate of 70%. The microbiological cure with significant reduction in fungal burden on T14 was 70% in the miconazole group and 25% in the EPP-AF group. The EPP-AF appears to be noninferior to miconazole considering the clinical cure rate and could be recommended as an alternative treatment in older patients.

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