fusafungin and Respiratory-Tract-Infections

Topics: Animals; Anti-Bacterial Agents; Depsipeptides; Fusarium; Humans; Respiratory Tract Infections; Treatment Outcome

Despite guidelines and educational programs, systemic antibiotics and anti-inflammatory drugs are often inappropriately prescribed in upper respiratory tract infections (URTIs), although they are most often of viral origin, generally benign, and self-limiting with spontaneous recovery in more than 80% of cases. Reduced use of systemic antibiotics is crucial in the current context of concern about emerging antibiotic resistance and reducing unnecessary costs associated both with drug over-consumption and with the management of the consequences of antibiotic resistance. Local bacterial or viral infection of the airways induces an early inflammatory reaction. Although this inflammatory reaction has a beneficial effect in the capture and destruction of the pathogens, it can be responsible for deleterious tissue damage and vascular alterations leading to a self-perpetuating cycle of events. A wide array of medicines is available for symptomatic relief of URTIs: many of them are partially effective in reducing symptoms, but none is curative. Local administration of antibiotics and anti-inflammatory drugs allows drug delivery directly to the target site of infection and inflammation, i.e., the respiratory mucosa, thus enabling a higher concentration of the drug, which results in smaller doses to be given, decreased potential for systemic toxicity, fewer side effects, protection of other flora, and rapid relief. Fusafungine is a naturally occurring peptide antibiotic with anti-inflammatory properties, which selectively targets the tissue reaction and preserves the natural antibacterial and antiviral defences. It is indicated for topical use in nose and throat infections. A recent analysis of French general practitioners' (GPs) prescribing pattern in the field of URTIs has demonstrated that prescription of fusafungine has achieved what many educational programs have failed to do: a significant reduction in the 'real life' prescription of systemic antibiotics and antiinflammatory drugs, without the side effects of corticosteroids and vasoconstrictive agents, and without impact on microbial ecology.

Topics: Administration, Topical; Aerosols; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Depsipeptides; Fusarium; Humans; Respiratory Tract Infections

The aim of the study was evaluation of efficacy and safety of new form of fusafungine in the treatment of upper respiratory tract infections in adults. The study comprised 1639 patients treated in 288 centres in Poland. Fusafungine (Bioparox) was administered 4 applications to the pharynx and/or to the nose every 4 hours during the day. The result of treatment were observed after 5 days. Signs and symptoms of infections were observed both by the physician and by the patients. In 1188 patients regression of signs and symptoms was observed after 5 days of treatment both in bacterial and viral infections. Fusafungine in a new (without freon) form is efficacy and safety drugs in the treatment of upper respiratory tract infections in adults.

Topics: Acute Disease; Adult; Aerosols; Anti-Bacterial Agents; Depsipeptides; Diagnosis, Differential; Drug Administration Routes; Female; Fusarium; Humans; Male; Poland; Program Evaluation; Respiratory Tract Infections; Severity of Illness Index

The objective of this study was to assess the effectiveness and acceptability of fusafungine in the treatment of patients with community-acquired, upper respiratory tract infections. These infections, although frequently of viral origin, may be conducive to bacterial superinfection. Fusafungine, a combination of several enniatins, has been shown to display bacteriostatic activity against many micro-organisms responsible for infections of the respiratory tract, along with anti-inflammatory activity. This open, multi-centre study analysed data on 166 patients suffering from upper respiratory tract infections treated for 7 or 10 days with a fusafungine metered-dose spray. The incidence of upper respiratory tract symptoms was significantly reduced from baseline (p < or = 0.001) with the treatment evaluated as excellent or good by 92.1% of physicians. In 77.7% of the patients, no further treatment was necessary at the end of the seven-day therapeutic period. Out of the 37 patients who had the treatment prolonged for three more days, 78.4% had regression of their URTI at the end of therapy. In terms of tolerability, assessment by the investigators and the patients themselves demonstrated that fusafungine was extremely well tolerated. Acceptability of the treatment was considered poor by only one patient. Results of this study suggest that fusafungine, whatever the aetiology of the infection, gives rapid relief of nasal and pharyngeal symptoms and provides strong evidence of its efficacy and acceptability in treating URTIs.

Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Aged; Anti-Bacterial Agents; Depsipeptides; Fusarium; Humans; Middle Aged; Pharynx; Respiratory Tract Infections; Treatment Outcome

As the main target of influenza viral aggression, the respiratory tract is subject to easier bacterial infection superimposition. The researchers from Les Laboratoires Servier--France, managed to isolate a substance--fusafungine--from the microspore of the fungus Fusarium lateritium, which demonstrates unique anti-inflammatory and antibiotic action, and is the active ingredient of Bioparox Spray, an inhalant. The principal indications of Bioparox Spray for treatment of respiratory tract infections fall within the range from the sinuses to the finest alveolar duct, namely: rhinitis, sinusitis, tonsillitis, pharyngitis, laryngitis, tracheitis and bronchitis. In terms of technology Bioparox is unique due to the fact that 90% of the aerosol particles are less than one micron large, while generally the particles needed for penetration through the alveolar duct should be less than three microns. Due to such micronization, after inhalation Bioparox Spray reaches from the sinuses to the finest bronchial branches. Bioparox Spray possesses sound and broad antibiotic spectrum of action on the most common causative agents of respiratory infections, and more over, it acts upon Candida albicans, unlike the remaining broad-spectrum antibiotics. Bioparox Spray also has an independent anti-inflammatory effect by blocking the inflammation mediators: Bioparox Spray inhibits the synthesis of free radicals and the action of IL1 and TNF as pro-inflammatory factors, and it potentiates the action of IL2 and interferon-gamma which are anti-inflammatory factors. By its dual antibiotic and anti-inflammatory action Bioparox Spray is an excellent alternative to the conventional antibiotic therapy.

Topics: Aerosols; Anti-Bacterial Agents; Anti-Inflammatory Agents; Depsipeptides; Double-Blind Method; Fusarium; Humans; Respiratory Tract Infections

The aim of the study was to estimate by means of acoustic rhinometry (AR) the nasal blockade in 37 patients (5-73 years old, mean 32) with upper airways infections treated by fusafungine. The examinations were carried out on the first (D1) and seventh day (D7) of observation. Cross-sectional area (CA) mean values of 3 cm sector laid back to C notch of AR curves (CA-C3) were selected to the analysis.. The mean value of CA-C3: in all patients it was 2.61 cm2 on D1 and 2.8 cm2 on D7; in rhinitis and sinusitis patients--2.23 cm2, in others--3.16 cm2; without nasal discharge--3.48 cm2, in others (with severe or medium)--2.53 cm2 and 2.48 cm2 respectively. 29 patients had nasal blockade (78.4%) with mean CA-C3 = 2.34 cm2 (others--3.56, p < 0.05). During seven days the following enlargement of CA-C3 was reported: 14.9% in all patients (p < 0.01); in viral infections 24% (n = 14, p < 0.01), bacterial 14.3% (n = 11, NI); in nasal blockade patients--15.22%, others--13.55% (p < 0.01). Mean value of CA-C3 increased by 37.7% in patients who demonstrated, according to the physicians, "very good improvement", 5.7%--"good", 1.5%--"weak" (p < 0.05). There was also enlargement of nasal cavities in CA-C3 in non-sneezers (p < 0.05) and medium discharge symptom patients (p < 0.05). There was no statistical difference in clinical and acoustic rhinometry results between patients treated with fusafungine together with non-steroid anti-inflammatory drugs and patients treated with fusafungine.. AR is a good instrument to be used in the objective assessment of the nasal blockade changes in people with infection of the nasal mucosa and showed positive efficacy of fusafungine in the treatment of upper airway infection.

Topics: Acoustics; Adolescent; Adult; Aerosols; Aged; Anti-Bacterial Agents; Child; Child, Preschool; Depsipeptides; Female; Fusarium; Humans; Male; Middle Aged; Nasal Obstruction; Paranasal Sinuses; Respiratory Tract Infections; Rhinitis; Sinusitis

Knowledge on unintended consequences of product withdrawals is limited. Fusafungine, indicated for treatment of upper respiratory airways disease (URAD), was withdrawn in the EU on May 28, 2016. Given concerns about possible substitution with antibiotics, this study aimed to assess the impact of the withdrawal of fusafungine on prescribing of antibiotics and other treatments.. The study was conducted using data from general practitioner (GP) and ear, nose and throat (ENT) practices in IMS® Disease Analyzer Germany. The quarterly prevalence of fusafungine prescribing was analysed for consultations involving the most common URAD between May 29, 2013 and May 28, 2017 in regular fusafungine-prescribing practices. Trends in the quarterly prevalence of antibiotics (AB), other nasal or throat preparations (N&T) and tyrothricin were analyzed. Practices with no fusafungine prescribing during the study served as controls. Changes in prescribing trend were evaluated using interrupted time series regression analysis.. In fusafungine-prescribing practices, withdrawal of fusafungine was associated with an immediate increase in prescribing of other N&Ts among patients consulting for URAD (+ 6.4%, 95% CI 2.3-10.5% in GP practices and + 9.0%, 95% CI 5.5-12.5% in ENT practices). There was no increase in antibiotic prescribing. In ENT practices; a small transient increase in tyrothricin prescribing occurred. No changes were seen in non-fusafungine-prescribing practices.. Withdrawal of fusafungine was not associated with increased prescribing of antibiotics but was associated with increased prescribing of other N&Ts. The unintended impact of substitution to other treatments should be considered routinely when products are withdrawn or restricted in other ways.

Topics: Anti-Bacterial Agents; Depsipeptides; Germany; Humans; Pharmacovigilance; Practice Patterns, Physicians'; Respiratory Tract Infections; Safety-Based Drug Withdrawals

Topics: Anti-Bacterial Agents; Asthma; Depsipeptides; Fusarium; Humans; Respiratory Tract Infections; Rhinitis, Allergic, Perennial

Despite attempts to limit their use, systemic antibiotics are extensively prescribed for respiratory infections in France. This survey analyzed data from the Thales database, which contains information from 1010 representative French general practitioners (GPs). The objective was to assess French GP prescribing patterns in upper respiratory tract infections (URTIs) including the rate of prescription of systemic antibiotics and anti-inflammatory drugs in the presence or absence of prescribing fusafungine (Locabiotal) an antibiotic with anti-inflammatory activity indicated for local use in URTIs. Drug costs to the French National Sickness Fund were also assessed.. This was a retrospective, longitudinal, case-control analysis. Prescribing patterns and costs were compared between patients who did and patients who did not receive fusafungine for a URTI (rhinopharyngitis, tonsillitis, or an influenza-like condition). The fusafungine group consisted of all patients in the database who were prescribed fusafungine at least once between 1 December 1999 and 30 November 2000. The control group was made up of randomly selected patients, matched for age and sex with the study group, who received at least one drug prescription (but not fusafungine) for a URTI during the same period. Patients were selected at the time of their first prescription, and their records for 1 year were analyzed.. Each group contained 22 164 patients. For URTIs overall, systemic antibiotics were widely prescribed (at a rate of 54.6% and 67.8% in the fusafungine and control groups, respectively; p < 0.01). The rate of prescription of systemic antibiotics, NSAIDs and corticosteroids per prescription and per episode was significantly lower in the fusafungine group than in the control group. The mean cost per prescription for the French National Sickness Fund was significantly lower for the three URTIs overall when fusafungine was prescribed (9.21 euros [euro] vs euro9.67; p < 0.01). The mean cost to the National Sickness Fund per prescription of systemic antibiotics, NSAIDs, and corticosteroids was also significantly lower in the fusafungine group compared with the control group. The cost of nasal preparations was higher in the fusafungine group because Locabiotal is classified as a nasal preparation. The cost per prescription to the National Sickness Fund was increased by the presence of systemic antibiotics, NSAIDs, or corticosteroids among the prescribed drugs and decreased with the prescription of fusafungine.. When fusafungine was prescribed for URTIs, fewer systemic antibiotics were prescribed, an important result in the current context of concern about emerging antibiotic resistance. The use of fusafungine was associated with a lower mean cost per prescription to the French National Sickness Fund.

Topics: Adolescent; Adult; Aerosols; Aged; Anti-Bacterial Agents; Case-Control Studies; Child; Child, Preschool; Depsipeptides; Drug Prescriptions; Drug Utilization; France; Fusarium; Humans; Infant; Middle Aged; Physicians, Family; Practice Patterns, Physicians'; Respiratory Tract Infections

Topics: Aerosols; Anti-Bacterial Agents; Depsipeptides; Fusarium; Humans; Respiratory Tract Infections

Various tests were performed to establish the bacteriological potency of Locabiotal, an aerosol for local application to the nose and throat containing fusafungine. Using impregnated filter paper on a plate of solid sensitivity media considerable inhibition of the growth of common pathogens was shown. Plates of nasal swabs from adults and buccal swabs from children showed similar inhibition. Further tests after the application of the spray to the nose and throat indicated that inhibition lasts for at least eight hours.

Topics: Adult; Aerosols; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Candidiasis; Child; Depsipeptides; Humans; Microbial Sensitivity Tests; Respiratory System; Respiratory Tract Infections

An open clinical trial of Locabiotal, in which the antibiotic, fusafungine, is presented in a micronized aerosol was performed in general practice. One hundred and ten patients suffering from upper respiratory infections without associated hyperpyrexia or toxic symptoms were treated for 7 days. There was a marked improvement in the symptoms rated during the first 48 hours. After the full course of treatment 37 patients regarded its effect as excellent and 48 as good.

Topics: Adolescent; Adult; Aerosols; Aged; Anti-Bacterial Agents; Child; Child, Preschool; Common Cold; Depsipeptides; Female; Humans; Laryngitis; Male; Middle Aged; Pharyngitis; Respiratory Tract Infections; Rhinitis