Ciproϐloxacin in Otitis Externa Management: Efϐicacy, Safety, and Future Directions

To examine the use of oral ciprofloxacin and parenteral antimicrobials in the treatment of acute infection (respiratory tract, urinary tract, blood) in hospitalized patients, with particular reference to severity of infection, outcome, and associated economic implications of each treatment. A prospective, multicenter comparative audit was conducted in the UK over an 18-month period. The audit was undertaken by clinical pharmacists who reviewed the antimicrobial treatment of patients with infective episodes, who were receiving or could have received oral therapy. Clinical pharmacists who collated the data all are employed in teaching hospitals. Patients were identified for analysis by their type of infection, severity of illness, antimicrobial prescribed, route of administration, and response to therapy. Additionally, data on costs of the antimicrobials prescribed and the supplementary costs of drug administration were calculated. Four hundred eighty-five patients were enrolled for analysis; 208 of the patients had respiratory tract infection, 112 had urinary tract infection, 138 had septicemia, and 27 had mixed infections. Sepsis scores were applied to 152 patients receiving oral ciprofloxacin and 333 patients receiving parenteral antimicrobials and yielded mean scores of 5.9 (SD 3.1, range 1-13) and 8.7 (SD 4.2, range 1-22), respectively. Of 485 patients, 188 were paired according to sepsis score results and route of administration. Resolution occurred in 133 patients (79 receiving oral and 54 receiving parenteral therapy), further therapy was required in 49 (11 oral and 38 parenteral), and treatment was withdrawn in 6 (4 oral and 2 parenteral). Microbiologic assessment yielded positive results in 227 patients (47 percent). Drug acquisition costs (based on 1 UK pound = 1.80 US $) per course of treatment were $47.23 (SD $38.32, range 5.40-218.70) for the oral group and $173.70 (SD 209.77, range 2.11-1021.40) for the parenteral group. Overall costs for treatment courses were $74.00 (SD $52.81, range 8.10-309.17) and $305.59 (SD $304.70, range 14.69-1345.00) for the two groups, respectively (p < 0.001). This study suggest that, in patients with moderate infective episodes, oral ciprofloxacin may reduce overall treatment costs compared with the use of parenteral antimicrobial agents.

Background: A suppurative Middle ear infection is the most frequent kind of otitis externa in low-income regions of the world (CSOM). Suppurative otitis media (CSOM-tubo tympanic type) affects both young and old alike. The condition has been treated using a wide range of approaches. Objectives: The purpose of this study was to evaluate the efficacy of oral and topical ciprofloxacin against topical ciprofloxacin drops alone in the treatment of CSOM-tubo tympanic ear discharge. Methods: Randomization was used in our study Patients with chronic suppurative otitis media were seen between September 2020 and September 2021 at tertiary care hospital in Peshawar. SPSS version 24 was used to evaluate hospital and pathology lab data. Results: Overall, 75 patients were included in the study's findings. They split themselves into two categories. There were 38 people [group A] and 37 people [ group B]. each Group was classified into two age groups, the younger [ages 01–12] and the older (ages 13–60). (age 13-16 years). Patients' ages ranged from 1 to 12 years old, with 28 [group-A] at 72% and 25 [group-B] at 65%. Ten people 27% in [group-A] and thirteen patients (35%) in [group B], were between the ages of thirteen and sixteen (group B). Conclusions: As a result, we found that the combination of oral and topical ciprofloxacin was superior to topical ciprofloxacin alone in resolving ear discharge in patients with middle ear CSOM (tubo-tympanic type). Keywords: Topical and oral ciprofloxacin, treat chronic suppurative, otitis media

SUMMARYObjectives: To compare the efficacy and safety of ciprofloxacin 0.3%/dexamethasone 0.1% (CIP/DEX) otic suspension with that of neomycin 0.35%/polymyxin B 10 000 IU/mL/hydrocortisone 1.0% (N/P/H) otic suspension in patients with acute otitis externa (AOE).Study Design: Randomized, observer-masked, parallel-group, multicenter study. Patients were randomized to 7 days treatment with either CIP/DEX 3–4 drops twice daily or N/P/H 3–4 drops three times daily.Population: Patients of either sex and older than 1 year, with a clinical diagnosis of mild, moderate, or severe AOE and intact tympanic membranes were recruited to participate.Outcomes Measured: Signs and symptoms of AOE, including ear inflammation, tenderness, edema and discharge (assessed on Days 3, 8 [End-of-Therapy] and 18 [Test-of-Cure]); microbiologic eradication (presumed or documented); and frequency of adverse events.Results: Patients enrolled numbered 468. In culture-positive patients who met the inclusion criteria (N = 396), clinical cure rates at Day 18 were significantly higher with CIP/DEX than with N/P/H (90.9% vs. 83.9%; p = 0.0375), as were microbiologic eradication rates (94.7% vs. 86.0%; p = 0.0057). In addition, the clinical response was significantly better with CIP/DEX than with N/P/H at Days 3 and 18 (p = 0. 0279 and p = 0. 0321, respectively), as was the reduction in ear inflammation at Day 18 (p = 0.0268). Both preparations were well tolerated in pediatric and adult patients.Conclusions: 7 days treatment with CIP/DEX otic suspension administered twice daily is clinically and microbiologically superior to N/P/H otic suspension administered 3 times daily in the treatment of mild to severe AOE, and is equally well tolerated.

Despite the widespread use of quinolones to treat infections of the ears, nose, and throat, well-controlled studies are uncommon. Malignant (necrotizing) external otitis is an invasive infection of the external auditory canal and skull base, whose typical host is the elderly patient with diabetes mellitus. With the advent and widespread use of quinolones for all ear infections, patients with malignant external otitis are being diagnosed and treated earlier in the course of the disease, thus changing the clinical spectrum of this infection. Oral ciprofloxacin has been used successfully for individuals with auricular perichondritis. Potential limitations of oral quinolones for the treatment of soft-tissue infections of the auricle are suggested by reports of phototoxic lesions induced by quinolones in the auricular skin of mouse models. Cumulative evidence supports the utility of quinolones for treatment of chronic ear infections with multiresistant bacterial. Infections of the ear, nose, and throat are among the most common outpatient maladies in the world. Oral quinolones are the drugs of choice for the treatment of disease caused by Pseudomonas aeruginosa, including malignant external otitis and auricular perichondritis. Similarly, there appears to be little rationale for the use of quinolones as initial therapy for otitis media, sinusitis, or pharyngotonsillitis. In fact, pneumococcal bacteremia following ciprofloxacin therapy for acute otitis media has been reported.

Malignant otitis externa in an infant with selective IgA deficiency: a case report

Recently, a total of 74 Staphylococcus pseudintermedius isolates were collected from clinical cases of canine pyoderma and otitis externa in Korea. In this study, we examined in vitro fluoroquinolone resistance among those isolates using a standard disk diffusion technique. The results demonstrated that approximately 18.9% to 27.0% of the isolates possessed bacterial resistance to both veterinary- and human-licensed fluoroquinolones except one isolate, including moxifloxacin (18.9% resistance), levofloxacin (20.3% resistance), ofloxacin (24.3% resistance), ciprofloxacin (25.7% resistance), and enrofloxacin (27.0% resistance). Most surprisingly, 14 out of 74 (18.9%) isolates were resistant to all the five fluoroquinolones evaluated. Moreover, a PCR detection of the methicillin resistance gene (mecA) among the 74 isolates revealed that 13 out of 25 (52.0%) mecA-positive isolates, but only 7 out of 49 (14.3%) mecA-negative isolates, were resistant to one or more fluoroquinones. Taken together, our results imply that bacterial resistance to both veterinary- and human-use fluoroquinolones becomes prevalent among the S. pseudintermedius isolates from canine pyoderma and otitis externa in Korea as well as that the high prevalence of the mecA-positive S. pseudintermedius isolates carrying multiple fluoroquinolone resistance could be a potential public health problem.

Background: Malignant external otitis (MEO) is a relatively uncommon infection caused by Pseudomonas aeruginosa seen primarily in immunocompromised patients, classically, diabetics. MEO is treated effectively with antibiotics but can be associated with significant morbidity including cranial nerve palsies. Objective: To report a case of MEO seen in a patient with myelodysplastic syndrome and prolonged neutropenia whose infection was resistant to all of the commonly used antibiotics, including fluoroquinolones, third generation cephalosporins, aminoglycosides, aztreonam, imipenem, and extended spectrum penicillins. Although there have been reports of ciprofloxacin resistant P. aeruginosa causing MEO infections, we were unable to locate any cases in the literature resistant to both ciprofloxacin and third generation cephalosporins. Method: To treat our patient’s MEO, we employed colistin, an antibiotic seldom used since the early 1980’s due to its nephrotoxicity. Results: The infection responded well to colistin, and with intermittent dosing, the patient did not suffer from deterioration of renal function and colistin resistance did not develop. Unfortunately, the case was also complicated by bilateral facial palsy and long-term bilateral hearing loss, two complications, which although common in this disease, are rarely seen in a bilateral fashion.

Introduction: Chronic suppurative otitis media (CSOM) is defined as a chronic inflammation of the middle ear and mastoid cavity, which presents with recurrent ear discharge or otorrhea through a tympanic perforation. Aim: The study aimed to compare the effectiveness of topical versus combined (systemic and topical) therapy in ciprofloxacin-sensitive CSOM (tubotympanic). Materials and Methods: A hospital-based prospective study of 100 patients aged &gt;18 years with clinically diagnosed CSOM (tubotympanic type) was conducted. After aural toilet, patients were randomly assigned to one of the two treatment groups: Group A (topical ciprofloxacin ear drops) Group B (topical plus oral ciprofloxacin). These patients were received 1 week of treatment and followed up on day 3 and day 7. Statistical comparisons were performed using Chi-square test. Results: In this study, maximum numbers of patients were found in the age group of 20–29 years. Patients in Group A (topical ciprofloxacin ear drops) showed less side effects in comparison to Group B (topical plus oral ciprofloxacin). Forty-one (82%) patients showed improvement in Group A, whereas 43 (86%) patients in Group B. Conclusion: Topical ciprofloxacin drops were as effective as combined (oral plus topical ciprofloxacin) and that the addition of oral drug did not have any beneficial effect adding only to the side effects and to the cost of treatment.

To evaluate the mortality and morbidity associated with early discontinuation of intravenously administered antibiotics, we prospectively examined the incidence and cause of recurrent fever in patients with persistent neutropenia who responded to a short course of intravenous antibiotic therapy. Preventive measures included the use of oral ciprofloxacin as prophylaxis for infection by gram-negative bacteria during the entire neutropenic episode. The rate of response to either initial or modified intravenous antibiotic therapy was 96% (149 of 156 episodes of fever). Eighty-five patients had an episode of persistent neutropenia (median duration, 7 days; range, 1-36 days) after they responded to treatment. Seven of these patients had recurrent fever, including 2 with bacteriologically documented infections, 4 with probable fungal pneumonia, and 1 with documented pneumonia due to Aspergillus fumigatus. Two patients with probable fungal pneumonia died, while the other infectious episodes resolved completely. These results do not support the continuation of intravenous antibiotic therapy for febrile patients with persistent neutropenia who have responded to the antibiotic regimen while receiving prophylaxis with oral ciprofloxacin.

BackgroundThe role of oral antibiotic therapy in treating infective endocarditis (IE) is not well established.MethodsWe searched MEDLINE, EMBASE and Scopus for studies in which oral antibiotic therapy was used for the treatment of IE.ResultsSeven observational studies evaluating the use oral beta-lactams (five), oral ciprofloxacin in combination with rifampin (one), and linezolid (one) for the treatment of IE caused by susceptible bacteria reported cure rates between 77% and 100%. Two other observational studies using aureomycin or sulfonamide, however, had failure rates >75%. One clinical trial comparing oral amoxicillin versus intravenous ceftriaxone for streptococcal IE reported 100% cure in both arms but its reporting had serious methodological limitations. One small clinical trial (n = 85) comparing oral ciprofloxacin and rifampin versus conventional intravenous antibiotic therapy for uncomplicated right-sided S. aureus IE in intravenous drug users (IVDUs) reported cure rates of 89% and 90% in each arm, respectively (P =0.9); however, drug toxicities were more common in the latter group (62% versus 3%; P <0.01). Major limitations of this trial were lack of allocation concealment and blinding at the delivery of the study drug(s) and assessment of outcomes.ConclusionReported cure rates for IE treated with oral antibiotic regimens vary widely. The use of oral ciprofloxacin in combination with rifampin for uncomplicated right-sided S. aureus IE in IVDUs is supported by one small clinical trial of relatively good quality and could be considered when conventional IV antibiotic therapy is not possible.

The effect of the use of oral ciprofloxacin on patient outcome and the cost of antimicrobial therapy was investigated. In 1988 ciprofloxacin was placed on the antimicrobial formulary at a Veterans Affairs medical center. Patients with urinary tract infections, soft tissue infections, osteomyelitis, or pneumonia due to organisms that were documented as being susceptible to ciprofloxacin and either resistant to other oral antimicrobials or susceptible to other oral antimicrobials in patients allergic to such agents were monitored in a prospective open study over 12 months. When a patient was enrolled, the physician was asked to select the i.v. antimicrobial regimen that would have been used if ciprofloxacin were not available. Patient outcome was determined from medical records, and the difference in the costs of the oral and i.v. regimens was calculated. Clinical cure occurred in 96/100 (96%) of patients with urinary tract infection, 19/22 (86%) with soft tissue infection, 14/16 (88%) with osteomyelitis, and 10/12 (83%) with pneumonia. The overall cure rate was 139/150 (93%). The 11 clinical failures occurred in patients infected with methicillin-resistant Staphylococcus aureus (MRSA) alone, group D enterococcus alone, MRSA and Pseudomonas sp., and Pseudomonas sp. alone. The total cost avoidance achieved by using oral ciprofloxacin instead of i.v. antimicrobials was $77,158. Oral ciprofloxacin was an effective and cost-efficient alternative to traditional i.v. antimicrobial therapy in the patients studied.

An elderly male with type 2 diabetes presented with a 2-month history of otalgia and severe headaches. He was diagnosed with malignant otitis externa (MOE) and was commenced on empirical treatment with oral ciprofloxacin. Pseudomonas is the most common cause of MOE. A baseline CT scan was undertaken that demonstrated skull base osteomyelitis (SBO) due to findings of bone erosion at the mastoid tip and an infiltrating soft tissue mass eroding the clivus. Eight weeks later, he returned with worsening and bilateral symptoms of otitis externa, hearing loss, temporomandibular pain and dysfunction. Worsening and now bilateral malignant otitis externa were confirmed with an MRI scan that also demonstrated a small fluid collection in his left temporal region. The collection was aspirated and grew scedosporium apiospermum. He was diagnosed with fungal SBO and was commenced on treatment with the antifungal voriconazole, with significant improvement in symptoms and radiological findings. Fungal osteomyelitis is more likely in immunosuppressed patients, particularly those with type 2 diabetes. Fungal aetiology should be suspected in patients with progressive symptoms, despite treatment. A microbiology diagnosis of fungal SBO or MOE can be challenging to obtain and can lead to diagnostic delay. A sampling of the external auditory canal can aid in diagnosing MOE; however, scedosporium may also be isolated as a commensal organism. Aspirations from accessible fluid collections, infratemporal fossa needle sample and bone biopsy can provide material for diagnosis. Scedosporium is a rare cause of disease in humans, however, fungal infections are increasing in humans, due to an increase in susceptible populations. Scedosporium apiospermum is a rare cause of SBO and should be considered in patients not responding to standard treatment.

More than $2.4 billion is spent annually on oral antibiotics. Their inappropriate use is common, and newer ones offer expanded and expensive opportunities for abuse. Ciprofloxacin, an oral quinolone with systemic absorption and broad antimicrobial spectrum, illustrates this pattern. Since its release in the US in October 1987, ciprofloxacin has rapidly become one of the most frequently prescribed oral antibiotics. We have observed widespread inappropriate use of ciprofloxacin and describe several patterns of misuse. The activity of ciprofloxacin against streptococci, anaerobic organisms, and Mycoplasma ranges from intermediate to poor. Properly used, ciprofloxacin can extend the range of oral therapy. However, ciprofloxacin is inappropriate initial therapy for common outpatient infections, including otitis media, sinusitis, pharyngitis, and pneumonia.

BackgroundFluoroquinolones have been associated with hypoglycemia in patients taking diabetic medications, most commonly due to drug-drug interactions and other associated risk factors. Except for four published case reports, there are no studies that have found positive associations between ciprofloxacin and hypoglycemia. In all but one of the cases, ciprofloxacin was taken with other hypoglycemic drugs. Recently, the Eritrean National Pharmacovigilance Centre received a serious case of hypoglycemia with recurrent episodes in a young and healthy patient without diabetes following use of oral ciprofloxacin. The aim of the present study is therefore to assess the causal relationship between ciprofloxacin and hypoglycemia in patients without diabetes using the World Health Organization-Uppsala Monitoring Centre global adverse drug reaction database (VigiBase®).MethodsA search was made on the World Health Organization global adverse drug reaction database (August 15, 2018) using “ciprofloxacin” as the drug substance and “hypoglycemia” as the reaction term. Cases that used hypoglycemic drugs (patients with diabetes) concurrently with ciprofloxacin and those with a completeness score below 50% were excluded to control for confounders and to improve the strength of the data. Hill criteria were used to assess causation.ResultsA total of 35 cases of hypoglycemia reported since 1989 from 17 countries in patients without diabetes associated with ciprofloxacin use with a median time to onset of 4 days were retrieved. The cases have a median age of 64 years (interquartile range, 50–85) with a similar male–to-female ratio. Ciprofloxacin was the only suspect and the sole drug administered in 48.5% of the cases. In ten cases, hypoglycemia abated following withdrawal of ciprofloxacin, and reaction recurred in one case on the subsequent rechallenge. Hypoglycemia was marked as “serious” in 20 cases, and the outcome was fatal in two cases.ConclusionsThis assessment found a suggestive causal link between use of ciprofloxacin and hypoglycemia in patients without diabetes.

Malignant otitis externa (MOE) is a potentially life-threatening infection of the soft tissues of the external ear, quickly spreading to involve the periosteum and bone of the skull base. Treatment includes antibiotics and eventually surgery. Hyperbaric oxygen treatment (HBOT) has been proposed as an adjunctive therapy. However, in the tenth consensus conference, this disease was considered as a non-indication for HBOT. The aim of this study was to evaluate the effectiveness of HBOT in MOE treatment. Retrospective and observational study was conducted of patients with MOE treated in our centre. Staging of the disease was made according to the clinicopathological classification system. From March 1998 to November 2016, 16 patients were referred. 6% patients were on stage 1 of the disease at the time they were referred, 20% in stage 2, 7% in stage 3a, 13% in stage 3b and 53% in stage 4. Seven (43.75%) patients had VII nerve palsy and three (18.75%) patients had multiple nerve palsy. Average length of symptoms of disease was 5months (maximum 11months). Average number of sessions was 33 and the length of hospitalization prior to HBOT (median 90 days) was significantly longer than the time between beginning HBOT and cure (p = 0.028, Wilcoxon signed rank test). There were no fatalities due to MOE and all patients were considered free of disease after HBOT. HBOT was well tolerated and revealed to be a helpful adjuvant treatment in MOE. According to our data, HBOT should be considered for patients who failed conventional treatments and in severe cases.