Cefdinir: a review of its use in the management of mild-to-moderate bacterial infections

Cefdinir (Omnicef) is an oral third-generation cephalosporin with good in vitro activity against many pathogens commonly causative in community-acquired infections. The drug provides good coverage against Haemophilus influenzae, Moraxella catarrhalis and penicillin-susceptible Streptococcus pneumoniae, the most common respiratory tract pathogens. Cefdinir is stable to hydrolysis by commonly occurring plasmid-mediated beta-lactamases and retains good activity against beta-lactamase-producing strains of H. influenzae and M. catarrhalis. The drug distributes into various tissues (e.g. sinus and tonsil) and fluids (e.g. middle ear), and has a pharmacokinetic profile that allows for once- or twice-daily administration.Cefdinir, administered for 5 or 10 days, has shown good clinical and bacteriological efficacy in the treatment of a wide range of mild-to-moderate infections of the respiratory tract and skin in adults, adolescents and paediatric patients in randomised, controlled trials. In adults and adolescents, cefdinir is an effective treatment for both lower (acute bacterial exacerbations of chronic bronchitis [ABECB], community-acquired pneumonia) and upper (acute bacterial rhinosinusitis, streptococcal pharyngitis) respiratory tract infections, and uncomplicated skin infections. Its bacteriological and clinical efficacy in patients with lower respiratory tract infections was equivalent to that of comparator agents (cefprozil [bacteriological only], loracarbef, cefuroxime axetil and cefaclor). In one trial in patients with ABECB, cefdinir produced a higher rate of clinical cure than cefprozil (95% CIs indicated nonequivalence). Cefdinir also produced good clinical and bacteriological responses equivalent to responses with amoxicillin/clavulanic acid in patients with acute bacterial rhinosinusitis. In addition, it was at least as effective as penicillin V (phenoxymethylpenicillin) in streptococcal pharyngitis/tonsillitis and as effective as cefalexin in uncomplicated skin infections. In paediatric patients aged > or =6 months, cefdinir showed similar efficacy to that of amoxicillin/clavulanic acid or cefprozil in acute otitis media, and cefalexin in uncomplicated skin infections. Cefdinir given for 5 or 10 days was at least as effective as penicillin V for 10 days in patients with streptococcal pharyngitis/tonsillitis. Cefdinir is usually well tolerated. Diarrhoea was the most common adverse event in trials in all age groups. Although the incidence of diarrhoea in cefdinir recipients was generally higher than in adults and adolescents treated with comparators, discontinuation rates due to adverse events were generally similar for cefdinir and comparator groups.In conclusion, cefdinir is a third-generation cephalosporin with a broad spectrum of antibacterial activity encompassing pathogens that are commonly causative in infections of the respiratory tract or skin and skin structure. Depending on the infection being treated, cefdinir can be administered as a convenient once- or twice-daily 5- or 10-day regimen. Clinical evidence indicates that cefdinir is an effective and generally well tolerated drug with superior taste over comparator antibacterial agents and is therefore a good option for the treatment of adults, adolescents and paediatric patients with specific mild-to-moderate respiratory tract or skin infections, particularly in areas where beta-lactamase-mediated resistance among common community-acquired pathogens is a concern.     

Prevention of recurrent upper respiratory tract infections in a community of cloistered nuns using a new immunostimulating bacterial lysate. A randomized, double-blind clinical trial

The aim of the present study was to evaluate the efficacy of the immunostimulating therapy with a new vaccine Ismigen in preventing recurrent infections of the upper respiratory tract in subjects belonging to a community of cloistered nuns. This product is a lysate obtained by mechanical lysis of bacteria (MLBL) usually responsible of respiratory tract infections. A randomized, double-blind, parallel groups, placebo controlled clinical trial was carried out in 47 nuns (age range 25-80 years) living in a cloistered religious community, suffering from recurrent infections of the upper respiratory tract. The 47 patients were allocated by randomization to two groups: Group A--The 24 patients (mean age SD: 48.12 +/- 14.25 years) of this group received one sublingual tablet of MLBL per day, for 10 consecutive days per month for 3 consecutive months (October, November and December 2001). Group B--The 23 patients (mean age +/- SD: 49.04 +/- 14.73 years) of this group received daily one sublingual tablet of taste masked placebo, for 10 consecutive days per month for 3 consecutive months (October, November and December 2001). At the end of the treatment period patients of both groups were followed up for further three months without any immunostimulating treatment. RESULTS: During and at the end of the treatment phase the number of respiratory infections (primary end-point) and their duration were statistically significantly lower in the MLBL group than in the placebo group. Moreover the administration of MLBL induced a marked reduction in the number of patients showing symptoms of infection in comparison to baseline and approximately 79 % of the patients showed an improvement of one or more of the evaluated symptoms. In the MLBL group a statistically significant increase of serum immunoglobulins (IgG +35%; IgM +86%; IgA +80 %) and salivary IgA (+110%) was found, in comparison to baseline; on the contrary no significant differences were observed in the placebo group. The beneficial effects of MLBL found in the treatment period were maintained also in the three-month follow-up. No adverse events associated with the treatment were found in both group. The results of this study demonstrate that MLBL is an efficacious and safe therapeutic option for the treatment and prevention of recurrent upper respiratory tract infections and that its use is recommended in subjects with a possible immune deficit.     

Bacterial interference for the prevention and treatment of infections

Bacterial interference refers to the antagonism between bacterial species during the process of surface colonisation and acquisition of nutrients. The clinical evidence on the potential applications of microorganisms for the prevention and/or treatment of infections in the upper respiratory, urogenital and gastrointestinal tracts was reviewed through the PubMed and Scopus databases. Data regarding factors that may affect the human microflora, thus contributing to tissue colonisation from potential pathogens, were also retrieved. The clinical evidence for application of the interfering ability of non-virulent bacteria to prevent or treat infections has been rather limited, although promising for certain purposes. A number of relevant preliminary trials suggest that in the upper respiratory tract the rate of recurrence of otitis media or streptococcal pharyngotonsillitis appears to decrease using selected bacteria with inhibitory ability against common pathogens of upper respiratory tract in combination with appropriate antibiotic treatment. Regarding the urogenital tract, specific non-pathogenic strains of Escherichia coli and probiotic organisms were successfully applied to decrease the recurrence of local infections. The interfering ability of specific probiotic organisms (strains of Lactobacilli and Bifidobacteria) within the gastrointestinal tract against common pathogens was also demonstrated. In conclusion, randomised controlled trials are warranted to investigate the effectiveness and safety of potential applications of the principle of bacterial interference in the prevention and treatment of infections of various sites. Such trials should initially employ selected strains of probiotics for which there are preliminary data regarding their effectiveness and lack of common or serious toxicity.     

Cefodizime. A review of its antibacterial activity, pharmacokinetic properties and therapeutic use.

Cefodizime is a third generation cephalosporin with a broad spectrum of antibacterial activity. Administered intravenously or intramuscularly, cefodizime 1 to 4 g daily for an average of 7 to 10 days produced clinical cure in 80 to 100% of patients (adults, elderly or children) with upper or lower respiratory tract infections or urinary tract infections, and in comparative trials cefodizime was as effective as other third generation cephalosporins. A single dose of cefodizime 1 or 2 g is also useful in treating lower urinary tract infections, particularly uncomplicated infections, with a rate of clinical success of 72 to 88%. Urogenital gonorrhoea, whether caused by beta-lactamase producing or non-beta-lactamase producing Neisseria gonorrhoeae, is very effectively treated by single dose therapy with intramuscular cefodizime 0.25 to 1 g (virtually 100% cured). Preliminary data from a small number of patients indicate that cefodizime may also be useful in the treatment of otitis media, sinusitis and gynaecological infections, and for the prophylaxis or treatment of surgical infections. The clinical efficacy of cefodizime in comparison with other third generation cephalosporins is superior to that predicted from in vitro results. This superior activity of cefodizime may be related to the relatively long elimination half-life of the drug or its ability to modify some functions of the immune system--a potentially important finding awaiting further investigation. Cefodizime is well tolerated and has a tolerability profile similar to other members of its class with systemic adverse events being primarily gastrointestinal or dermatological. Thus, limited comparative studies indicate cefodizime has the potential to become a useful alternative to current antimicrobial therapy for the treatment of a variety of infections. Cefodizime may be more convenient to administer than some other agents of its class as it may be given once or twice daily. While there are no trials comparing cefodizime to other third generation cephalosporins in immunosuppressed populations, preliminary information indicates cefodizime may be useful in this group.     

中成药治疗妊娠期急性上呼吸道感染观察

目的：观察和探讨中成药治疗妊娠期上呼吸道感染的疗效和安全性.方法：将102例妊娠期上呼吸道感染病例随机分为观察组（n=52）和对照组（n=50）;观察组在采用对照组相同治疗方法的基础上,给予大卫颗粒口服,并随证加用其它中成药联合治疗.结果：观察组疗效明显好于对照组（P＜0.05）,2组均未发生不良反应.结论：中成药为主治疗妊娠期上呼吸道感染疗效明显,安全方便,孕妇易于接受.     

Evaluation of Antitussive Agents in Man

Methodology to evaluate the efficacy of antitussive drugs rely largely on subjective methods and cough counts. There are few studies in cough due to natural disease especially using objective techniques. This paper presents data from a series of randomized, double blind, placebo controlled clinical trials in cough due to both chronic bronchopulmonary disease and acute upper respiratory tract infections. In these studies, cough was quantified using a standardized and validated computerized system for the acquisition and multidimensional analysis of the cough sound. Key objective parameters like cough counts, intensity, latency and total effort expended were studied. Guaiphenesin and bromhexine showed significant expectorant effects in patients with productive cough due to chronic bronchopulmonary disease. Differences were observed in speed of action, and objective and subjective measures, that probably indicate differences in drug action. More recently, three studies evaluated the antitussive drug dextromethorphan in non-productive cough due to uncomplicated upper respiratory tract infections. Reproducible cough suppressant effects were demonstrated after a single 30 mg dose using objective measures of cough counts, latency and total effort. These results establish the sensitivity and robustness of the cough quantitation methodology in the objective evaluation of cough treatments.     

Advances in respiratory syncytial virus vaccine development

Respiratory syncytial virus (RSV) is the most important causative agent of respiratory tract infections. Young children with chronic lung or congenital heart disease are at increased risk for severe disease. Intensive research into a candidate vaccine has yielded live attenuated vaccines and subunit vaccines, which have been studied in humans. Although immunogenic, occurrence of upper respiratory tract infection symptoms with live attenuated vaccine prohibits evaluation in young infants. Subunit vaccines include purified F protein (PFP-1 and -2) and BBG2Na. PFP vaccines are effective in seropositive children, but also induce upper respiratory symptoms. BBG2Na was being investigated in phase III clinical trials, however, further development has now been discontinued. This review discusses recent advances in RSV vaccine development.     

Oseltamivir

Oseltamivir is the oral prodrug of GS4071, a selective inhibitor of influenza A and B viral neuraminidase. After absorption from the gastrointestinal tract oseltamivir is efficiently converted to GS4071, which is maintained at high and sustained concentrations in plasma. Based on studies in rats and ferrets, GS4071 appears to be effectively distributed to all tissues, including major sites of infection in the upper and lower respiratory tracts. Oral oseltamivir was an effective treatment in naturally occurring influenza when administered within 36 hours of symptom onset, reducing both the duration and severity of symptoms and the incidence of secondary complications in influenza-infected patients enrolled in 2 large placebo-controlled, double-blind trials. Prophylactic oral administration of oseltamivir was effective in reducing the incidence of influenza illness according to pooled data from 2 large placebo-controlled, double-blind trials of healthy nonimmunised volunteers during periods of seasonal influenza activity. The reported incidence of viral resistance to GS4071 was low in clinical isolates from oseltamivir treatment studies. All known GS4071 resistant genotypes are growth disadvantaged and display significantly reduced infectivity in animals. Oseltamivir was well tolerated in human volunteers and patients in clinical trials. Treatment-related adverse events (primarily gastrointestinal) were mild and transient in nature.     

小儿热感宁口服液治疗小儿急性上呼吸道感染的临床观察

目的 :观察小儿热感宁口服液对小儿急性上呼吸道感染的临床症状和体征的改善作用。方法 :161例急性上呼吸道感染患儿随机分成3组 ,分别口服小儿热感宁口服液 (60例 )、双黄连口服液 (41例 )及维C银翘冲剂 (60例 )进行治疗 ,均日服3次～4次 ,3天为1疗程 ,观察服药前和服药3天患儿的咳嗽、流涕、精神不振、食欲下降、睡眠不佳等临床症状和咽充血、扁桃体肿大等体征的变化 ,并对组间的有效率进行比较。结果 :小儿热感宁口服液对小儿急性上呼吸道感染临床症状和体征的改善作用明显优于对照组(P<0 05)。观察期间 ,小儿热感宁口服液组未发现明显的不良反应。结论 :小儿热感宁口服液是一种可改善小儿急性上呼吸道感染临床症状和体征的安全、有效的中药复方制剂     

健儿清解液治疗儿童急性上呼吸道感染临床观察

目的:探讨治疗急性上呼吸道感染的新途径。方法:选择本院门诊及病房诊为上呼吸道感染者66例,急性起病,病程≤3 d,外周血象正常者,并具有胃肠型感冒的症状及体征,随机分为对照组31例和治疗组35例,两组年龄、性别、病程、病情程度等统计学处理无显著性差异。对照组给予对症处理,治疗组在对症处理的基础上口服健儿清解液3 d。观察发热、咳嗽、流涕、鼻塞、咽痛、口腔糜烂、食欲下降、恶心、腹胀、呕吐及腹泻等并评分。结果:治疗组总有效率91.4%,对照组总有效率74.2%(P<0.05)。治疗组与对照组比较,治疗组退热效果及对食欲下降、咳嗽、恶心呕吐等的改善均优于对照组,差异有统计学意义。结论:健儿清解液配方合理,口感香甜微酸,服用方便,易为儿童接受,且未见毒副作用,是治疗儿童上呼吸道感染的良药。     

Cefixime. A review of its antibacterial activity. Pharmacokinetic properties and therapeutic potential

Cefixime, previously designated FK027, FR17027 and CL284635, is an orally active cephalosporin with a broad spectrum of antibacterial activity in vitro. It is particularly active against many Enterobacteriaceae, Haemophilus influenzae. Streptococcus pyogenes, Streptococcus pneumoniae and Branhamella catarrhalis, and is resistant to hydrolysis by many beta-lactamases. Cefixime has little activity against Staphylococcus aureus and is inactive against Pseudomonas aeruginosa. Cefixime is distinguished by its 3-hour elimination half-life which permits twice daily, or in many instances once daily, administration. Comparative trials, though few, indicate that the clinical and bacteriological efficacy of cefixime 200 to 400mg daily administered as a single dose or in 2 divided doses, is comparable with that of multiple daily doses of co-trimoxazole (trimethoprim + sulphamethoxazole) or amoxycillin in acute uncomplicated urinary tract infection, with that of amoxycillin, amoxycillin/clavulanic acid and cefaclor in acute lower respiratory tract infections, and with that of amoxycillin and cefroxidine in adult patients with acute tonsillitis or pharyngitis. Several comparative trials in children with acute otitis media demonstrate the similar effectiveness of cefixime 8 mg/kg daily (in 2 divided doses, or as a single daily dose), cefaclor 20 to 40 mg/kg daily and amoxycillin 40 mg/kg daily in 3 divided doses. The most frequently reported adverse effects, diarrhoea and stool changes, are usually mild to moderate in severity, transient, and mostly occur in the first few days of treatment with cefixime. Thus, cefixime is an effective orally active cephalosporin with a relatively long elimination half-life permitting a simplified treatment regimen. It is a suitable alternative to cefaclor or amoxycillin in acute otitis media and acute upper and lower respiratory tract infections, and to amoxycillin or co-trimoxazole in acute uncomplicated urinary tract infections.     

Clinical efficacy and safety of cefetamet pivoxil in toddlers

The safety and efficacy of cefetamet pivoxil, an oral cephalosporin of the third generation, have been studied in open, prospective, randomized comparative, clinical trials including 301 toddlers (children aged 1 to 2 years) with upper and lower respiratory tract infections, and urinary tract infections. Cefetamet pivoxil (CAT) syrup formulation was given to 177 toddlers either in the standard dose of 10 mg/kg b.i.d. [n = 116] or 20 mg/kg b.i.d. [n = 61] and 124 toddlers have been treated with comparator drugs [cefaclor, n = 98; phenoxymethylpenicillin, n = 18; amoxicillin plus clavulanic acid; n = 8]. The treatment period was 7 days mainly, except for pharyngotonsillitis for which the treatment duration was 7 or 10 days. The assessment of treatment was based on clinical signs and symptoms primarily in infections of lower respiratory tract and acute otitis media, whereas in patients with pharyngotonsillitis and acute urinary tract infections the bacteriological findings were the main evaluation criteria. The overall therapeutic outcome was successful in 148 (95.4%) of the 155 toddlers to whom CAT was administered and in 87 (85.3%) out of 102 toddlers receiving standard drugs. Adverse events of mild to moderate severity, mainly of gastro-intestinal type (vomiting or diarrhoea) occurred in 14.7% in the patient group receiving CAT, 11.2% in the toddlers receiving the standard dose of CAT, and in 12.9% with the comparator drugs. From the data presented it is concluded that cefetamet pivoxil is efficient and safe in toddlers presenting with community-acquired respiratory and urinary infections mainly caused by S. pneumoniae, H. influenzae, Group A beta-haemolytic streptococci, M. catarrhalis, E. coli, Proteus spp. and K. pneumoniae.     

喜炎平与病毒唑对上呼吸道感染患儿退热效果比较

目的比较喜炎平与病毒唑对上呼吸道感染患儿的退热效果。方法将2011年1月至2013年10月收治的380例急性上呼吸道感染患儿随机分为对照组和治疗组2组,每组190例。对照组给予病毒唑治疗,治疗组给予喜炎平治疗,对比2组患儿退热时间与治疗效果。结果治疗组24 h内退热率、72 h内退热率、平均退热时间均显著优于对照组(P<0.05);2组患儿治疗效果比较,治疗组总有效率显著高于对照组(P<0.05)。结论喜炎平治疗小儿上呼吸道感染可有效降低患儿体温,临床上可减少病毒唑的使用。     

热毒宁和利巴韦林治疗小儿急性上呼吸道感染的临床效果比较

目的研究热毒宁和利巴韦林治疗小儿急性上呼吸道感染临床效果的比较。方法选取2009年5月至2011年12月收治的急性上呼吸道感染符合入选标准的240例患儿,分为病毒唑组117例,热毒宁组123例,观察研究病毒唑组与热毒宁组的临床治疗效果。结果病毒唑组总有效率85.47%,热毒宁组总有效率94.30%,病毒唑组与热毒宁组总有效率比较P<0.05,差异有统计学意义。结论小儿急性上呼吸道感染多为病毒感染造成,但细菌、支原体等也可引起本病的发生,其中病毒感染占70%～80%,主要的病毒为柯萨奇病毒、鼻病毒、埃可病毒、腺病毒、流感病毒、呼吸道合胞病毒、副流感病毒等引起,病毒产生毒素、致热源可使体温升高引起患儿发热同时伴有鼻、咽部、咳嗽、食欲减退、及全身不适感等症状。应用热毒宁治疗小儿急性上呼吸道感染比用病毒唑治疗病程显著缩短,总有效率高,值得临床应用。     

头孢克洛治疗上呼吸道感染的临床观察

目的：探讨头孢克洛治疗上呼吸道感染的临床疗效。方法选取本院2O11年1月-2O13年8月收治的76例上呼吸道感染患者,将患者随机分为观察组和对照组,每组38例。对照组患者给予口服头孢氨苄治疗,观察组患者给予口服头孢克洛治疗,观察两组患者的临床症状、体征消失时间及临床疗效。结果观察组患者治疗后的临床症状及体征消失时间均少于对照组,差异有统计学意义（P 〈0. O5）。观察组患者治疗总有效率为92.1%,对照组为89.5%,两组比较差异无统计学意义（P 〉0. O5）。结论头孢克洛治疗上呼吸道感染临床疗效好,能够促进患者临床症状及体征的消失,值得临床进一步推广使用。     

A large scale, general practice based investigation into the clinical efficacy and tolerability of cefuroxime axetil in women with uncomplicated urinary tract infection

Female patients presenting to their general practitioner with symptoms of uncomplicated urinary tract infection (cystitis) were entered into one of three therapeutic trials in a study programme of cefuroxime axetil (125 mg twice daily or 250 mg twice daily) conducted throughout the United Kingdom. On entry to the study, demographic information, infection recurrence rate and clinical signs and symptoms were recorded and the patient given medication for 7-days' treatment. Post-treatment, clinical signs and symptoms were re-assessed and adverse event data collected. Of the 672 patients who entered the programme, 605 patients completed the course of treatment of whom 510 were taking the 125 mg and 95 taking the 250 mg dosage. No significant difference in clinical efficacy or adverse events was found between the two dosage regimens. Analysis of the changes in symptom severity from the pre-treatment to the post-treatment evaluation for all patients showed a highly significant improvement (p less than 0.001). One hundred and five (15.6%) of the patients who entered the study reported a total of 132 adverse events, 16 of whom were withdrawn from treatment. The most frequent event was diarrhoea/loose motions. This study shows that cefuroxime axetil appears to be effective and well-tolerated for the treatment of cystitis in general practice.     

A large scale,general practice based investigation into the clinical efficacy and tolerability of cefuroxime axetil in women with uncomplicated urinary tract infection

Summary

Female patients presenting to their general practitioner with symptoms of uncomplicated urinary tract infection (cystitis) were entered into one of three therapeutic trials in a study programme of cefuroxime axetil (12.5?mg twice daily or 2.50?mg twice daily) conducted throughout the United Kingdom. On entry to the study, demographic information, infection recurrence rate and clinical signs and symptoms were recorded and the patient given medication for 7-days' treatment. Post-treatment, clinical signs and symptoms were re-assessed and adverse event data collected. Of the 672 patients who entered the programme, 605 patient completed the course of treatment of whom 510 were taking the 12.5?mg and 95 taking the 250?mg dosage. No significant difference in clinical efficacy or adverse events was found between the two dosage regimens. Analysis of the changes in symptom severity from the pre-treatment to the post-treatment evaluation for all patients showed a highly significant improvement (p?0.001). One hundred and five (15.6%) of the patients who entered the study reported a total of 132 adverse events, 16 of whom were withdrawn from treatment. The most frequent event was diarrhoea/loose motions. This study shows that cefuroxime axetil appears to be effective and well-tolerated for the treatment of cystitis in general practice.     

炎琥宁与利巴韦林治疗小儿急性上呼吸道感染的疗效对比

目的比较炎琥宁与利巴韦林治疗小儿急性上呼吸道感染的临床疗效。方法将190例急性上呼吸道感染患儿随机分为治疗组和对照组各95例,分别采用炎琥宁和利巴韦林进行治疗,比较2组的临床疗效及临床症状/体征消退时间。结果治疗组总有效率为92.6%,高于对照组的73.7%,且临床症状/体征消退时间短于对照组,差异均有统计学意义(P<0.05和P<0.01)。结论炎琥宁治疗小儿急性上呼吸道感染的临床疗效显著优于利巴韦林。     

Influenza a common viral infection among Hajj pilgrims: time for routine surveillance and vaccination

BACKGROUND: The annual Hajj pilgrimage to Mecca, Saudi Arabia brings over two million people to a small confined area. Respiratory tract infection is the most common disease transmitted during this period. For most of the etiologic agents of upper respiratory tract infections, no vaccine or prophylaxis is available, except for influenza. Yearly influenza vaccination of high-risk groups is recommended, but no special recommendations are available for those performing the Hajj or other similar large congregational activities. Viral surveillance studies are being carried out through more than 100 centers around the world to identify newly emerging viruses. Saudi Arabia is not one of those centers and no routine surveillance takes place. METHODS: Five hundred Hajj pilgrims presenting with upper respiratory tract symptoms from different parts of the world were screened by way of a throat swab for viral culture, including influenza A and B, parainfluenza, respiratory syncytial virus (RSV), adenovirus, herpes simplex virus (HSV), and enteroviruses. Information was collected on age, sex, nationality, smoking habits and upper respiratory tract symptoms. Vaccination status for influenza and meningococcus was obtained by self-declaration, since most pilgrims did not have their vaccination cards with them. Only those with symptoms including at least fever, reported by the patient to be >38.3 degrees C, and/or sore throat were included. Pilgrims with any other symptoms, especially myalgia and fatigue alone, were excluded, since many of the physical chores during the pilgrimage may contribute to such symptoms. RESULTS: Fifty-four patients (10.8%) had positive viral throat cultures. Of these, 27 (50%) were influenza B, 13 (24.1%) were HSV, 7 (12.9%) were RSV, 4 (7.4%) were parainfluenza, and 3 (5.6%) were influenza A. No enteroviruses or adenoviruses were detected, and no multiple infections were detected. Only 22 (4.7%) pilgrims received the influenza vaccine. When the results are applied to the total number of pilgrims in 2003, an estimate of 24,000 cases of influenza is obtained. CONCLUSION: The findings from this study suggest a high incidence of influenza as a cause of upper respiratory tract infection among pilgrims, estimated to be 24,000 cases per Hajj season, excluding those becoming ill from contact with Hajj pilgrims returning home. They also indicate a very low vaccination rate for the influenza vaccine; as well as poor knowledge of its existence. Continued surveillance during the Hajj pilgrimage is necessary. The influenza vaccine should be a priority for those attending the Hajj pilgrimage, and should also be considered for antiviral prophylaxis.