The FDA has approved Exblifep (Allecra), a fixed-dose combination of the cephalosporin cefepime and the beta-lactamase inhibitor enmetazobactam, for IV treatment of adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by designated susceptible microorganisms (see Spectrum of Activity). Exblifep is the first product that contains enmetazobactam to be approved in the US.

Since 2007, antimicrobial prophylaxis for dental procedures has been recommended to prevent viridans group streptococcal infective endocarditis only for patients at highest risk of an adverse outcome. Limiting use to such patients does not appear to have led to an increased incidence of infective endocarditis or increased mortality due to infective endocarditis.

Most respiratory tract infections are caused by viruses. Bacterial respiratory tract infections are usually treated empirically with antibiotic therapy that targets the most probable causative pathogens. Recommended antibiotic regimens for outpatient treatment of some common respiratory tract infections are listed in Table 1 for adults and Table 2 for children.

This article includes recommendations for management of most sexually transmitted infections (STIs) other than HIV and viral hepatitis. Some of the indications and dosages recommended here have not been approved by the FDA (see Table 1).

More antibiotics are prescribed for treatment of acute otitis media (AOM) than for any other infection in young children. Children with AOM typically present with otalgia, fever, and bulging and erythema of the tympanic membrane.

Lyme disease in the US is caused by the spirochete Borrelia burgdorferi, which is transmitted to humans by Ixodes scapularis (blacklegged [deer] tick) and I. pacificus (western blacklegged tick). Most cases of Lyme disease occur in late spring and early summer in northeastern and mid-Atlantic states, the upper Midwest, and in northern California. B. mayonii, which is also transmitted by I. scapularis, has been shown to cause a similar illness in the upper Midwest.

The CDC has issued new recommendations for treatment of gonococcal infection. A single 500-mg IM dose (1000 mg in patients weighing ≥150 kg) of the third-generation cephalosporin ceftriaxone is now the treatment of choice for patients with uncomplicated urogenital, rectal, or pharyngeal gonorrhea.

Treatment of community-acquired pneumonia (CAP) is usually empiric, with selected antibiotic regimens directed against some of the most common causative pathogens. Recommended empiric regimens are listed in Table 2; recommended antibiotic dosages for treatment of CAP are listed in Tables 3 and 4. Joint guidelines for treatment of CAP by the American Thoracic Society and the Infectious Diseases Society of America (ATS/IDSA) were updated in 2019.

The FDA has approved cefiderocol (Fetroja – Shionogi), a new IV cephalosporin antibiotic, for treatment of complicated urinary tract infections (UTI) caused by susceptible gram-negative bacteria in adults who have limited or no alternative treatment options.

Lefamulin (Xenleta – Nabriva), a semisynthetic pleuromutilin antibiotic, has been approved by the FDA for IV and oral treatment of community-acquired bacterial pneumonia (CABP) in adults. It is the first systemic pleuromutilin antibiotic to be approved in the US; retapamulin (Altabax), a 1% topical ointment for treatment of impetigo, was approved in 2007.

The FDA has approved omadacycline (Nuzyra – Paratek), a semisynthetic tetracycline derivative, for once-daily IV and oral treatment of community-acquired bacterial pneumonia (CAP) and acute bacterial skin and skin structure infections (ABSSSIs) in adults.

Eravacycline (Xerava – Tetraphase), a new synthetic tetracycline antibiotic, has been approved by the FDA for IV treatment of complicated intra-abdominal infections (cIAIs) in adults. Eravacycline is structurally similar to tigecycline (Tygacil, and generics), a broad-spectrum tetracycline approved by the FDA for IV treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired pneumonia. A higher rate of mortality has been reported with use of tigecycline compared to other antibacterial drugs; it should be used only when no suitable alternative is available.

The FDA has approved the new aminoglycoside antibiotic plazomicin (Zemdri – Achaogen) for IV treatment of adults with complicated urinary tract infections (cUTIs). Plazomicin is active against multi-drug- resistant Enterobacteriaceae, including strains resistant to other aminoglycosides.

The FDA has approved a fixed-dose combination of meropenem, a carbapenem antibiotic, and vaborbactam, a new beta-lactamase inhibitor (Vabomere – Melinta), for IV treatment of adults with complicated urinary tract infections (UTIs) that are proven or strongly suspected to be caused by Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae spp. complex. Meropenem (Merrem, and generics) has been approved for years for treatment of complicated skin and skin structure infections, intra-abdominal infections, and bacterial meningitis. Resistance to meropenem and other carbapenems, mainly due to production of carbapenemases and other extended-spectrum beta-lactamases (ESBLs), has been increasing worldwide, particularly among Enterobacteriaceae. Vabomere is the first carbapenem/beta-lactamase inhibitor combination to be marketed in the US.

The FDA has approved delafloxacin (Baxdela – Melinta), an anionic fluoroquinolone antibiotic, for oral and parenteral treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant Staphylococcus aureus (MRSA). It is the first fluoroquinolone to be approved for treatment of MRSA.

Bacterial infections in adults are generally treated empirically, with the antibiotic covering most, but not all, of the potential causative pathogens. For some infections, culture and sensitivity testing can guide treatment, allowing for use of narrower-spectrum antibiotics. The recommended dosages and durations of antibiotic treatment for common respiratory, skin, and urinary tract infections are listed in Tables 1-3. Infectious disease experts now recommend shorter treatment durations for many infections to reduce the development of antimicrobial resistance and minimize adverse effects.

The text and tables that follow include recommendations for management of sexually transmitted infections (STIs) other than HIV and viral hepatitis. Some of the indications and dosages recommended here have not been approved by the FDA.

Antimicrobial prophylaxis can decrease the incidence of postoperative surgical site infection after some procedures. Since the last Medical Letter article on this subject, consensus guidelines have been published. Recommendations for prophylaxis in specific surgical procedures are listed in Table 1.

Most cases of Lyme disease in the US occur between May and September in the Northeastern, Mid-Atlantic, and North Central states.

The FDA has approved ceftazidime/avibactam (Avycaz – Actavis) for IV treatment of complicated urinary tract and intra-abdominal infections in adults who have limited or no other treatment options. Ceftolozane/tazobactam (Zerbaxa – Cubist), another cephalosporin/beta-lactamase inhibitor combination, was approved in 2014.

The FDA has approved ceftolozane/tazobactam (Zerbaxa – Cubist), a combination of a new cephalosporin antibiotic and a beta-lactamase inhibitor, for intravenous treatment of complicated urinary tract and intra-abdominal infections in adults.

The FDA has approved oritavancin (Orbactiv – The Medicines Company), a long-acting lipoglycopeptide antibiotic given as a single intravenous (IV) dose, for treatment of acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria in adults. It is the third lipoglycopeptide antibiotic to be marketed in the US; telavancin (Vibativ) and dalbavancin (Dalvance) were approved earlier.

The treatment of atrial fibrillation includes anticoagulation, rate control, and rhythm control. New US guidelines for the management of atrial fibrillation have recently been published.

An outbreak (8 cases to date) of meningococcal disease at Princeton University caused by Neisseria meningitidis serogroup B has led the FDA and CDC to permit importation and investigational use (at Princeton University only) of a meningococcus B vaccine (4CMenB; Bexsero – Novartis) that has not been approved in the US. Bexsero has been approved for use in the European Union and in Australia.

THE VACCINE — Until recently, no serogroup B vaccine was widely available because the polysaccharide capsule of the B serogroup, unlike those of the other main meningococcal serogroups (A, C, Y, and W-135), is only weakly immunogenic. The 4CMenB vaccine contains 3 protein antigens identified in the N. meningitidis serogroup B genome and membrane components from a New Zealand outbreak strain. The vaccine has been tested in more than 8000 adults and children, has proved to be immunogenic, and appears to be safe.1 Its efficacy has not been established clinically, but laboratory testing, according to the CDC, has found that the vaccine should be protective against the strain causing the Princeton University outbreak. Bactericidal antibody levels develop about 2 weeks after one dose of the vaccine; a second dose is needed 1-6 months after the first to maintain protection.

CHEMOPROPHYLAXIS — Close contacts of patients with invasive meningococcal disease (e.g., same household, roommates, boyfriend or girlfriend) should receive antimicrobial chemoprophylaxis. Antimicrobial drugs can prevent secondary cases and eradicate the organism from the nasopharynx of healthy carriers. The susceptibility of serogroup B meningococci to antimicrobial agents is the same as that of other meningococcal serogroups. Regimens recommended by the CDC’s Advisory Committee on Immunization Practices are: oral rifampin 600 mg (10 mg/kg for children) q12h for 2 days; oral ciprofloxacin 500 mg once (not recommended for children); or a single IM injection of ceftriaxone 250 mg (125 mg for children).2

CONCLUSION — The new vaccine against serogroup B meningococcal disease, which is investigational in the US, appears to be immunogenic and safe. For immediate protection after close contact with an infected patient, antimicrobial prophylaxis is recommended.

1. NJ Carter. Multicomponent meningococcal serogroup B vaccine (4CMenB; Bexsero®): a review of its use in primary and booster vaccination. BioDrugs 2013; 27:263.

2. AC Cohn et al. Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2013; 62(RR-2):1.

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Many infections can be transmitted during sexual contact. The text and tables that follow include recommendations for management of sexually transmitted infections (STIs) other than HIV, viral hepatitis, and enteric infections. Some of the indications and dosages recommended here have not been approved by the FDA.

The text that follows reviews some common bacterial infections and their empiric treatment pending the results of culture and susceptibility testing. The recommendations made here are based on the results of susceptibility studies, clinical trials, and the opinions of Medical Letter reviewers. Tables 1 and 2 list the usual dosages of antibacterial drugs.

Antimicrobial prophylaxis can decrease the incidence of postoperative infection, particularly surgical site infection, after some procedures. Recommendations for such prophylaxis are listed in the table that begins on page 74. Antimicrobial prophylaxis for dental procedures to prevent endocarditis was recently discussed in The Medical Letter.

The most recent guidelines from the Infectious Diseases Society of America (IDSA) and its European counterpart on the choice of antimicrobials for treatment of uncomplicated urinary tract infections (UTIs) in non-pregnant women focus on the unnecessary use of fluoroquinolones to treat uropathogens that are increasingly becoming resistant to them. Resistance of Escherichia coli to ciprofloxacin in the US has increased from 3% in 2000 to 17.1% in 2010.

The FDA has approved ceftaroline fosamil (Teflaro – Forest), an intravenous (IV) cephalosporin, for treatment of acute bacterial skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA), and for treatment of community-acquired bacterial pneumonia in adults. It is the first beta-lactam antibiotic approved for treatment of MRSA.

Most cases of Lyme disease in the US occur between May and September in the Northeastern, Mid-Atlantic and North Central states.

Many infections can be transmitted during sexual contact. The text and tables that follow are limited to management of sexually transmitted infections (STIs) other than HIV, viral hepatitis and enteric infections. The drugs of choice, their dosages and alternatives are listed in a table that begins on page 54. A table listing the adverse effects of some of these antimicrobials begins on page 58.

The text below reviews some common bacterial infections and their treatment. The recommendations made here are based on the results of susceptibility studies, clinical trials and the opinions of Medical Letter consultants.

Some readers have asked why the June 2009 issue of Treatment Guidelines (Antimicrobial Prophylaxis for Surgery) did not recommend use of ertapenem (Invanz) for prevention of infection after elective colorectal surgery. Ertapenem is a broad-spectrum carbapenem that has been approved for such use by the FDA. Medical Letter consultants do not recommend use of broad-spectrum drugs such as ertapenem, third-generation cephalosporins such as cefotaxime (Claforan), ceftriaxone (Rocephin), cefoperazone (Cefobid), ceftazidime (Fortaz, and others) or ceftizoxime (Cefizox), or fourth-generation cephalosporins such as cefepime (Maxipime) for routine surgical prophylaxis because they are expensive, some are less active than first- or second-generation cephalosporins against staphylococci, and their spectrum of activity includes organisms rarely encountered in elective surgery. These drugs should be reserved for treatment of serious infections, particularly those likely to be caused by organisms resistant to other antimicrobials.

The CDC recently reported that fluoroquinoloneresistant strains of Neisseria meningitidis have been detected for the first time in the US in an area around the border of North Dakota and Minnesota (CDC. MMWR, Feb 22, 2008). These isolates were all serogroup B, for which meningococcal vaccines (Med Lett Drugs Ther 2005; 47:29) do not offer protection. Since many laboratories do not test N. meningitidis for antimicrobial susceptibility, it is possible that such resistance is more widespread.

A single oral dose of ciprofloxacin (Cipro, and others) 500 mg has been used for prophylaxis after close contact with infected patients. Oral rifampin (Rifadin, and others) 600 mg (10 mg/kg for children) q12h for 2 days, a single IM injection of ceftriaxone (Rocephin, and others) 250 mg (125 mg for children), or a single oral dose of azithromycin (Zithromax, and others) 500 mg (10 mg/kg for children) are reasonable alternatives.

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On page 100 of the article "Major Changes in Endocarditis Prophylaxis for Dental, GI and GU Procedures", under the section Highest-Risk Procedures, the word "rubber" should have been omitted. Placement of orthodontic rubber bands is not a highest-risk procedure that justifies prophylaxis; placement of orthodontic (metal) bands is. An orthodontic band is a metal ring that surrounds the tooth and is pressed into place causing movement in closely-spaced teeth and sometimes bleeding when the bands are placed close to the gumline.

The American Heart Association has issued its revised guidelines for prevention of infective endocarditis. Antimicrobial prophylaxis for dental procedures is now recommended only for patients at the highest risk of severe consequences from endocarditis who are undergoing the highest-risk procedures. Endocarditis prophylaxis is no longer recommended for gastrointestinal (GI) and genitourinary (GU) procedures. When these changes are implemented, the number of patients receiving antimicrobial prophylaxis to prevent endocarditis should decline sharply.

Many infections can be transmitted during sexual contact. The text and tables that follow are limited to management of sexually transmitted infections (STIs) other than HIV, viral hepatitis and enteric infections. Guidelines are available from the US Centers for Disease Control and Prevention (CDC) with detailed recommendations for treatment of these diseases.

Information about empirical treatment of bacterial infections, emerging trends in antimicrobial resistance, new drugs and new data about older drugs continue to become available. Usual pathogens and empiric treatment for some common types of infections are summarized in the text and a table listing the drugs of choice and alternatives for each pathogen begins on page 40. The recommendations made here are based on the results of susceptibility studies, clinical trials and the opinions of Medical Letter consultants.

Lyme disease in North America is caused by the spirochete Borrelia burgdorferi, which is transmitted to humans by Ixodes scapularis or pacificus ticks. These ticks may also carry other pathogens; coinfection with Babesia microti or Anaplasma phagocytophilum (formerly Ehrlichia) has been reported.1 In 2001 and 2002, 12 states (CT, DE, ME, MD, MA, MI, NH, NJ, NY, PA, RI, WI) reported about 95% of all the Lyme disease in the US, but cases occurred in all states except HI, MT and OK. Most Lyme disease in North America occurs between May and September.

Many infections can be transmitted during sexual contact. The text and tables that follow are limited to management of sexually transmitted infections (STIs) other than HIV, viral hepatitis and enteric infections. Guidelines are available from the US Centers for Disease Control and Prevention (CDC) with detailed recommendations for treatment of these diseases (MMWR Recomm Rep 2002; 51, RR-6:1). New guidelines are expected soon.

Antimicrobial prophylaxis can decrease the incidence of infection, particularly surgical site infection, after certain operations, but this benefit must be weighed against the risks of toxic and allergic reactions, emergence of resistant bacteria, adverse drug interactions, superinfection and cost. Medical Letter consultants generally recommend antimicrobial prophylaxis only for procedures with high infection rates, those involving implantation of prosthetic material, and those in which the consequences of infection are likely to be especially serious.

New drugs for bacterial infections and new information about older drugs continue to become available. Empirical treatment of some common bacterial infections is discussed in this article. A table listing the drugs of choice and alternatives for each pathogen begins on page 18. These recommendations are based on results of susceptibility studies, clinical trials and the opinions of Medical Letter consultants. Local resistance patterns should be taken into account. Trade names are listed on page 24.

Daptomycin (Cubicin - Cubist), a cyclic lipopeptide (a new class of antibiotics), has been approved by the FDA for intravenous (IV) treatment of complicated skin and skin structure infections. It is being promoted as a once-daily bactericidal alternative to vancomycin (Vancocin, and others) for methicillin-resistant Staphylococcus aureusinfections.

The choice of drugs for treatment of pneumonia depends on the most likely pathogens causing the infection and local antimicrobial resistance patterns. Factors such as severity of illness, presence of co-morbid conditions and whether the infection is community or hospital-acquired also need to be considered.

Immune-mediated hemolysis is a rare adverse effect of second- and third-generation cephalosporins, especially cefotetan (Cefotan) (PA Arndt et al, Transfusion 1999; 39:1239). A recent report serves as a reminder that life-threatening immune-mediated hemolysis rarely can follow administration of ceftriaxone (Rocephin), one of the most commonly used parenteral antibiotics in the US (A Citak et al, J Paediatr Child Health 2002; 38:209).

Ertapenem (er ta pen' em; Invanz - Merck), a carbapenem antibacterial with a narrower spectrum of activity than imipenem (Primaxin) or meropenem (Merrem), has been approved by the FDA for once-daily IV treatment of complicated intra-abdominal, urinary tract and skin and skin structure infections, acute pelvic infections, and community-acquired pneumonia.

Lyme disease is caused by the spirochete Borrelia burgdorferi and transmitted to humans by Ixodes ticks. These ticks may also carry other pathogens; co-transmission of Babesia and Ehrlichia species has been reported.

Gatifloxacin and moxifloxacin are now available for once-daily treatment of patients with community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, or acute sinusitis.

Many infections can be transmitted during sexual contact. The text and tables [in this article] are limited to treatment of non-HIV infections associated primarily with sexual transmission.

Lyme disease, a multisystem infection transmitted by ixodid ticks and caused by the spirochete Borrelia burgdorferi is the most common vector-borne illness in the USA. Cases have been reported in 44 states, and also in Canada and many countries in Europe and Asia (ME Falagas and SL Gorbach, Infect Dis Clin Pract, 5:217, 1996).

Sparfloxacin (Zagam - Rh ne-Poulenc Rorer) and levofloxacin (Levaquin - Ortho-McNeil) are the newest fluoroquinolone antimicrobials to be approved by the US Food and Drug Administration. Sparfloxacin in a once-daily oral preparation is being marketed for treatment of community-acquired pneumonia and acute bacterial exacerbations of chronic bronchitis. Levofloxacin, which is the active stereoisomer of ofloxacin (Floxin), is available for either oral or parenteral use; it is approved for oncedaily treatment of community-acquired pneumonia, acute exacerbations of chronic bronchitis, sinusitis, skin and skin structure infections and complicated urinary tract infections.

Meropenem (Merrem - Zeneca), a carbapenem similar to imipenem-cilastatin (Primaxin), has been approved by the US Food and Drug Administration for intravenous (IV) treatment of complicated intra-abdominal infections in adults and children and bacterial meningitis in children more than three months old. Imipenem (Medical Letter, 28:29, 1986) has been useful for treatment of serious infections in which broad coverage of nosocomial organisms, including anaerobes, is needed. Other drugs for these indications were reviewed in the Medical Letter article on 'The Choice of Antibacterial Drugs' (volume 38, page 25, March 29, 1996).

Cefepime hydrochloride (Maxipime - Bristol-Myers Squibb), a new 'fourth-generation' cephalosporin, has been approved by the US Food and Drug Administration (FDA) for parenteral treatment of urinary tract infections and skin and skin-structure infections due to susceptible pathogens, and for moderate to severe pneunmonia caused by Streptococcus pneumoniae (pneumococci), Pseudomonas aeruginosa, Enterobacter or Klebsiella pneumoniae.

Results of recently completed clinical trials have led to some changes in recommendation for treatment of human immunodeficiency virus (HIV) and other infections associated with AIDS.

Piperacillin/tazobactam (Zosyn - Lederle), an antibiotic combination product, has been approved by the US Food and Drug Administration for intravenous treatment of intra-abdominal, pelvic, skin, and skin-structure infections and for community-acquired pneumonia of moderate severity.

Cefpodoxime proxetil (Vantin - Upjohn), a new third-generation oral cephalosporin, has been approved for marketing by the US Food and Drug Administration. It is available for twice-daily treatment of pharyngitis, upper and lower respiratory infections, otitis media, urinary tract infections, skin and soft tissue infections, and for single-dose treatment of uncomplicated gonorrhea in men or women and anorectal gonorrhea in women.

Enoxacin (en ox' a sin; Penetrex - Rh ne-Poulenc Rorer), a fluoroquinolone antimicrobial for oral use, has now been marketed in the USA for treatment of urinary tract infections and uncomplicated urethral or cervical gonorrhea.

Lyme disease, a multisystem infection transmitted by ixodid ticks and caused by the spirochete Borrelia burgdorferi the most common vector-borne illness in the USA. It occurs, mainly in the northeast, upper midwest, and California, but cases have been reported in 48 states, and also in Canada and many countries in Europe.

A growing number of clinical trials now permits some consensus on the treatment of human immunodeficiency virus (HIV) and other infections associated with acquired immune deficiency syndrome (AIDS) in adults.

Ciprofloxacin, previously available orally (Cipro - Medical Letter, 30:11, 1988) and for ophthalmic use (Ciloxan - Medical Letter, 33:52, May 31, 1991), is now the first fluoroquinolone antibiotic to become available in the USA in an intravenous (IV) formulation. Cipro I.V. (Miles) is being promoted as an alternative to third-generation cephalosporins, aminoglycosides, and other drugs used for treatment of serious infections.

Ofloxacin (Floxin - McNeil, Ortho), a new fluoroquinolone antibacterial agent, was recently marketed in the USA for oral treatment of various infections caused by susceptible microorganisms. Ofloxacin is the third fluoroquinolone to become available in this country. Norfloxacin (Noroxin - Medical Letter, 29:25, 1987) is marketed only for treatment of urinary tract infections. Ciprofloxacin (Cipro - Medical Letter, 30:11, 1988), like ofloxacin, is approved for use in a variety of infections.

Cefixime (Suprax - Lederle), an oral cephalosporin antibiotic, was recently approved for marketing by the US Food and Drug Administration. Claimed to be the first oral third-generation cephalosporin, the new drug is offered for once-a-day treatment of otitis media, pharyngitis, bronchitis and urinary tract infections.

Lyme disease, a multisystem bacterial transmitted by Ixodid ticks, particularly in early summer, continues to be a common problem in the USA and many other countries. Since last year (Medical Letter, 30:65, 1988), some new information has become available, but data on the choice, dosage and duration of antibiotic therapy are still available, but data on the choice, dosage and duration of antibiotic therapy are still limited.

A recent report in the New England Journal of Medicine suggested that in children with bacterial meningitis, adding the corticosteroid dexamethasone (Decadron; and others) to antibiotic treatment could decrease the incidence of moderate or severe hearing loss.

A penicillin is the drug of choice for treatment of many infections, but allergic reactions to these drugs occur frequently and, rarely, can be fatal. From 5% to 20% of patients have a history of a rash or some other reaction while taking a penicillin, but maculopapular rashes with ampicillin or amoxicillin, especially in children with infectious mononucleosis, are probably not allergic.

Lyme Disease, a multisystem inflammatory disorder transmitted by lxodid ticks and caused by the spirochete Borrelia burgdorferi, is now the most common tick-transmitted illness in the USA. It has been reported in 32 states and on all other continents except Antarctica. Infected ticks have been found not only in wooded areas, but also on well-maintained suburban lawns (RC Falco and D Fish, Am J Epidemiol, 127:826, April 1988). Optimal treatment for this newly discovered disease is still being determined, but some recommendations based on published experience and work in progress can be made.