This is the current release of the guideline.

All clinical reports and policy statements from the American Academy of Pediatrics automatically expire 5 years after publication unless reaffirmed, revised, or retired at or before that time.

Bacterial infections, including:

• Exposure to aerosolized Bacillus anthracis
• Urinary tract infections caused by Pseudomonas aeruginosa or other multidrug-resistant, Gram-negative bacteria
• Chronic suppurative otitis media or malignant otitis externa caused by P. aeruginosa
• Chronic or acute osteomyelitis or osteochondritis caused by P. aeruginosa
• Exacerbation of pulmonary disease in patients with cystic fibrosis (CF) who have colonization with P. aeruginosa
• Mycobacterial infections
• Gram-negative bacterial infections in immunocompromised hosts
• Gastrointestinal tract infection caused by multidrug-resistant Shigella species, Salmonella species, Vibrio cholerae, or Campylobacter jejuni
• Bacterial septicemia or meningitis

Assessment of Therapeutic Effectiveness
Management
Treatment

Family Practice
Infectious Diseases
Internal Medicine
Otolaryngology
Pediatrics
Pulmonary Medicine
Urology

Advanced Practice Nurses
Nurses
Physician Assistants
Physicians

To provide specific guidelines for the systemic use of fluoroquinolones in children

Patients younger than 18 years of age

Systemic fluoroquinolones

• Effectiveness of therapy
• Drug related adverse events
• Fluoroquinolone resistance

Searches of Electronic Databases

Not stated

Not stated

Weighting According to a Rating Scheme (Scheme Given)

Quality of Evidence

I: Evidence obtained from at least 1 properly randomized controlled trial

II-1: Evidence obtained from well-designed controlled trials without randomization

II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than1 center or research group

II-3: Evidence obtained from multiple time series with or without the intervention; dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence

III: Opinions of respected authorities that are based on clinical experience, descriptive studies, and case reports or reports of expert committees

Review

Not stated

Expert Consensus

Not stated

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

Peer Review

Not stated

The levels of evidence (I-III) are defined at the end of the "Major Recommendations" field.

Recommendations

The inappropriate use of fluoroquinolones in children and adults is likely to be associated with increasing bacterial resistance to these agents.

The use of fluoroquinolone in a child or adolescent may be justified in special circumstances after careful assessment of the risks and benefits for the individual patient. Although there is no compelling evidence supporting the occurrence of sustained injury to developing joints in humans by a fluoroquinolone, the possibility that it occurs infrequently has not been excluded.

Circumstances in which fluoroquinolones may be useful include those in which (1) infection is caused by multidrug-resistant pathogens for which there is no safe and effective alternative and (2) parenteral therapy is not feasible and no other effective oral agent is available. Appropriate uses should be limited to the following:

• Exposure to aerosolized Bacillus anthracis to decrease the incidence or progression of disease (FDA licensed) (evidence grade III)
• Urinary tract infections caused by Pseudomonas aeruginosa (P. aeruginosa) or other multidrug-resistant, Gram-negative bacteria (FDA licensed for complicated Escherichia coli urinary tract infections and pyelonephritis attributable to Escherichia coli in patients 1 to 17 years of age) (evidence grade II-2)
• Chronic suppurative otitis media or malignant otitis externa caused by P. aeruginosa (evidence grade II-3)
• Chronic or acute osteomyelitis or osteochondritis caused by P. aeruginosa (not for prophylaxis of nail puncture wounds to the foot) (evidence grade III)
• Exacerbation of pulmonary disease in patients with cystic fibrosis (CF) who have colonization with P. aeruginosa and can be treated in an ambulatory setting (evidence grade II-2)
• Mycobacterial infections caused by isolates known to be susceptible to fluoroquinolones (evidence grade III)
• Gram-negative bacterial infections in immunocompromised hosts in which oral therapy is desired or resistance to alternative agents is present (evidence grade II-1)
• Gastrointestinal tract infection caused by multidrug-resistant Shigella species, Salmonella species, Vibrio cholerae or Campylobacter jejuni (evidence grade II-2)
• Documented bacterial septicemia or meningitis attributable to organisms with in vitro resistance to approved agents or in immunocompromised infants and children in whom parenteral therapy with other appropriate antimicrobial agents has failed (evidence grade III)
• Serious infections attributable to fluoroquinolones-susceptible pathogens(s) in children with life-threatening allergy to alternative agents (evidence grade III)

Definitions:

Quality of Evidence

I: Evidence obtained from at least 1 properly randomized controlled trial

II-1: Evidence obtained from well-designed controlled trials without randomization

II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than1 center or research group

II-3: Evidence obtained from multiple time series with or without the intervention; dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence

III: Opinions of respected authorities that are based on clinical experience, descriptive studies, and case reports or reports of expert committees

None provided

The type of evidence is identified and graded for each recommendation (see "Major Recommendations").

Appropriate use of fluoroquinolone use in children and adolescents

• The inappropriate use of fluoroquinolones in children and adults is likely to be associated with increasing bacterial resistance to these agents.
• Fluoroquinolones cause arthrotoxicity in juvenile animals and have been associated with reversible musculoskeletal events in both children and adults. Other adverse events associated with fluoroquinolones include central nervous system disorders, photosensitivity, disorders of glucose homeostasis, prolongation of QT interval with rare cases of torsade de pointes (often lethal ventricular arrhythmia in patients with long QT syndrome), hepatic dysfunction, and rashes.

An implementation strategy was not provided.

Getting Better
Living with Illness

Effectiveness
Safety

Not applicable: The guideline was not adapted from another source.

2006 Sep

American Academy of Pediatrics - Medical Specialty Society

American Academy of Pediatrics

Committee on Infectious Diseases

Committee on Infectious Diseases, 2004-2005: Keith R. Powell, MD, Chairperson; Robert S. Baltimore, MD; Henry Bernstein, DO; Joseph A. Bocchini, Jr, MD; John S. Bradley, MD; Michael Brady, MD; Penelope H. Dennehy, MD; Robert W. Frenck, Jr, MD; David Kimberlin, MD; Sarah S. Long, MD; Julia A. McMillan, MD; Lorry G. Rubin, MD

Past Committee Members: Carol J. Baker, MD; Caroline B. Hall, MD; H. Cody Meissner, MD; Margaret B. Rennels, MD

Liaisons: Richard D. Clover, MD, American Academy of Family Physicians; Steven Cochi, MD, Centers for Disease Control and Prevention; Joanne Embree, MD, Canadian Paediatric Society; Marc A. Fischer, MD, Centers for Disease Control and Prevention; Benjamin Schwartz, MD, National Vaccine Program Office; Mamodikoe Makhene, MD, National Institutes of Health; Douglas Pratt, MD, Food and Drug Administration; Jeffrey R. Starke, MD, American Thoracic Society; Jack Swanson, MD, Practice Action Group

Ex Officio: Larry K. Pickering, MD, Red Book Editor

Consultant: Edgar O. Ledbetter, MD

Staff: Alison Siwek, MPH

Committee on Infectious Diseases, 2003-2004: Margaret B. Rennels, MD, Chairperson; H. Cody Meissner, MD, Vice Chairperson; Carol J. Baker, MD; Robert S. Baltimore, MD; Joseph A. Bocchini, Jr, MD; John S. Bradley, MD; Penelope H. Dennehy, MD; Robert W. Frenck, Jr, MD; Caroline B. Hall, MD; Sarah S. Long, MD; Julia A. McMillan, MD; *Keith R. Powell, MD; Lorry G. Rubin, MD; Thomas N. Saari, MD

Liaisons: Richard D. Clover, MD, American Academy of Family Physicians; Steven Cochi, MD, Centers for Disease Control and Prevention; Joanne Embree, MD, Canadian Paediatric Society; Marc Fischer, MD, Centers for Disease Control and Prevention; Bruce Gellin, MD, MPH, National Vaccine Program Office; Mamodikoe Makhene, MD, National Institutes of Health; Douglas Pratt, MD, Food and Drug Administration; Jeffrey R. Starke, MD, American Thoracic Society

Ex Officio: Larry K. Pickering, MD, Red Book Editor

Staff: Martha Cook, MS

* Lead author

Not stated

This is the current release of the guideline.

All clinical reports and policy statements from the American Academy of Pediatrics automatically expire 5 years after publication unless reaffirmed, revised, or retired at or before that time.

None available

None available

This NGC summary was completed by ECRI on December 7, 2006. The information was verified by the guideline developer on December 22, 2006. This summary was updated by ECRI Institute on July 28, 2008 following the U.S. Food and Drug Administration advisory on fluoroquinolone antimicrobial drugs.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. Please contact the Permissions Editor, American Academy of Pediatrics (AAP), 141 Northwest Point Blvd, Elk Grove Village, IL 60007.