Community-acquired pneumonia is a leading cause of sickness (morbidity) and death (mortality) due to an infectious disease in children. Four (4)bacteria are important causes of these infections in children and in adults. Although levofloxacin is a highly effective and safe treatment for community-acquired pneumonia in adults, it has not been used extensively in children with community-acquired pneumonia. There is a concern about the safety of this agent because it is observed that young laboratory animals given single high doses of this drug may develop abnormalities in the soft tissue of the weight bearing joints. However, the experience over the past years with use of this drug to treat children with a variety of serious infectious diseases suggests that the adverse events associated with levofloxacin in children are similar to those reported in adults. Opinions expressed by experts in the field of pediatric diseases suggest that this class of drugs have been used safely to treat children and should be considered as an option or another choice of therapy in serious contagious diseases.

The purpose of this study is to compare the effectiveness and safety of levofloxacin for the treatment of community-acquired pneumonia in infants, children, and adolescents (age 6 months to 16 years) to the usual medications used to treat this disease. Because the pathogens that cause community-acquired pneumonia in children are identical to those that cause community-acquired pneumonia in adults, the dosing regimens of levofloxacin in children were chosen to achieve similar blood levels that occur with a currently recommended dose to treat community-acquired pneumonia in adults (500 mg once daily for 7 to 14 days).

Condition	Treatment or Intervention
Pneumonia	Drug: Levofloxacin tablet, suspension or intravenous  Drug: Ceftriaxone intravenous  Drug: Amoxicillin/clavulanate suspension  Drug: Erythromycin intravenous  Drug: Clarithromycin suspension or tablets

Further Study Details: 

Expected Total Enrollment:  650

Ages Eligible for Study:  6 Months   -   16 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Subjects must satisfy the following criteria before entering the study:

1. 6 months to 16 years, inclusive;

2. Signs and symptoms of pneumonia, including at least 2 of the following:

• fever ;
• cough;
• chest pain;
• shortness of breath;
• evidence of pulmonary consolidation on physical examination;
• White blood cell (WBC) count >15,000/uL or <5000/uL.

3. Chest x-ray showing evidence of pulmonary infiltrate;

4. Production of sputum;

• Note: Sputum production is not an absolute requirement for enrollment, however all reasonable attempts to obtain a sputum specimen should be made.

5. If female:

• she must be incapable of pregnancy, or
• have practiced 1 of the following methods of contraception for at least 1 month prior to study entry and agree to continue the same method during the study: hormonal contraceptives, intrauterine device, spermicide and barrier, spousal/partner sterility, or abstinence.

6. If a female subject is capable of becoming pregnant and is practicing an acceptable method of birth control, she must have a negative serum pregnancy test within 24 hours before study drug administration. To avoid delay in treatment, subjects may enter on the basis of a urine pregnancy test sensitive to at least 50 mIU/mL pending results of serum test. If the serum test is positive the subject must be discontinued;

7. Subject's parent(s) or legal guardian(s) must read and sign the informed consent form (and sign other locally required documents) after the nature of the study has been fully explained and assent must be obtained from subjects capable of understanding the nature of the study,

8. Must not have participated in an experimental drug or experimental medical device trial within 30 days prior to the planned start of treatment.

Exclusion Criteria

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Use of systemic antibiotics for more than 24 hours immediately prior to enrollment;

2. Requires use of systemic antibiotic therapy other than study drug(s);

3. Suspected infection with microorganisms (virus, fungi, parasites or bacteria) known to be resistant to levofloxacin,or the other study drugs;

4. Signs and symptoms of a bacterial infection of the central nervous system;

5. History of a previous hypersensitivity or serious adverse reaction against any quinolone, macrolide, beta-lactam, cephalosporin, or clavulanic acid;

6. History of cystic fibrosis;

7. Abnormal renal function;

8. History or presence of arthropathy or periarticular disease or any other musculoskeletal signs or symptoms that in the opinion of the investigator may confound a future safety evaluation of musculoskeletal complaints;

9. High probability of death during the study;

10. Hospitalization or residence in a long-term care facility for 14 or more days before the onset of symptoms;

11. Infection acquired in a hospital;

12. Previous participation in this protocol or another levofloxacin clinical study;

13. Seizure disorder that is poorly controlled (e.g., a seizure in the past 6 months or more than 2 seizures in the past year) or at significant risk for seizures (e.g., recent serious head trauma);

14. Unstable psychiatric disorder;

15. Known or highly suspected to have infection with Mycobacterium tuberculosis;

16. Known HIV infection requiring pneumocystis carinii pneumonia (PCP) prophylaxis;

17. Chronic use of corticosteroids;

18. Pregnant or nursing females;

19. Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center. Family members are also excluded

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35233,  United States
      Southern Drug Research Network, Tallassee,  Alabama,  36078,  United States
Arizona
      Maricopa Medical Center, Phoenix,  Arizona,  85008,  United States
      Scottsdale Healthcare, Scottsdale,  Arizona,  85260-6709,  United States
      Phoenix Children's Hospital, Phoenix,  Arizona,  85016-7710,  United States
California
      Children's Hospital of Orange County, Orange County,  California,  92868,  United States
      Children's Hospital Oakland, Oakland,  California,  94609-1809,  United States
      Children's Hsopital - San Diego, San Diego,  California,  92123,  United States
      Children's Hospital Los Angeles, Los Angeles,  California,  90027,  United States
      Madera Family Medical Group, Madera,  California,  93637,  United States
      Peninsula Research Associates, Inc., Rolling Hills Estates,  California,  90274,  United States
      Center for Clinical Trials of San Gabriel, West Covina,  California,  91790,  United States
Colorado
      Child First Pediatrics, Englewood,  Colorado,  80112,  United States
Connecticut
      Stamford Hospital, Stamford,  Connecticut,  06902,  United States
Florida
      Tampa General Hospital, Tampa,  Florida,  33606,  United States
      University of Florida, Jacksonville,  Florida,  32209-6511,  United States
      Joe DiMaggio children's Hospital, Hollywood,  Florida,  33021,  United States
      Chiefland Medical Center, Chiefland,  Florida,  32626,  United States
Georgia
      Raymond Tidman, MD, Blue Ridge,  Georgia,  30512,  United States
Idaho
      St. Luke's Children's Specialty Center, Boise,  Idaho,  83712,  United States
Illinois
      Georgia Clinical Professionals Group, Chicago,  Illinois,  30909,  United States
      Mount Sinai Hospital, Chicago,  Illinois,  60608,  United States
Kentucky
      Kentucky Pediatric/Adult Research, Bardstown,  Kentucky,  40004,  United States
Louisiana
      Bocchini, Joseph, Shreveport,  Louisiana,  71130,  United States
      Steele, Russell, New Orleans,  Louisiana,  70118,  United States
      Paragon Health Services, Slidell,  Louisiana,  70458,  United States
      Lakeside Children's Clinic, Metairie,  Louisiana,  70001,  United States
      Ochsner Clinical Foundation, New Orleans,  Louisiana,  70121,  United States
Massachusetts
      Maxwell Finland Laboratory for Infectious Disease, Boston,  Massachusetts,  02118,  United States
Michigan
      Comstock, Barton, Stevensville,  Michigan,  49127,  United States
      Children's Hospital of Michigan, Detroit,  Michigan,  48201,  United States
      William Beaumont Hospital, Royal Oak,  Michigan,  48073,  United States
Nebraska
      Creighton University, Omaha,  Nebraska,  68131,  United States
New Jersey
      Robert Wood Johnson Medical Center, New Brunswick,  New Jersey,  08903,  United States
New York
      Krilov, Leonard, Mineola,  New York,  11501,  United States
      Jacobi Ambulatory Care Pavilion, Bronx,  New York,  10461,  United States
      Children's Hospital of New York, New York,  New York,  10032,  United States
      Schneider Children's Hospital, New Hyde Park,  New York,  11040,  United States
      New York Weill Cornell Center, New York,  New York,  10022,  United States
      State University of New York, Syracuse,  New York,  13210,  United States
North Carolina
      Duke Clinical Research Institute, Durham,  North Carolina,  27704,  United States
Ohio
      Koranyi, Katalin, Columbus,  Ohio,  43205,  United States
      Congeni, Blaise, Columbus,  Ohio,  43205,  United States
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States
      Diagnostic Referral Center - Todd's Children's Hospital, Youngstown,  Ohio,  44504,  United States
      Cincinnati Hospital, Cincinnati,  Ohio,  45229-3039,  United States
Pennsylvania
      Albert Einstein Medical Center, Philadelphia,  Pennsylvania,  19141,  United States
      Primary Physicians Research, Inc., Pittsburgh,  Pennsylvania,  15241,  United States
      Children's Hospital Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States
South Carolina
      Levy, Arden, Spartanburg,  South Carolina,  29307,  United States
Tennessee
      Lebonheur Children's Medical Center, Memphis,  Tennessee,  38103,  United States
Texas
      Ward, Mark, Houston,  Texas,  77030,  United States
      T.E.A.M. Research of Seguin, Seguin,  Texas,  78155,  United States
Utah
      American Fork Hospital, American Fork,  Utah,  84003,  United States
Virginia
      Frederic B. Garner, MD, Burke,  Virginia,  22015,  United States

Study ID Numbers:  LOFBIV-PCAP-003
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  May 2, 2002
ClinicalTrials.gov Identifier:  NCT00034736
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08