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Pediatric Community-Acquired Pneumonia Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Pediatric Community-Acquired Pneumonia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Pediatric Community-Acquired Pneumonia Clinical research trials and Pediatric Community-Acquired Pneumonia healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Pediatric Community-Acquired Pneumonia. Pediatric Community-Acquired Pneumonia Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Pediatric Community-Acquired Pneumonia clinical trial. Subjects frequently obtain the most expert healthcare possible for their Pediatric Community-Acquired Pneumonia condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Pediatric Community-Acquired Pneumonia  Pediatric Community-Acquired Pneumonia
Pediatric Community-Acquired Pneumonia
For Condition: Pneumonia
Status: Recruiting
Sponsor(s): Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ,
Synopsis: 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).
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 6 Months/16 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 650
Location and Contact Information:
Bocchini, Joseph *Recruiting*
Shreveport, Louisiana, 71130
United States
Recruiting Joseph Bocchini 318-675-6076
Children's Hospital of New York *Recruiting*
New York City, New York, 10032
United States
Recruiting Natalie Neu 212-305-9683
Albert Einstein Medical Center *No longer recruiting*
Philadelphia, Pennsylvania, 19141
United States
No longer recruiting
Maxwell Finland Laboratory for Infectious Disease *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Colin Marchant 617-414-5195
Jacobi Ambulatory Care Pavilion *No longer recruiting*
Bronx, New York, 10461
United States
No longer recruiting
Lebonheur Children's Medical Center *No longer recruiting*
Memphis, Tennessee, 38103
United States
No longer recruiting
St. Luke's Children's Specialty Center *Recruiting*
Boise, Idaho, 83712
United States
Recruiting Thomas Rand 208-381-7330
Children's Hospital Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Ellen Wald 412-692-7489
Children's Hospital of Michigan *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Basim Asmar 313-745-5863
Tampa General Hospital *No longer recruiting*
Tampa, Florida, 33606
United States
No longer recruiting
Koranyi, Katalin *No longer recruiting*
Columbus, Ohio, 43205
United States
No longer recruiting
Paragon Health Services *Recruiting*
Slidell, Louisiana, 70458
United States
Recruiting Eduardo Hernandez 985-781-7337
Congeni, Blaise *Recruiting*
Columbus, Ohio, 43205
United States
Recruiting Blaise Congeni 330-543-8395
Phoenix Children's Hospital *Recruiting*
Phoenix, Arizona, 85016-7710
United States
Recruiting Jeffrey Weiss 602-546-0413
State University of New York *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Leonard Weiner 315-464-5450
Madera Family Medical Group *Recruiting*
Madera, California, 93637
United States
Recruiting Aftab Naz 559-673-3000
University Hospitals of Cleveland *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Jeffrey Blumer 216-844-3310
Southern Drug Research Network *No longer recruiting*
Tallassee, Alabama, 36078
United States
No longer recruiting
Steele, Russell *Recruiting*
New Orleans, Louisiana, 70118
United States
Recruiting Russell Steele 504-896-9820
Stamford Hospital *Recruiting*
Stamford, Connecticut, 06902
United States
Recruiting Hossein Sadeghi 203-967-5949
Kentucky Pediatric/Adult Research *Recruiting*
Bardstown, Kentucky, 40004
United States
Recruiting James Hedrick 502-349-1569
Center for Clinical Trials of San Gabriel *Recruiting*
West Covina, California, 91790
United States
Recruiting Wignes Warren 626-960-4942
Lakeside Children's Clinic *Recruiting*
Metairie, Louisiana, 70001
United States
Recruiting Keith Kappel 504-883-3703
Cincinnati Hospital *Recruiting*
Cincinnati, Ohio, 45229-3039
United States
Recruiting Philip Walson 513-636-3232
Joe DiMaggio children's Hospital *Recruiting*
Hollywood, Florida, 33021
United States
Recruiting Robert Reid 954-989-5010
Krilov, Leonard *No longer recruiting*
Mineola, New York, 11501
United States
No longer recruiting
Diagnostic Referral Center - Todd's Children's Hospital *Recruiting*
Youngstown, Ohio, 44504
United States
Recruiting Jeffrey Blumer 330-884-3944
American Fork Hospital *No longer recruiting*
American Fork, Utah, 84003
United States
No longer recruiting
Duke Clinical Research Institute *No longer recruiting*
Durham, North Carolina, 27704
United States
No longer recruiting
Child First Pediatrics *Recruiting*
Englewood, Colorado, 80112
United States
Recruiting Isaac Melamed 303-770-0926
Peninsula Research Associates, Inc. *No longer recruiting*
Rolling Hills, California, 90274
United States
No longer recruiting
Georgia Clinical Professionals Group *No longer recruiting*
Chicago, Illinois, 30909
United States
No longer recruiting
Schneider Children's Hospital *No longer recruiting*
New Hyde Park, New York, 11040
United States
No longer recruiting
Children's Hospital Oakland *Recruiting*
Oakland, California, 94609-1809
United States
Recruiting Parvin Azimi 510-428-3336
Scottsdale Healthcare *No longer recruiting*
Scottsdale, Arizona, 85260-6709
United States
No longer recruiting
New York Weill Cornell Center *Recruiting*
New York City, New York, 10022
United States
Recruiting Joseph Stavola 212-746-3326
Robert Wood Johnson Medical Center *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Amisha Malhotra 732-235-7894
T.E.A.M. Research of Seguin *No longer recruiting*
Seguin, Texas, 78155
United States
No longer recruiting
Mount Sinai Hospital *Recruiting*
Chicago, Illinois, 60608
United States
Recruiting Leslie Zun 773-257-6957
Frederic B. Garner, MD *No longer recruiting*
Burke, Virginia, 22015
United States
No longer recruiting
Children's Hsopital - San Diego *Recruiting*
San Diego, California, 92123
United States
Recruiting John Bradley 858-966-7785
Chiefland Medical Center *No longer recruiting*
Chiefland, Florida, 32626
United States
No longer recruiting
Comstock, Barton *Recruiting*
Stevensville, Michigan, 49127
United States
Recruiting Barton Comstock 616-473-1499
Children's Hospital of Orange County *Recruiting*
Orange County, California, 92868
United States
Recruiting Antonio Arrieta 714-532-8322
Creighton University *Recruiting*
Omaha, Nebraska, 68131
United States
Recruiting Jose Romero 402-280-1230
Maricopa Medical Center *No longer recruiting*
Phoenix, Arizona, 85008
United States
No longer recruiting
Ochsner Clinical Foundation *No longer recruiting*
New Orleans, Louisiana, 70121
United States
No longer recruiting
Ward, Mark *Recruiting*
Houston, Texas, 77030
United States
Recruiting Mark Ward 832-824-5459
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027
United States
Recruiting Wilbert Mason 323-669-2509
Primary Physicians Research, Inc. *Recruiting*
Pittsburgh, Pennsylvania, 15241
United States
Recruiting Keith Reisinger 412-257-4461
University of Alabama at Birmingham *No longer recruiting*
Birmingham, Alabama, 35233
United States
No longer recruiting
William Beaumont Hospital *No longer recruiting*
Royal Oak, Michigan, 48073
United States
No longer recruiting
Levy, Arden *No longer recruiting*
Spartanburg, South Carolina, 29307
United States
No longer recruiting
University of Florida *Recruiting*
Jacksonville, Florida, 32209-6511
United States
Recruiting Mobeen Rathore 904-244-5331
Raymond Tidman, MD *Recruiting*
Blue Ridge, Georgia, 30512
United States
Recruiting Raymond Tidman 706-632-4400
Additional Information:
Study ID Numbers: LOFBIV-PCAP-003;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034736
Other Pneumonia Studies:
1. Tigecycline for the Treatment of Subjects with Selected Serious Infections Due to Resistant Gram-Negative Organisms
2. Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
3. Tigecycline versus Imipenem/Cilastatin for the Treatment of Subjects with Nosocomial Pneumonia
4. Ventilator-associated pneumonia / Hospital-acquired pneumonia requiring mechanical ventilatory support
5. A Safety and Efficacy Study of Hospitalized Patients with Community-Acquired Pneumonia and Sepsis
Related Studies:
Other Pneumonia Clinical Trials
Other Arizona Clinical Trials
Other Phoenix Clinical Trials
Pediatric Community-Acquired Pneumonia
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