A Long-term Study of the Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-fluoroquinolone Therapy for Acute Bacterial Infection

This study has been completed.

Study NCT00210639 Information provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

First Received on September 13, 2005. Last Updated on April 26, 2011 History of Changes

Results First Received: April 26, 2011

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Conditions:	Bacterial Infections Pneumonia Otitis
Interventions:	Other: Levofloxacin-treated cohort Other: Comparator-treated cohort

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
LEVOFLOXACIN	Levofloxacin-treated cohort
COMPARATOR	Comparator-treated cohort

Participant Flow: Overall Study

	LEVOFLOXACIN	COMPARATOR
STARTED	122	82
COMPLETED	61	41
NOT COMPLETED	61	41
Lost to Follow-up	42	34
Withdrawal by Subject	10	1
Other	9	6

Baseline Characteristics

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Reporting Groups

	Description
LEVOFLOXACIN	Levofloxacin-treated cohort
COMPARATOR	Comparator-treated cohort

Baseline Measures

	LEVOFLOXACIN	COMPARATOR	Total
Number of Participants [units: participants]	124	83	207
Age [units: participants]
<=18 years	124	83	207
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	3.9 ± 2.52	3.5 ± 2.46	3.7 ± 2.50
Gender [units: participants]
Female	48	40	88
Male	76	43	119
Region of Enrollment [units: participants]
ARGENTINA	16	11	27
BRAZIL	8	4	12
CHILE	10	12	22
COSTA RICA	27	15	42
ISRAEL	2	0	2
MEXICO	0	1	1
PANAMA	0	1	1
UNITED STATES	61	39	100
AgeCategorical [units: participants]
<2 YEARS	16	14	30
2-<6 YEARS	95	62	157
6-<12 YEARS	9	5	14
12-<17 YEARS	4	2	6

Outcome Measures

1. Primary:

Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase [ Time Frame: surveillance phase ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was an observational safety study with no efficacy endpoints. Adverse event data is entered into the appropriate section within this submission.

Results Point of Contact:

Name/Title: Clinical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
phone: 609-730-3158

Publications of Results:

Noel GJ, Bradley JS, Kauffman RE, Duffy CM, Gerbino PG, Arguedas A, Bagchi P, Balis DA, Blumer JL. Comparative safety profile of levofloxacin in 2523 children with a focus on four specific musculoskeletal disorders. Pediatr Infect Dis J. 2007 Oct;26(10):879-91.

Responsible Party:	Senior Director, Compound Development Team Leader
ClinicalTrials.gov Identifier:	NCT00210639 History of Changes
Other Study ID Numbers:	CR004171
Study First Received:	September 13, 2005
Results First Received:	April 26, 2011
Last Updated:	April 26, 2011
Health Authority:	United States: Food and Drug Administration