Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such musculoskeletal conditions is in the general pediatric population.
This study is classified as "interventional" due to study-specific medical examinations and interventions. Regarding the study drug intake, routine administration is observed only, there is no intervention in study drug administration.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,029
Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label
Common used dose and route
Incidence of Arthropathy (Cumulative)
Arthropathy, as assessed by independent safety committee. The committee, after reviewing data related to musculoskeletal events, decided whether each patient had arthropathy or not. Each incidence includes number shown at previous time point, plus any new patients with the event. The 112/20 arthropathies are mentioned in the other Adverse Events section as well.
Time frame: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
Incidence of Nervous System Events (Cumulative)
Any event within the MedDRA system organ class 'Nervous System disorders'. Each incidence includes number shown at the previous time point, plus any new patients with the event.
Time frame: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
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Mobile, Alabama, United States
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Fort Smith, Arkansas, United States
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Corona, California, United States
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Fountain Valley, California, United States
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Long Beach, California, United States
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Orange, California, United States
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Pico Rivera, California, United States
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San Bernardino, California, United States
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San Luis Obispo, California, United States
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Centennial, Colorado, United States
...and 57 more locations