At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,029 enrolled
Drug / intervention
Ciprofloxacin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Open-label, Non-randomized, Naturalistic, Long-term Safety Surveillance, Observational Study of Either Ciprofloxacin (Either as Oral Suspension, Oral Tablets or Sequential IV Followed by Oral Therapy or Purely IV Therapy) or a Non-quinolone Antibiotic (Either as Oral Suspension, Oral Tablets or Sequential IV Followed by Oral Therapy or Purely IV Therapy) in the Treatment of Pediatric Patients With Infectious Diagnoses
In Brief
A Phase 3 clinical trial evaluating Ciprofloxacin and Non-quinolone antibiotic for Infectious Diseases. Completed, enrolled 1,029 participants across 67 sites in 2 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfectious Diseases
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 1999
Primary CompletionJan 2008
First PostedSep 2008
TodayJul 2026
First PostedSep 29, 2008
Enrollment StartOct 1, 1999
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 17.8 years ago
Interventions
Ciprofloxacindrug
Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label
Non-quinolone antibioticdrug
Common used dose and route