Musculoskeletal Diseases
Conditions
Keywords
Musculoskeletal Diseases, Musculoskeletal Disorders, Childhood Disease, Bone Diseases, Joint Diseases, Levofloxacin, Quinolones, Bacterial infections
Brief summary
The purpose of this study is to assess the long-term safety of levofloxacin administered to children as therapy for acute bacterial infection.
Detailed description
This is a prospective (look forward using periodic observations collected predominantly following participant enrollment), long-term, comparative, multicenter, observational study (study in which the investigators/physicians observe the participants and measure their outcomes) to monitor long-term the incidence of musculoskeletal (MS) disorders in children who have received levofloxacin or a standard therapy for acute bacterial infection. Approximately 2500 participants who were enrolled in prior Phase 3 clinical studies of the use of levofloxacin for the treatment of acute infectious disease will be observed in this study. The study consists of 3 phases: a screening phase; a surveillance phase; and a musculoskeletal disorder follow-up phase. Safety evaluations will include assessment of an overall incidence of musculoskeletal disorders that occur during the first 60 days after the first dose of anti-microbial therapy. The specific musculoskeletal disorders to be reported are: tendinopathy (inflammation or rupture of a tendon); arthritis (inflammation of a joint as shown by redness or swelling); arthralgia (pain in a joint); gait abnormality (limping or refusal to walk). Other assessments of safety will include interviews using standardized questionnaires to assess the occurrence of musculoskeletal adverse events, physical examinations, and measurement of participants height over the course of 1 year.
Interventions
DRUGNo intervention
This is an observational study. Participants rceiving dosing regimen from the respective Phase 3 levofloxacin clinical studies will be observed in this study.
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 16 Years
Healthy volunteers
No
Inclusion criteria
* Must have taken at least 1 dose of levofloxacin or standard non-fluoroquinolone therapy as part of a Phase 3 levofloxacin clinical study (LOFBIV-PCAP-003, LOFBO-OTMD-001, LOFBO-OTMD-002) to treat an acute bacterial infection * Parent or legal guardian read and signed the informed consent form
Exclusion criteria
* Participants who do not meet the criteria for enrollment in a prior Phase 3 clinical study of levofloxacin or did not take at least one dose of levofloxacin or standard non-fluoroquinolone therapy in 1 of 3 prior Phase 3 levofloxacin clinical studies (LOFBIV-PCAP-003, LOFBO-OTMD-001, or LOFBO-OTMD-002)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase | Musculoskeletal Disorder (MSD) Follow-Up phase (ie, up to 5 years after their first dose of antimicrobial therapy, yearly visits for 4 additional years) | The criteria used to assess Musculoskeletal Adverse Event is based on system organ class Musculoskeletal and connective tissue disorders of MedDRA 13.0. |
Countries
Argentina, Brazil, Chile, Costa Rica, Israel, Mexico, Panama, United States
Participant flow
Recruitment details
For this study, a total of 2233 participants were enrolled; 1620 participants from 2 otitis media studies (LOFBO-OTMD-001, LOFBO-OTMD-002) and 613 from a community acquired pneumonia study (LOFBIV-PCAP-003).
Pre-assignment details
Only 207 participants out of 2233 participants were required for yearly follow-up during the Musculoskeletal Disorder (MSD) follow-up phase.
Participants by arm
| Arm | Count |
|---|---|
| Levofloxacin Participants who received levofloxacin in the previous studies. | 124 |
| Comparator Participants who received comparator in the previous studies. | 83 |
| Total | 207 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 37 | 29 |
| Overall Study | Other | 18 | 12 |
| Overall Study | Withdrawal by Subject | 8 | 1 |
Baseline characteristics
| Characteristic | Levofloxacin | Total | Comparator |
|---|---|---|---|
| AgeCategorical 12-<17 YEARS | 4 participants | 6 participants | 2 participants |
| AgeCategorical 2-<6 YEARS | 95 participants | 157 participants | 62 participants |
| AgeCategorical <2 YEARS | 16 participants | 30 participants | 14 participants |
| AgeCategorical 6-<12 YEARS | 9 participants | 14 participants | 5 participants |
| Age, Continuous | 3.9 years STANDARD_DEVIATION 2.52 | 3.7 years STANDARD_DEVIATION 2.5 | 3.5 years STANDARD_DEVIATION 2.46 |
| Region of Enrollment ARGENTINA | 16 participants | 27 participants | 11 participants |
| Region of Enrollment BRAZIL | 8 participants | 12 participants | 4 participants |
| Region of Enrollment CHILE | 10 participants | 22 participants | 12 participants |
| Region of Enrollment COSTA RICA | 27 participants | 42 participants | 15 participants |
| Region of Enrollment ISRAEL | 2 participants | 2 participants | 0 participants |
| Region of Enrollment MEXICO | 0 participants | 1 participants | 1 participants |
| Region of Enrollment PANAMA | 0 participants | 1 participants | 1 participants |
| Region of Enrollment UNITED STATES | 61 participants | 100 participants | 39 participants |
| Sex: Female, Male Female | 48 Participants | 88 Participants | 40 Participants |
| Sex: Female, Male Male | 76 Participants | 119 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 124 | 6 / 83 |
| serious Total, serious adverse events | 2 / 124 | 3 / 83 |
Outcome results
Primary
Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase
The criteria used to assess Musculoskeletal Adverse Event is based on system organ class Musculoskeletal and connective tissue disorders of MedDRA 13.0.
Time frame: Musculoskeletal Disorder (MSD) Follow-Up phase (ie, up to 5 years after their first dose of antimicrobial therapy, yearly visits for 4 additional years)
Population: Participants (207) who were followed up during the MSD Follow-Up Phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levofloxacin | Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase | 3 Participants |
| Comparator | Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase | 3 Participants |