Trial Outcomes & Findings for A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection (NCT NCT00210639)
NCT ID: NCT00210639
Last Updated: 2014-04-21
Results Overview
The criteria used to assess Musculoskeletal Adverse Event is based on system organ class "Musculoskeletal and connective tissue disorders" of MedDRA 13.0.
Recruitment status
COMPLETED
Target enrollment
2233 participants
Primary outcome timeframe
Musculoskeletal Disorder (MSD) Follow-Up phase (ie, up to 5 years after their first dose of antimicrobial therapy, yearly visits for 4 additional years)
Results posted on
2014-04-21
Participant Flow
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).
Only 207 participants out of 2233 participants were required for yearly follow-up during the Musculoskeletal Disorder (MSD) follow-up phase.
Participant milestones
| Measure |
Levofloxacin
Participants who received levofloxacin in the previous studies.
|
Comparator
Participants who received comparator in the previous studies.
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
83
|
|
Overall Study
COMPLETED
|
61
|
41
|
|
Overall Study
NOT COMPLETED
|
63
|
42
|
Reasons for withdrawal
| Measure |
Levofloxacin
Participants who received levofloxacin in the previous studies.
|
Comparator
Participants who received comparator in the previous studies.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
37
|
29
|
|
Overall Study
Withdrawal by Subject
|
8
|
1
|
|
Overall Study
Other
|
18
|
12
|
Baseline Characteristics
A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection
Baseline characteristics by cohort
| Measure |
Levofloxacin
n=124 Participants
Participants who received levofloxacin in the previous studies.
|
Comparator
n=83 Participants
Participants who received comparator in the previous studies.
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.9 years
STANDARD_DEVIATION 2.52 • n=5 Participants
|
3.5 years
STANDARD_DEVIATION 2.46 • n=7 Participants
|
3.7 years
STANDARD_DEVIATION 2.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Region of Enrollment
ARGENTINA
|
16 participants
n=5 Participants
|
11 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
BRAZIL
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
CHILE
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
COSTA RICA
|
27 participants
n=5 Participants
|
15 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Region of Enrollment
ISRAEL
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
MEXICO
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
PANAMA
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
UNITED STATES
|
61 participants
n=5 Participants
|
39 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
AgeCategorical
<2 YEARS
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
AgeCategorical
2-<6 YEARS
|
95 participants
n=5 Participants
|
62 participants
n=7 Participants
|
157 participants
n=5 Participants
|
|
AgeCategorical
6-<12 YEARS
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
AgeCategorical
12-<17 YEARS
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
The criteria used to assess Musculoskeletal Adverse Event is based on system organ class "Musculoskeletal and connective tissue disorders" of MedDRA 13.0.
Outcome measures
| Measure |
Levofloxacin
n=124 Participants
Participants who received levofloxacin in the previous studies.
|
Comparator
n=83 Participants
Participants who received comparator in the previous studies.
|
|---|---|---|
|
Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase
|
3 Participants
|
3 Participants
|
Adverse Events
Levofloxacin
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Comparator
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Levofloxacin
n=124 participants at risk
Participants who received levofloxacin in the previous studies.
|
Comparator
n=83 participants at risk
Participants who received comparator in the previous studies.
|
|---|---|---|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.81%
1/124 • 5 years
|
0.00%
0/83 • 5 years
|
|
Infections and infestations
Infectious Mononucleosis
|
0.81%
1/124 • 5 years
|
0.00%
0/83 • 5 years
|
|
Infections and infestations
Otitis Media Chronic
|
0.00%
0/124 • 5 years
|
1.2%
1/83 • 5 years
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/124 • 5 years
|
1.2%
1/83 • 5 years
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/124 • 5 years
|
1.2%
1/83 • 5 years
|
Other adverse events
| Measure |
Levofloxacin
n=124 participants at risk
Participants who received levofloxacin in the previous studies.
|
Comparator
n=83 participants at risk
Participants who received comparator in the previous studies.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.81%
1/124 • 5 years
|
0.00%
0/83 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.81%
1/124 • 5 years
|
0.00%
0/83 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Hypermobility Syndrome
|
0.81%
1/124 • 5 years
|
0.00%
0/83 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.81%
1/124 • 5 years
|
0.00%
0/83 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.81%
1/124 • 5 years
|
0.00%
0/83 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Tendon Disorder
|
0.81%
1/124 • 5 years
|
0.00%
0/83 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/124 • 5 years
|
1.2%
1/83 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral Pain Syndrome
|
0.00%
0/124 • 5 years
|
1.2%
1/83 • 5 years
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/124 • 5 years
|
2.4%
2/83 • 5 years
|
|
Nervous system disorders
Spastic Paralysis
|
0.00%
0/124 • 5 years
|
1.2%
1/83 • 5 years
|
|
Surgical and medical procedures
Otoplasty
|
0.00%
0/124 • 5 years
|
1.2%
1/83 • 5 years
|
Additional Information
Director, Clinical Research
Janssen R&D US
Phone: 1 609 730-3158
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60